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<![CDATA[Position: Mobile Laboratory Instructor Organization: MdBio Foundation (MdBioLab) Mailing Address: 9713 Key West Avenue, Suite 100, Rockville, MD 20850 The Mobile Laboratory Instructor is an enthusiastic individual who presents laboratory inquiry-based activities in a mobile bioscience-learning laboratory for high school students and teachers. The Instructor provides instruction to high school students and teachers aboard the MdBioLab, a custom designed mobile bioscience laboratory inside a 45-foot tractor-trailer that travels to schools throughout Maryland. Instructors present current and relevant hands-on laboratory activities to students. This is a full-time, year-round position. Responsibilities include: • Teaching age appropriate laboratory bioscience activities and extended or enrichment opportunities to Maryland students • Laboratory preparation, set-up and clean up • Develop, write and present bioscience curriculum, activities and materials • Coordinate and conduct professional development for educators • Coordinate and schedule moving, location and routine vehicle maintenance for the MdBioLab • Track equipment, supply and reagent levels and order as necessary; includes monitoring vendor accounts, pricing and completing and submitting purchase orders • Inspect laboratory instruments and equipment and test periodically to ensure functioning within specified standards. Coordinate and schedule all necessary repairs and preventative maintenance as needed Position requirements: Minimum of a B.S. in science or education and two years of laboratory science or teaching science required. The Instructor must have familiarity with micropipettes, recombinant DNA technology, agarose gel electrophoresis and other basic molecular biology techniques or high school classroom equivalent. This position requires an individual with outstanding customer service and attitude who is friendly, outgoing and has the ability to work well as part of a team. The Instructor must be able to work independently, with initiative to manage own workload without much supervision. They must also be flexible and adapt well in unpredictable situations. Extensive travel with possible overnight stays throughout Maryland is required. The Instructor must have own transportation and be available for day, evening and occasional weekend functions. The position reports to the Director of Education and Workforce Programs and will be based on the MdBioLab. The MdBioLab (www.mdbiolab.org) is the flagship education program of the MdBio foundation, a private non-profit organization dedicated to advancing the growth of bioscience in Maryland with a special emphasis on education, training and communications. MdBio foundation is a affiliate of the Tech Council of Maryland (www.techcouncilmd.com). If interested, please send an email replying to this post with a current resume and statement of qualifications.]]>

<![CDATA[Position: Lab Tech Location: Baltimore, MD Salary: $14/hr Terms: Temporary Contract We are looking for a lab tech to start working IMMEDIATELY to support an ongoing project. Responsiblities will include making media, pre-bulk testing, using Ph Meters, scales and working in a GMP environment. Some experience, although minimal, is required. Must hold a H.S. Diploma and have 2+ years experience, or B.S. and relevant course/lab work. This position begins on Monday, so if you are interested in this position please reply to this posting immediately with a copy of your resume and contact information. ]]>

<![CDATA[Summary Description This is a lead HVAC technician position. Responsibilities include, but may not be limited to, the following: • Routine servicing, repair, maintenance and installation of refrigeration, air conditioning, laboratory, building systems and its components. • Performing preventive and corrective maintenance on HVAC, steam boilers, chillers, purified water systems, clean steam systems, pumps & drives, cooling towers, and chemical treatment equipment. • Perform preventive and corrective maintenance on process equipment used in biopharmaceutical manufacturing and/or research including WFI systems, autoclaves, glass washers, CIP systems, centrifuges, bioreactors and fermentation equipment. • Perform routine and emergency repairs. • Troubleshoot and diagnose malfunctioning equipment, systems and components. • Interpret engineering drawings and equipment manuals related to systems, components and parts. • Perform overhauls on equipment, systems and components. • Provide recommendations regarding refrigeration, air conditioning laboratory and building systems maintenance, repairs and installations. • Develop and implement maintenance tasks. All the above mentioned is to be performed on equipment and components such as compressors, condensers, evaporators, valves, coils, cooling towers, boilers, air compressors, cold rooms, warm rooms, ice machines, ice makers, water heaters, ultra-low freezers, purified water systems, heat pumps, motors, belts, bearings, fans, filters, piping, wiring, control systems, thermostats, ducting, ventilators, and other appurtenances such as autoclaves and other lab equipment. • Required to use Microsoft Office Suite, Lotus Notes email, and the C-Works database. • Required to complete any required cGMP documentation, logbooks, work orders, and purchase requisitions. Required to read, understand and work from Standard Operating Procedures and P&ID’s. • Required to supervise contractors and vendors performing work in the facility as needed. Required to participate in on-call rotation and work extended hours when required (weekend work). Position Requirements • HVAC Certification • 5 years experience in refrigeration, air conditioning and heating systems to include boiler maintenance and other building engineering activities. • Must have completed courses in HVAC controls, and refrigeration. • Must be able to read, write and utilize complicated drawings and manuals. • Must have fundamental knowledge of control systems and instrumentation. • Must be willing to follow established company procedures and adhere to FDA regulations. ]]>

<![CDATA[Summary: • Conduct chemical and biological defense as well as conventional weapon research under the close supervision of more experienced technical staff members Developing assays to measure residual elements in final bulk drug substance (such as antibiotic and detergent). • The position is located in Aberdeen, Maryland • Domestic travel anticipated is approximately 10% annually • Compensation will be based on qualifications and experience. Requirements: • Data Collection • Document relevance review determination • Document scanning and PDF conversion • Technical data identification and extraction • Citation creation • Quality assurance capability Required qualifications: • High School Diploma • US Citizen and ability to obtain and maintain a Secret Security Clearance • Strong communication skills (verbal & written) • Team oriented with the ability to work closely with other team members • Detail oriented and capable of working to meet deadlines • Proficient in Word and Excel (Strong Computer Skills) • May be required to pursue various certifications or continuing education units, as needed • Ability to pass skill testing in the area of data quality assurance Desired experience/qualifications: • Working knowledge of chemical and biological defense related items and work • Active Security Clearance Location: Aberdeen, MD Compensation: Compensation based on experience Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests.]]>

<![CDATA[Company seeks Quality Assurance Specialist to join Vaccine department. The candidate will be required to assist with sample tracking for our clinical repository. This individual will also assist with tracking clinical and GMP related materials. This candidate will help in the writing and revising of standard operating procedures. Responsibilities: Handling and tracking serum samples Handling and tracking peripheral blood mononuclear cells (PBMC) Writing and revising SOPs Maintaining inventory on cell banks and virus stocks Minimum Requirements: Bachelors Degree. 0 -2 years experience. Knowledge of principles and practice of current Good Manufacturing Practices (GMPs) a plus. Good organizational skills, verbal and written communication skills. Proficiency in Window based software to include Excel and Word ]]>

<![CDATA[Part time education staff wanted at the Maryland Science Center. Applicants must have completed high school or equivalent. All applicants must be comfortable interacting with the public, show initiative and flexibility, and be willing to learn. Most positions require some weekend availability. Positions available include: Kids Room Staff SpaceLink/TerraLink staff BodyLink Public Programs Please check our website for more detailed descriptions. www.marylandsciencecenter.org To apply for any of these positions, please forward a resume via email and indicate which position you are interested in or check our website for faxing instructions. ]]>

<![CDATA[ Description: Will primarily serve as a technical resource or primary author during planning, preparing, or developing plans for environmental assessments of former DOD properties in the preparation of work plans, SI reports, plans, project status reports, and other technical documents necessary for environmental projects (e.g., SIs, PAs, RI/FS, EE/CAs, TCAs, investigations and remedial actions, ROD amendments, or similar documents). Will also provide support to other professional staff, including review of project analytical data, trend analysis, technical research, procedure development, or procurement support (such as preparing Technical Scopes of Work and evaluating bids). Typically, reports and documents will be prepared under tight deadlines. Expected to work in the field approximately 25% of the time, traveling to field sites across the country. Field work may include providing technical or logistical support, sampling environmental media, or related assignments. Will work directly with the Project Manager or other technical staff. Occasional weekend work should be expected. Requirements: Bachelor's or Master's degree in scientific field (engineering, geology, hydrogeology, biology, chemistry or related scientific field) required. Experience with CERCLA and RCRA regulations, work plans, sampling plans required. Field work, sampling experience, capability, and proficiency necessary. Excellent writing skills and proficiency with Microsoft Word, Excel, and Outlook. Project experience with fixed price projects is preferred. Demonstrated technical writing experience with preparation of technical documents (for example, work plans, RI/FS, sampling plans, waste analysis plans, field investigation reports, Phase I/II assessments, and similar documents). Experience giving presentations at public meetings; excellent oral and verbal communication. Organized, efficient, and accurate document production is needed. Must be able to work within a team environment, with tact and professional demeanor. Travel is required. Work to meet project deadlines necessary. A technical writing sample may be requested as part of the interview process. Additional skills (desirable): Regulatory familiarity with NPDES, CAAA, TSCA, FIFRA. UST and AST regulations and permitting, including applicable state programs desired. Experience in munitions and explosives of concern (MEC)/munitions constituents (MC) investigation activities at DoD sites is a plus. Knowledge of geophysics, geographic information systems and environmental databases. Experience in proposal preparation and cost estimating is a plus.   <a href="http://fa.by/8e27b1" rel="nofollow">Apply Link</a>]]>

<![CDATA[Position: Quality Assurance Associate Location: Rockville, MD Salary: Negotiable Terms: Temporary Contract We are seeking a Quality Assurance Specialist to join our Vaccine department in Rockville, MD. The primary duty for this individual will be to assist with processing raw materials and performing environmental monitoring for our GMP facility. This individual will also assist with the writing and revising of standard operating procedures, creating and revising of raw materials specifications, and status labeling of GMP raw materials. Responsibilities include but are not limited to: • Assist with processing raw materials for the GMP facility. • Writing and revising SOPs • Creating and revising raw materials specifications • Status labeling of GMP raw materials • Performing Environmental Monitoring • Assisting with tracking and shipping GMP materials for vendor testing Minimum requirements: • Bachelors Degree. 0 -2 years experience. • Knowledge of principles and practice of current Good Manufacturing Practices (GMPs) desired but not required. • Good organizational skills, verbal and written communication skills. • Proficient in Window based software to include Excel and Word. Ability to adapt to changing software programs. This position may require periodic weekend/evening work. ]]>

<![CDATA[Leading catering company needs a Freelance Licensed Dietitian to do menu analysis for athletic audience. Any experience in the sport arena will be a big plus. Please email to jsoudry@rougecatering.com]]>

<![CDATA[Biotech/Pharma support company seeks candidates with experience servicing ultra low freezers, chillers, coolers Requirements: -3-5 years experience servicing ultra low freezers, chillers, coolers, incubators -EPA license -MD refrigeration certification -Service areas: Baltimore, Washington D.C., Manassas, York ]]>

<![CDATA[A biotech company, focusing on developing and manufacturing DNA/siRNA transfections in vitro and in vivo purposes, is looking to add two new Technical Sales Representatives for great DC metropolitan area. The primary responsibilities will be to maintain a high level of product knowledge, generate leads, develop opportunities, negotiate/close high dollar sales, maintain existing customer relations and expand company’s exposure in a highly competitive market. Excellent interpersonal, organizational, written and verbal communication skills are essential. This position requires up to 3/4 of the time spent on visiting customers in DC metropolitan area (e.g., NIH, Georgetown University, George Washington University, etc). Requirements: • Bachelor or master’s degree (Medical Science, Biology, or related field of study preferred) • Strong ability to develop and maintain customer relationships • Strong analytical, organizational and project management skills • Ability to work independently to achieve monthly goals • Ability to identify business opportunities in relation to growth strategies • Represent company at scientific meetings, conventions and industry functions as needed • Intermediate to advanced MS Word and Excel skills • Sales experience is a plus • Lab experience is a plus Key Responsibilities: 1. Customer visits and analysis of current and future needs 2. Technical support to current customers and prospects 3. Acquisition of new customers 4. Organization of onsite demonstrations, exhibitions and workshops 5. Develop key relationships in great DC metropolitan area]]>

<![CDATA[ Job Description: As part of our Analytical team, you will be in the laboratory helping to perform protein HPLC analysis, analytical method development for purity and impurity testing, sample qualification, stability studies, mass spectroscopy, formulation studies and protein purification. Additional responsibilities may include training and report generation. Daily interactions may be required to complete assigned tasks. • Perform routine HPLC protein analysis, protein purification and characterization. • Maintain accurate lab notebooks, participate in writing technical reports, analyzing and presenting data in group meetings. • Support product scale-up and manufacturing clinical material • Assist in troubleshooting of manufacturing processes. • Ability to operate specialized laboratory equipment as appropriate to the individual laboratory. • Ability to function in multi-task, fast paced environment. Qualifications: • BS or MS degree in biology, biochemistry, biochemical engineering or chemistry with 0-4 years of relevant experience in pharmaceutical or biologics process development. • *Must be able to work with a small team in a demanding, time intensive, fast paced environment • An understanding of protein purification theory and protein quantization are essential. Hands-on experience with chromatography--in particular experience with Ion-Exchange and Hydrophobic interaction and ultrafiltration/diafiltration are a plus. • The candidate must have excellent verbal and written communication skills and be able to work effectively in a team and independently under general supervision. • The candidate must take a drug screen/physical. ]]>

<![CDATA[Become a Special Education or Science Teacher in a New York City Public School. The NYC Department of Education is seeking excellent teachers are or will be certified in special education or the sciences for the September 2010-2011 school year. We offer competitive salaries and benefits, opportunities to grow and achieve as a professional, and the choice of 1,600 unique schools with their own missions and educational approaches. Recruiters from the Office of Teacher Recruitment and Quality will be interviewing in the DC metro area on Wednesday, March 31, 2010. All qualified teachers certified in one of these subject areas are invited to apply for an interview. For information on the event and eligibility criteria, visit <a href="http://www.teachnyc.net/recruitmentevents" rel="nofollow">http://www.teachnyc.net/recruitmentevents</a> or contact us at teachnyc@schools.nyc.gov. Please indicate that you are interested in obtaining an interview in the DC area. Include your full name, email, telephone number and subject area of certification. ]]>

<![CDATA[ Knowledge and Experience Required 1. Bachelor’s degree in a science related field; advanced degree (MBA, MS, Ph.D.) a plus. 2. Minimum 7 years experience in a biotech research/pre-clinical process or drug development environment desired. A combination of experience that is inclusive of relevant laboratory skills and project management is optimal. 3. Strong preference for candidates with direct experience in microbicides pre-clinical development (formulation, cGMP manufacturing, analytical assay validation and regulatory). 4. Candidates who have experience with small molecule or relevant biologics cGMP manufacturing, coordinating scientific working groups, synthesis of labeled API and formulations, and toxicology/pharmacokinetics are of a particular interest. 5. Display familiarity with relevant FDA regulations & points to consider including: INDs, IBs, & DMFs together with 21 CFR 211, 21 CFR 610,and 21 CFR 58. 6. Maintain proficiency in current vaccine and microbicide products in development, technologies and vendor competencies. 7. Experience working with government agencies is desired, not required. 8. Strong and effective interpersonal skills (both written and oral) 9. Demonstrated ability to work as a strong contributor in a team environment on complex projects 10. Outstanding demonstrated interpersonal skills a must (both written and oral) 11. Proven multi-tasker able to handle multiple projects well; ability to motivate teams, work within aggressive timelines collaboratively with cross-functional departments 12. Proven and demonstrated computer (PC) and software skills including MS Office Suite programs, Internet, email systems a must ]]>

<![CDATA[Aerotek Scientific, LLC is currently hiring for a Bone Density Scanning Technician to work at our client site in the Balitmore, MD area. Position: Bone Density Scanning Technician Summary: Candidate will perform DXA Scans at the Bone Center. Duties: Perform Bone Density Scans with patients ranging from pediatrics through to geriatrics. The person needs to be very comfortable performing the scans on pediatrics. Schedule: We would like to start someone 1-2 days per week, 8:30am–5:00pm. Pay: Based on Experience Certifications: There are no certifications required Equipment: Any Bone Density Scanning equipment Please submit resume and reference information to Thomas Stover at tstover@aerotek.com or contact him directly at 410-657-3013. ]]>

<![CDATA[Shimadzu Scientific Instruments Inc. is currently searching for a Product Specialist who possess a strong scientific and computer background to work with our software product lines. Summary: The individual in this position is responsible for a wide variety of support related functions including, but not limited to, development of technical documents related to marketing, sales, application use, training, repair, maintenance, installation, and phone support of Shimadzu assigned product lines. Travel and customer contact to support assigned product may be required. Additional responsibilities include training customers and SSI staff, as well as, other related duties that may be assigned from time to time. Job Requirements: Incumbent must be proficient at effectively troubleshooting operational, application and other instrument problems in a methodical efficient manner. Additionally, incumbent must be able to act independently in matters not governed by policy to ensure customer satisfaction. Incumbent must have a Bachelor’s degree in the physical, life or natural sciences with at least two years of technical applications experience in the appropriate product line (Data processing/computers/scientific software) or the equivalent experience in maintenance and/or repair of analytical instrumentation. Please visit our website www.ssi.shimadzu.com/employment for a complete job description and to use our apply online feature. SSI is an EOE - M/F/D/V employer.]]>

<![CDATA[JOB OPPORTUNITY – TECHNICAL SALES REPRESENTATIVE IBIDI, LLC ibidi, LLC, a leader in providing solutions for BioMicroscopy, is looking to add a new Technical Sales Representative to the US team. ibidi is an international company which began in Munich Germany and has greatly expanded in the US. We are looking for a motivated and technical individual to help grow and manage new territories in the East and/or West Coast market. This position is geared towards someone who is dedicated to life sciences and research but is more suited to work in the field rather than the lab. The successful candidate will be a self-starter with strong communication skills as well as a forward thinker. This is an amazing opportunity to work for an innovative and fast growing company and correct individual will be provided the tools and support to advance quickly. If interested, please see the extended job description below and send your Cover Letter, CV along with salary requirements to Megan Nicholson at mnicholson@ibidi.com. Relocation to the Madison, WI area is required for a training period To learn more about ibidi, please go to www.ibidi.com Technical Sales Representative ibidi LLC is an innovative company located in Verona, Wisconsin that specializes in solutions for BioMicroscopy. Our distinct line of products is primarily used in cell culture and high resolution microscopy for the advancement of stem cell research, cancer research, live cell imaging, chemotaxis, wound healing, angiogenesis and other cutting edge biotechnologies. ibidi’s broad range of micro-fluidic slides (µ- Slides), universal heating stages, flow pumps and other laboratory products are at work in the most sophisticated industrial, pharmaceutical, academic, clinical and biotech research institutions across the nation. We are currently seeking a highly motivated and dependable individual to join our sales team in Verona, WI as a Technical Sales Representative. Relocation to the Madison/Verona WI area is required for a training period. Upon completion of training there will be the opportunity to relocate to the East or West Coast to continue market development. The primary responsibilities will be to maintain a high level of product knowledge, generate leads, develop opportunities, negotiate/close high dollar sales, maintain existing customer relations and expand ibidi’s exposure in a highly competitive market. Excellent interpersonal, organizational, written and verbal communication skills are essential. This position requires about ¼ to ½ of the time spent on travel throughout the United States. Requirements: • Bachelor’s degree (Medical Science, Biology, or related field of study preferred) • Strong ability to develop and maintain customer relationships through inside sales • Strong analytical, organizational and project management skills • Ability to work independently to achieve monthly goals • Ability to identify business opportunities in relation to growth strategies • Represent ibidi LLC at scientific meetings, conventions and industry functions as needed • Intermediate to advanced MS Word and Excel skills • Sales experience is a plus • Lab experience is a plus Key Responsibilities: Customer visits and analysis of current and future needs Technical support to current customers and prospects Acquisition of new customers Organization of onsite demonstrations, exhibitions and workshops Develop key relationships in East and/or West Coast market If you are a motivated individual looking for professional growth and enjoy working in a fast paced environment, send your CV and salary history to: mnicholson@ibidi.com ibidi LLC is an Equal Opportunity Employer ]]>

<![CDATA[Summary: Part time position (20+ hrs/wk) that could go full time and will be permanent after 3 months. This position will assist a Laboratory customer office in the processing of patient specimens to be delivered to the Laboratory in Carlsbad, California. Essential Duties and Responsibilities: Complete slide prep and phlebotomy requirements for specimens only, as requested or directed. Review and verify that all necessary documentation accompanies collected blood and bone marrow specimens scheduled for Medical Laboratory including: - Review of Test Requisition to ensure all necessary areas are completed - Ensure the client completes any missing information on the requisition. - Ensure insurance information is included - Ensure CBC documentation is included - Ensure specimens are labeled correctly - Packaging of specimens in provided shippers following designated instructions. - Follow all HIPAA guidelines and requirements in regards to patient information. - Communication with Client Services and Logistics regarding Federal Express Tracking information for specimens being sent. - Deliver specimens to Federal Express staffed location as necessary or required. - Monitor and order as necessary specimen shipping supplies to meet client's needs. - Provide additional support to Sales Representative as needed. Required Skills: CERTIFIED PHLEBOTOMIST LABORATRY DOCUMENTATION CUSTOMER SERVICE LABORATORY PROCESSING SPECIMEN PROCESSING ]]>

<![CDATA[Laboratory Technician Description: An opening is available in the Genetic Testing Production Laboratory for a Laboratory Technician. Duties: • Perform routine PCR casework and laboratory maintenance tasks such as sample preparation, amplification, analysis of PCR products, reagent preparation, instrument operation, and equipment maintenance. • Prepare all samples for analysis according to priority and testing set specified, using standard operating procedures (SOPs). • Document all activities by completing quality assurance (QA) forms and interacting with database. • Assist in developing validation studies of new scientific methods and equipment / robotics. • Refine skills and update education by attending various lectures or workshops and by reviewing journal articles. • Observe all laboratory policies, procedures, and quality controls. Documents all aspects of personal performance and maintains testing records. Minimum Requirements: • BS/BA in Biology, Chemistry or related field • Advanced knowledge of Microsoft Office, particularly Microsoft Excel Additional Qualifications: • Experience performing DNA typing on human samples, STR experience preferred • Genotyping or sequencing experience using capillary electrophoresis and Applied BioSystems instrumentation • Prior laboratory experience in a regulated environment (AABB, CLIA, GLP, GMP, or ASCLAD/LAB) ]]>

<![CDATA[Regulatory Affairs Manager/Specialist - IVD Experience Needed -------------------------------------------------------------------------------- Date: 2010-03-05, 7:33PM CST Reply to: job-tmv2f-1630676887@craigslist.org [Errors when replying to ads?] -------------------------------------------------------------------------------- Regulatory Affairs Manager Grifols has been a leader in the healthcare industry since 1940 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols' activities focus on fulfilling the needs of its patients as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed product designed to improve human health. At its Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. The Grifols family of companies, including Grifols Inc., Grifols USA, Grifols Biologicals, Biomat USA and Plasma Collection Center, Inc. For more information, please visit our website: <a href="http://www.grifolsusa.com/" rel="nofollow">http://www.grifolsusa.com/</a>. Grifols Inc. is the company that sets the corporate policies of all Grifols companies in the US (Grifols Biologicals, Biomat USA and Grifols USA). Also, it provides shared services on Human Resources, Information Technologies, Accounts Payables, Controlling, Audits, Planning and Finance and Regulatory Affairs. This company has an immediate opening for a Regulatory Affairs Manager offering an excellent benefits package, including medical, dental, vision, 401(K) plan, life insurance, educational assistance, and generous paid time off. Position Summary: •Reports to the Regulatory Affairs (RA) Director. Incumbent must have excellent written and verbal communication skills, be well-organized, very detail-oriented, and be able to multi-task. The incumbent must be able to interact effectively within project teams to achieve group goals; and must have the ability to withstand pressure when work priorities change and/or timelines accelerate. The position requires negotiation of project completion timelines with internal commercial and external project leaders. Position requires continuous scheduling of activities and projects as demands and target dates change. Job Responsibilities: (This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.) •Responsible for the planning, review and preparation of In Vitro Diagnostics (IVD) documents for pre-IDEs, premarket notification or 510(k), and BLA submissions to the CDRH, CBER, U.S. FDA. •Review IVD performance studies for autoanalyzers and other clinical automation and analysis instrumentation, and diagnostic test kits related to immunology, blood banking, hemostasis and clinical diagnostic test kits in general. •Be familiar with FDA-required standards, e.g., EP-A2, EP6-A, EP7-A2, EP9-A2, EP17-A. •Alert management and information suppliers of gaps in the studies and provide recommendations and action items. •Review FDA IVD guidance documents and update management of changes in the regulatory requirements which will impact the company. •Project planning – write project plans with target due dates to complete milestones. Monitor changes, inform relevant parties involved. Solve problems, take actions as required, and work in an efficient manner to ensure milestones are met by target dates. •Represent the department in meetings, both regulatory and commercial in nature. Interact effectively with quality, regulatory, research personnel within the company, internal business managers and external suppliers/distributors in order to complete projects in a timely manner. •Prepare electronic 510(k) submissions. •Train personnel and write regulatory SOPs. Required Skills, Experience & Education: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). •Mimimum of B.S. degree required. •5 years minimum experience in regulatory submissions in the in vitro diagnostic device industry, preferably in immunology, blood banking, clinical chemistry and hemostasis, and with both instrumentation and reagents. •Strong computer skills required. Knowledgeable in Access, Word, Excel, Statistical software, e.g., Analyse-It •Excellent verbal and written communication skills – must have technical writing ability. •Strong interpersonal skills with ability to interact with personnel at all levels. •Must be capable of multi-tasking with the ability to work well with others in a TEAM environment. To submit your resume please click or copy & paste the link below, or visit our Careers Website at www.grifolsusa.com <a href="http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&company_id=16052&jobid=216852&jobboardid=632" rel="nofollow">http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&company_id=16052&jobid=216852&jobboardid=632</a> Location: Los Angeles Compensation: Salary Depends on Experience, generous PTO, benefits, 401k matching ]]>

<![CDATA[Laboratory Technician Manufacturing & Process Development Rockville, MD Summary: The Laboratory Technician is a member of the team developing and manufacturing vaccines. This position provides lab support to all laboratories in accordance with GLP and GMP procedures. Cleans and sterilizes all glassware, plastic ware, tools and other items related to GLP & GMP. Performs critical cleaning of the manufacturing facility and equipment. Performs media preparation, hazardous waste and sharps disposal, freezer, refrigerator and incubator monitoring. Duties & Responsibilities: • Clean and sterilize all GMP glassware, plastic ware and lab utensils for use in the GMP fermentation following established procedures • Maintain appropriate stock levels of prepared glassware for laboratories • Assist in the weighing of media components for GMP and research fermentation • Assist in GMP and research fermentations as needed. • Clean and sanitize cGMP fermentation and purification labs. • Decontaminate and dispose of all trash from all labs as appropriate following established SOPs • Handle hazardous waste coordination for buildings 1 and 3; identify hazardous materials and how to handle/dispose of them safely. • Draft and/or revise SOPs for operation of all glassware equipment • Provide information to Materials Management as needed and maintain stock levels of lab supplies • Monitor and record temperatures of walk-in cold room and warm room (37 degrees C) and incubators, refrigerators, and Freezers in building 1, 3 &4 • Replace recording charts as assigned on a weekly basis or as appropriate • Assemble equipment for laboratories as needed • Miscellaneous duties include preparation of media, reagents and buffers, cleaning water baths, filling pipette boxes, etc. • Provide support to Materials Management as requested. • Assist in GMP and research fermentations as assigned. Role Flexibility: It is understood that the incumbent will be expected to display some flexibility and, when pertinent, be able to work in other priority areas within the laboratory. Such transient changes in duties will not represent a change in status and will not place an onerous burden on the incumbent. Qualifications & Requirements: • High School diploma required. Associate’s Degree in a scientific field preferred; can be offset with one to two years experience in a related field. • Experience in Good Manufacturing Practice • Aseptic handling techniques are highly desired. • Computer proficiency with office applications and electronic mail. • Must be careful and thorough, with a high degree of attention paid to SOPs within the laboratory setting. • Ability to work as part of a team, communicates problems or ideas effectively, and possesses tolerance for repetitive tasks. • Able to work flexible hours including evenings and weekends • PHYSICAL DEMANDS: • Ability to occasionally lift more than 100 pounds Hazardous Working Conditions: • Exposure to several laboratory equipment units that require prior training • Potential for chemical, biological, and sharps exposure ]]>

<![CDATA[A privately owned company in Maryland specializing in instruments for optical radiometry is seeking additional staff. A degree in the physical sciences (physics or optics) or engineering (electrical, software, mechanical) plus several years experience is preferred. Advanced degrees are a plus. Experience should include instrument development for optics, lasers, radiometry, remote sensing, metrology or aerospace. Knowledge and familiarity with lasers, optics, vacuum and cryogenic techniques, analog and digital circuit design, embedded C/C++ strongly desired. The ideal candidate for this position is comfortable working independently and in small groups to develop instruments that meet customer needs, assisting in solicitation of funding, and carrying through phases of development from concept to prototype. Email cover letter describing interest in position, CV, salary history, and contact information for three references (all in PDF format only) bestscientificjobs@gmail.com Only submissions in PDF format will be reviewed, all other formats will be deleted without review! ]]>

<![CDATA[Aerotek Scientific, LLC has an immediate opening for a qualified Lab Technician with experience performing PCR amplification in a regulated environment. Please see minimum requirements and job duties listed below. Minimum Requirements: -BS/BA in Life Sciences required (Biology, Chemistry, Biochemistry) -Advanced knowledge of Microsoft Excel -Minimum 6 months performing PCR amplification in a regulated environment -Experience running PCR with human samples -STR experience a huge plus -Genotyping and/or sequencing experience using capillary electrophoresis and ABI (Applied BioSystems) instrumentation -Experience in a regulated environment (AABB, CLIA, GLP, GMP, or ASCLAD/LAB) Job Duties: -Perform routine PCR casework including sample preparation, DNA amplification, analysis, reagent preparation, and equipment maintenance. -Prepare all samples for analysis according to standard operating procedures (SOPs). -Document all activities via QA forms and database. -Assist in developing validation studies of new methods and instrumentation. -Maintain laboratory notebooks and records according to established SOPs and standards. Please submit resume and reference information to tstover at aerotek.com or contact him directly at 410-657-3013 Required Skills: DNA/PCR GENOTYPING APPLIED BIOSYSTEMS HUMAN SAMPLES About Aerotek: Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. ]]>

<![CDATA[Position: Project Manager (Microbicides) Location: Silver Spring, MD Salary: Negotiable Terms: Permanent/Full-Time Responsibilities: • Provide project management expertise in the planning & execution of pre-clinical vaccine and/or microbicide development projects. • Lead cross-functional project teams responsible for supporting product development through pre-clinical studies, cGMP manufacturing, release testing & IND submission. • Ensure project priorities & decisions are communicated & are consistent between teams. • Determine activities required & prepare a detailed scope of work specific for each project to include project milestones, schedules, timelines and determine resources required to perform activities • Budget preparation • Identify areas where subcontractors are required, review proposals and select optimal subcontractors for the project. • Determine potential areas of difficulties & prepare back-up strategies & subcontractors. • Define technical capabilities required to perform specific tasks & manage subcontractors • Utilize database to store all information regarding the products prepared under contract. • Communicate all project issues/needs to Project Leaders & ensure that all deliverable goals are met. • Ensure project priorities & decisions communicated are consistent between teams & support the overall program. • Delegate project workloads; maintain an understanding of all projects within the group and set goals & objectives. The qualified candidate will provide complete program support, maintain & implement on-going improvement & cost containment programs to design more efficient ways to schedule & execute projects as well as evaluate the use of alternative procedures to improve efficiency & reduce costs. Required Experience: • Bachelor’s degree in a science related field; advanced degree (MBA, MS, Ph.D.) a plus. • Minimum 7 years experience in a biotech research/pre-clinical process or drug development environment desired. A combination of experience that is inclusive of relevant laboratory skills and project management is optimal. • Strong preference for candidates with direct experience in microbicides pre-clinical development (formulation, cGMP manufacturing, analytical assay validation and regulatory). • Candidates who have experience with small molecule or relevant biologics cGMP manufacturing, coordinating scientific working groups, synthesis of labeled API and formulations, and toxicology/pharmacokinetics are of a particular interest. • Display familiarity with relevant FDA regulations & points to consider including: INDs, IBs, & DMFs together with 21 CFR 211, 21 CFR 610,and 21 CFR 58. • Experience working with government agencies is desired, not required. • Proven multi-tasker able to handle multiple projects well; ability to motivate teams, work within aggressive timelines collaboratively with cross-functional departments ]]>

<![CDATA[POSITION SUMMARY As Clinical Scientist, support the development of one or more oncology programs from pre-phase 1 through phase 3 and global registration. DUTIES & RESPONSIBILITIES Responsible for working collaboratively with the medical lead and team to execute the clinical program(s). Specific role will include some or all of the following responsibilities: Assist in planning, executing and reporting global clinical trials Conduct medical review of adverse events Assist in interpretation of efficacy and safety data from clinical trials Assist in ensuring regulatory compliance for clinical trials and reporting Assist in writing and designing standard protocols and amendments Assist in developing publications, abstracts, presentations, and/or clinical sections of regulatory documents. QUALIFICATIONS Basic qualifications: RN/Pharm.D. or equivalent (BA/BS/Ph.D. may be considered if the candidate has substantial oncology clinical research experience) 2-3 years oncology clinical research experience in an academic or in an industry setting Preferred qualifications: Proven scientific writing skills, with strong inter-personal, written/verbal communication skills Apply Link: <a href="http://bioemployment.jobamatic.com/a/jbb/job-details/198454" rel="nofollow">http://bioemployment.jobamatic.com/a/jbb/job-details/198454</a>]]>

<![CDATA[Our Client Company: A successful, well-respected public company providing leading edge oncology research and treatment options for physicians and their cancer patients. Title: Pre-clinical Evaluation Sales Representative Department: Business Development; Reports to: VP-Scientific Operations (and maintains close working relationship with Director-Business Development) Salary: Competitive with Sales Performance Related Bonuses Education: Minimum of Masters Degree in Biology / Pharmacology or similar Life Sciences field strongly preferred, MBA a significant advantage Experience: Minimum 3-5 years experience in developing commercial relationships with medium to large Pharma and Biotech companies leading to sales of services in the area of pre-clinical and clinical development enabling technologies, proteomics and genomics tools, molecular diagnostics and systems biology, etc. PRIMARY FUNCTIONS AND RESPONSIBILITIES: • Reduce to practice and execute the company’s marketing and sales strategy for its pre-clinical technology platform as a service to biotech/pharma drug developers. Manage the follow up processes with the various contacts in the leads database. • Target potential biotech/pharma clients by generating and developing leads into business opportunities. • Communicate with pharmaceutical and biotechnology companies to present the Company’s pre-clinical platform. Manage the marketing collateral to be used in various marketing campaigns. • Coordinate meetings and presentations between Champions senior scientists and target companies’ decision makers. • Prepare business proposals working closely with VP of Scientific Operations. SKILLS AND ABILITIES: • Proven track record in generating sales of pre-clinical and clinical development tools and technologies to medium to large pharma and biotech companies. • Extensive experience in managing and driving rapid growth of innovative service offerings. • Extensive knowledge and understanding of the pre-clinical and clinical drug development process. • Knowledge of cancer genotypes and tumor characterization including: gene expression profiling, oncogene mutations, comparative genomic hybridization (CGH), and proteomics. • Demonstrated ability to interpret and communicate scientific data to internal and external colleagues. • Demonstrated ability to work effectively and productively in a team-oriented environment while maintaining a strong sense of integrity and confidentiality. • Creative problem-solving skills and the ability to exercise sound and accurate judgment in making timely decisions. • Superior planning, organizational, computer, written and verbal communication skills and possess the ability to network and negotiate effectively. • Demonstrate accountability and responsibility for own work, observe safety and security procedures. EDUCATION AND EXPERIENCE: • Masters degree in Biology / Pharmacology or similar Life Sciences field (MBA a significant advantage) • Minimum 5 years experience in developing commercial relationships with medium to large Pharma and Biotech companies leading to sales of services in the area of preclinical and clinical development enabling technologies, proteomics and genomics tools, molecular diagnostics and systems biology THIS OPPORTUNITY OFFERS: • Competitive compensation and benefits • Committed team environment • Daily interaction with the world’s leading experts in cancer treatment and drug development Interested candidates are encouraged to submit resume to (our recruiting consultant): Pamela@salesexpertexecutiverecruiters.com ]]>

<![CDATA[Laurel, MD based firm seeks motivated individual who has an interest in pursuing a career in enviromental compliance. Experience helpful but not required. Competitive salary and benefits. Email cover letter, resume and salary history/requirements. EOE. ]]>

<![CDATA[Position: Stability Coordinator Location: Annapolis, MD Salary: Negotiable Hours: Standard Job Decsription: This position is responsible for the management of ICH and GxP compliant stability programs for the company’s phase I/II products. Track testing time points, coordinate stability studies, and ensure samples have been put on test. Work with QA/QC management to ensure appropriate scheduling of sample testing. Author stability protocols and final reports. Analyze, summarize, and trend resulting data. Responsibilities/Competencies: - Coordinate and run stability studies for Company’s Phase I/II products. - Author stability protocols and final reports. - Manage time points for testing, ensure samples are shipped to contract laboratories for testing. - Analyze, summarize, and trend data. - Maintain working knowledge of SOPs, relevant GxP regulations and ICH guidelines. - Work with technical personnel and with other quality organizations within the company. - Assist with regulatory inspections or corporate audits. - Must have strong problem solving and negotiation skills - Ability to interact professionally at multiple levels within a client oriented organization - Able to manage multiple and varied tasks, and prioritize workload - Ability to diplomatically address sensitive issues confidentially and professionally - Ability to work consistently in a fast-paced environment - Working knowledge of regulations - Broad knowledge of the drug development process, ICH, GxP guidelines, and applicable regulations is essential. Education/Experience: - B.S. in Chemistry, Biology or a related Life Science - 5+ years of experience in Quality role within the biotech or pharmaceutical industry. - 5+ years specifically in Stability Coordination - Experience with drug development, clinical research, regulatory compliance, clinical study monitoring or equivalent - Proficiency in other compliance disciplines, i.e., GLPs, GDP, GxPs ]]>

<![CDATA[Lab QC Auditor Job Description: Aerotek Scientific is currently accepting applications for a Quality control Auditor with experience auditing Laboratory Data. Please see specifics below and apply only if you meet all requirements. Job Duties: -Audit data obtained from HPLC analysis from quality control perspective to ensure accuracy of data and compliance to established GMP and SOPs. -Review laboratory data, including graphs, spreadsheets, laboratory notebooks, etc. -Locate any red flags and notify QC Manager and analysts of errors for correction. Job Requirements: -Requires BS/BA in Life sciences with a minimum of 3+ years of auditing of HPLC data from a quality control perspective. -Experience auditing GC, GC/MS or LC/MS data is applicable as well. -Must have QC experience (not QA) in actually reviewing the data from the instrument analysis for accuracy and completeness Please submit resume and reference information to tstover at aerotek.com or contact him directly at 410-657-3013. All referrals are always welcomed and encouraged. Required Skills: QUALITY CONTROL HPLC GCMS LCMS About Aerotek: Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. ]]>

<![CDATA[Call Center Nurse Job Description: Responsibilities: - Fulfill the primary clinical communication role between the Company and the care providers and members/patients of clients of the Company; - Complete telephonic health risk assessments that facilitate patient stratification and the identification of appropriate evidence-based interventions designed to improve patient health outcomes; - Based upon ongoing reviews of accumulated patient information, implement interventions and services according to pre-established protocols and care plan guidelines designed to achieve chronic care program patient goals; - Communicate professionally with patients, providers, and caregivers to obtain or provide information, including completing telephonic health counseling and education calls; - Appropriately document all relevant information regarding patients and providers; - Adhere to all confidentiality and HIPAA requirements as outlined within Operating Policies and Procedures in all ways and at all times with respect to any aspect of the data handled or services rendered in the undertaking of the position; and Job Requirements: - Registered Nurse (RN); - Familiarity with chronic care or disease management programs; - Demonstrated phone communication experience; - Ability to manage and meet deadlines; - Highly computer literate and detail oriented; - Professionally skilled in personal presentation, verbal, and written communication; and - Meticulous organizational skills Required Skills: REGISTERED NURSE UTILIZATION MANAGEMENT/CASE MANAGEMENT CALL CENTER For consideration please contact Matthew Teeters @: mteeters@aerotek.com (410) 567-8019]]>

<![CDATA[CAPE, Inc. (www.cape-inc.com) is recognized for providing superior turnkey services in four primary service areas: Environmental Remediation, Construction Services, Fuel Systems, and specialized services for the Dept. of Energy (DOE). CAPE is nationally recognized by clients for superior service and consistently commended for safe site management, maintenance of rigorous quality assurance/quality control measures, dedicated, hard working project management and outstanding regulatory agency relations. Our Columbia, MD office is looking for a Project Chemist to prepare Uniform Federal Policy Quality Assurance Project Plans within chemistry services, assist in the preparation of proposals and increase the efficiency of chemistry services for internal and external clients. Responsibilities: Position will be responsible to provide chemistry and data management support to the project team. Ensure that all chemical data acquisition activities meet legal, regulatory and program requirements resulting in defensible data. Tasks include establishing project data quality objectives, data validation, data reviews, data management and automated data reviews, and laboratory contract management. Provide data needs to Remedial Investigations, Feasibility Studies, Conformation Sampling, Work Plans, Risk Assessments and Completion Reports. As applicable to the specific project, the Project Chemist must also have knowledge of environmental analytical chemistry methodologies, chemistry of remedial treatment technology, chemical fate and transport, and experience in the sampling and analysis of toxic/hazardous chemicals in environmental matrices. Minimum Work Experience Requirements: A minimum of 5 years experience with broad-based knowledge of data validation and analytical QA/QC for various government entities. Experience must include data validation, data management, field sampling and writing and implementing SAPs, QAPP’s and FSP’s. Must have working knowledge of EPA Methodologies, laboratory quality/analytical practices and project implementation requirements. Candidate must have demonstrated understanding of DoD requirements for various CAPE Clients (AFCEE, USACE, etc) as well as multiple EPA Regions where CAPE executes work. Minimum Education & Training Requirements: Bachelor’s degree in Chemical, Environmental, Biological Sciences, Physical Sciences or Engineering, with at least thirty (30) semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, at least six (6) semester hours of physics, with demonstrated experience in areas of environmental sampling and analytical testing relevant to the project. Background in theoretical chemistry with hands-on field experience required; experience with sampling and analysis. Good working knowledge of databases, MS Word, MS Projects and MS Excel. 40 Hour HAZWOPER certification. Minimum Physical Requirements: Physical ability to oversee project activities as related to the position. Candidates must successfully pass standard CAPE pre-employment physical examination, drug and background screens and have the ability to use safety and respiratory protection equipment as required. Candidates must meet minimum work/education & training/physical requirements to be considered. CAPE offers competitive salaries and benefits; relocation assistance will not be considered for this position. Please submit your resume directly to our website at www.cape-inc.com. Follow the “Careers” link to the Project Chemist/Columbia, MD (610009E) position to apply. No phone calls please. CAPE is an Equal Employment Opportunity Employer and does not discriminate on the basis of race, color, sex, national origin, religion, age, disability, or veteran status in admission or access to, or treatment of employment in, its programs or activities. ]]>

<![CDATA[Chesapeake Urology Associates, the premier Urology practice in Maryland, is seeking a Histotechnologist Supervisor for its new Laboratory in Catonsville, MD. The Histology Technologist Supervisor will ensure the efficient operations of our Histology laboratory. Working under the direction of the Director of Pathology, you will coordinate a wide variety of administrative, personnel, technical and quality assurance activities. This person will also be responsible for preparing, processing, and staining of tissue specimens for review by the pathologists. Duties and Responsibilities: · Responsible for oversight of the pathology lab while under the direction of the Director of Pathology. · Provide direction and supervision to Histotechnologists and Laboratory Technicians/Assistants. · Accessioning, grossing, embedding, microtomy, performing H&E and papanicolau staining and coverslipping all surgical/cytology specimen slides for microscopic analysis. · Loading tissue blocks on the processor. · Maintenance and troubleshooting of equipment and automated instrumentation within the laboratory · Modify and validate procedures and methodologies for immunohistochemistry , special staining and other related staining. · Accurately process, prepare and stain Cytology specimens to enable the pathologist to render a diagnosis · Organizing of cases by matching slides with paperwork and/or laying slides out in slide folders · Assists Director in meeting department regulatory agency requirements (CAP, CLIA, etc.) · Performs quality control procedures per protocol and completes necessary documentation. Qualifications: · A minimum of five years prior experience in a Histology technical position; one years serving in a supervisory role · B.S. or related degree with HT or HTL certification · Excellent embedding, sectioning and histology techniques with human tissues · Well versed in writing SOPs and Quality Control documents · Excellent computer software and data analysis skills · Strong oral and written communication skills · Strong Customer service/relations skills · Ability to multi-task, is self-motivated, reliable, accountable and conscientious in meeting timelines · Experience and certification in Immunohistochemistry and special staining required · UroVysion FISH testing experience highly desirable.]]>

<![CDATA[A position is available for a Research Technician at the Carnegie Institution, located on the Johns Hopkins Homewood campus in Baltimore. The lab is focused on understanding the pediatric eye cancer, retinoblastoma. A B.Sc. or M.Sc. in biology or a related field is required with at least 2 years additional experience in molecular biology, cell biology or mouse genetics. Carnegie benefits are excellent. Please send CV and contact information for three references to macpherson99@gmail.com]]>

<![CDATA[Principal Research Associate-21390 Job Responsibilities/Department Description: The selected candidate will work as part of a fast-paced team in a GLP setting to be responsible for development, optimization and validation of immunoassays for assessment of immunogenicity in human serum samples. This position includes conducting validation studies, writing validation reports, and delivering oral presentations. The selected candidate must be able to work with minimal supervision and be able to handle multiple projects at a time. He or she must be able to independently define and implement a series of experiments to approach problems as well as independently analyze, evaluate, and organize generated data. Effective oral and written communication skills are necessary Basic Qualifications: BS degree in Chemistry, Biology, or Biochemistry with 9 years of industrial experience or MS degree with 7 years of industrial experience is required. Experience in immunoassay development, particularly ELISA, is also required. Preferred Qualifications: Experience with GLP and FDA guidelines. Experience with SoftMax and Prism is preferred along with some familiarity with statistics. Job: Research And Development Primary Location: United States-Massachusetts-Framingham Shift: Day Job Job Type: Regular Employee Status: Regular Apply Link: <a href="http://bioemployment.jobamatic.com/a/jbb/job-details/195339" rel="nofollow">http://bioemployment.jobamatic.com/a/jbb/job-details/195339</a> ]]>

<![CDATA[ Validation, Inc. is a pharmaceutical, biotech and medical device full service company.  We are seeking We are seeking qualified technical writers, validation engineers, process engineers, commissioning engineers and CIP/SIP experts.  Please apply at <a href="http://www.validation-inc.com/careers" rel="nofollow">http://www.validation-inc.com/careers</a>.]]>

<![CDATA[Position Description: · The Quality Specialist I is responsible for monitoring systems in support of FDA regulations and ISO standards. · Review data, participating in investigations and conducting routine process analyses. · Position will support all aspects of Labeling Systems, including change control, product label printing and inspecting and inventoried label inspection. Position Requirements: · BA/BS or scientific experience required. · Must have background in cGMP compliance in support of medical device and/or pharmaceutical manufacturing operations. · Working Knowledge of cGMP, QSR's ISO standards and other applicable regulations is required. · 1-3 years experience in warehouse environment. · Ability to audit processes and procedures effectively. · Effectively interact with peers and be flexible. · Proficient in MS computer applications · Strong written and oral communication skills are necessary · Be able to make informed decisions ]]>

<![CDATA[Laboratory Validation Associate in Frederick, MD Skills: Temp mapping (a must) Kaye Validator SIP/CIP Tanks SIP/CIP Washers SIP Autoclaves Technical report writing (IOQ's and PQ's) Duration: 3 months Start Date: ASAP ]]>

<![CDATA[Techwriter/Validation Associate Immediate in Frederick, MD "software" controls side rather than a person with wet lab experience. The contract will run from mid-March through May. Validation, automation (Allen Bradley), commissioning and manufacturing experience (biotech, pharma). Experience writing, reviewing, PCS/CP documents, automation documents for the project, SOP's, reports, etc. Experience coordinating, organizing and reviewing pre-existing documents. ...depending upon level of experience may: Review, approve and sign-off on Project Documents related to Manufacturing/Validation. They will need to have upstream/downstream, centrifuge manufacturing experience. ]]>

<![CDATA[ Responsible for mechanical engineering design and development efforts on multi-disciplinary projects to produce technically sound medical instrumentation. Participates in the project planning and insures that schedule milestones are met. DUTIES AND RESPONSIBILITIES: Develop design input (specifications) for mechanical systems in instrumented products. Lead or be in sole responsibility for the detail design of mechanical subsystems. Apply engineering principles, analytical skills, and empirical methods to develop statistically robust designs. Design products to meet cost targets. Prepare cost estimates of mechanical components and assembly labor. Accurately estimate work effort for specific engineering tasks for schedule allocation of mechanical engineering manpower. Lead, contribute to, and participate in design reviews. Thoroughly assess the ability of proposed designs to meet specified requirements, including manufacturability. Assist in test planning and development to insure instrument systems and sub-systems conform to requirements on reliability and robustness. Complete assignments within established schedules and budgets. Interact closely with software, systems, and electrical engineering functions to develop comprehensive solutions to design problems. Generate engineering documents, drawings and specifications to internal and industry standards, including ASME Y14.5M-1994 Dimensioning and Tolerancing. Conform to the requirements of ISO 9001 and CGMP standards for the design and development of medical devices. KNOWLEDGE AND SKILLS: Demonstrated application of engineering principles and techniques, including heat transfer, fluid mechanics, and kinematics and dynamics as applied to machine design. EDUCATION AND EXPERIENCE: A Bachelor's Degree in Mechanical Engineering with at least five years relevant experience. Experience with solid modeling CAD applications with large assemblies in team environments. SolidWorks and COSMOS experience required. ]]>

<![CDATA[Position Summary: The Clinical Project Lead (CPL) is responsible for leading the planning, negotiating, scheduling initiating and monitoring of clinical trials of moderate to high complexity in the women's health and /or sexually transmitted diseases field. The CPL leads internal and external CRAs to ensure compliance with device and PMA regulations and smooth conduct of clinical trials. The CPL is responsible for preparing reports of study results for investigators, assisting in preparation of regulatory submissions, and supporting publication activities. The CPL will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities. The position reports to the Medical Manager, Medical Affairs. The CPL is responsible for leading the execution of complex clinical projects and must work both independently and in a team environment. Functional Responsibilities: 1. Responsible for leading planning, budgeting, executing, and monitoring clinical evaluations of products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products. 2. Uses past clinical experience to support project planning and execution related to medical procedures performed during clinical trials related to women's health projects. 3. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures. Specific Responsibilities: · Manages all activities related to multi-center trials. · Coordinates activities with contract research organizations (CRO). · Leads project-related activity of internal and external Clinical Research Associates. · Screen, select, and qualify principal investigators and investigational sites. · Conduct negotiations of clinical site budgets and contracts. · Conducts "monitor training meetings". · Coordinates monitoring visits and reviews monitoring reports. · Mentor more junior clinical operations personnel. · Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials. · Conducts feasibility (interviews investigator and/or CRC, assesses investigator's ability to meet enrollment requirements, etc..). · Monitor clinical data and identify trends. Participate in data analysis planning. · Develop medical project schedule and track tasks and provide back-up strategies to meet overall project schedule. · Plan availability of supplies and shipment of materials. · Coordinate training of clinical evaluation participants in study products and procedures. · Monitor sites to assure that the Protocol is understood and followed. · Communicate results of data analysis to each clinical center and actively support the publication and presentation of results by investigators. · Support the reporting of performance data to regulatory authorities. · Anticipate 25%-35% travel (primarily domestic; international travel a possibility). Qualifications Education and Experience · BSN with clinical nursing · Minimum 5 year in project management experience · Five or more years experience in clinical trials in the medical device industry or in oncology device trials preferably in a CRO environment or with a device sponsor with PMA experience. · Clinical Research Certification is preferred Knowledge and Skills · Deep knowledge of device regulations including PMA regulations. Working knowledge of Good Clinical Practices, human subject protection regulations, safety data monitoring, · Must have excellent interpersonal, presentation, writing and communication skills. · Must have strong knowledge of scientific study design and data analysis. · Must have strong computer skills (MS Office, including Project, Word, Excel, Access, PowerPoint, ) -- prefer working knowledge of statistics and data analysis- preferred skills in database management. · Ability and willingness to travel to domestic (and possibly) international locations as necessary (anticipate 25%-35% travel) ]]>

<![CDATA[Vaccine Manager Frederick, MD Duties: Work involves the planning, direction, and coordination for the development of drugs and vaccines from Milestone through production and sustainment. These products are to be utilized by the military for protection against biological warfare agents infectious disease and chemical warfare threat agents. Tasks include the preparing of overall systems plans and programs, developing requirements for work and resources, and initiating phases required in terms of milestones to be achieved. The incumbent ensures development of drugs and vaccines through an identified cost and event life-cycle acquisition process. Responsibilities include: • Serving as an authority in the field and applying a broad background of experience and specialized knowledge to oversee development of vaccines, chemical defense, biological defense, and combat casualty care pharmaceutical products. • Understanding the Food and Drug Administration (FDA) requirements to obtain FDA approval of the developed products are required. • serving as the authoritative expert on all regulatory matters concerning the development of pharmaceutical systems; and maintaining the necessary liaison and interface with other Government agencies, industry, laboratories, and contractors to remain cognizant of the pharmaceutical systems/product development effort and to apprise interested parties of status of development and other requirements. • Serving as a substantive participant in Integrated Product Teams is also required. • Skills and knowledge are required to comply with acquisition level III (in accordance with DODD 5000.1, DODI 5000.58.1 and/or other DA and/or DOD policy). • Comprehensive knowledge of Food and Drug Administration, DoD, DA and JPEO-CBD acquisition, acquisition management and fiscal policies, procedures and processes in order to plan, develop, coordinate, implement, direct and manage requirements/acquisition activities for JPM-CBMS organizations and activities. • Ability to conduct both short and long range studies or analyses associated with JPM-CBMS acquisition or acquisition management goals or programs which directly affect the Commands overall mission. • Serve as Vaccine Manager responsible for pharmaceutical development and program management that entails planning, budgeting, administration and evaluation of advanced development activities focused on obtaining FDA-approval or licensure of pre-treatment medical countermeasures, and planning and managing the acquisition of new/developed medical countermeasures for DoD use. • Provide scientific, program management, and DoD acquisition expertise in coordinating biodefense research and development activities and initiatives relevant to development of assigned vaccine or medical countermeasure. • Manage a comprehensive program of advanced development for cost, schedule and performance acquisition of assigned vaccine or medical countermeasure. Specifically, analyze the expected impact of contemplated budget revisions, program adjustments, economic trends, or directives from higher echelons upon the assigned project and takes independent action to minimize adverse effects and provide information to DoD senior leadership. • Manage the project through integration of the DoD acquisition process and the FDA regulatory process. • The supervisor provides assignments in terms of broadly defined objectives. Results of work are considered technically authoritative and normally accepted without significant change. Completed work is reviewed for feasibility in relation to requirements, and for conformance with overall policy and program objectives. • Performs other duties as assigned. Requirements: • Ability to communicate effectively, both orally and in writing, with a variety of audiences, including technical, professional and administrative, at all organizational and hierarchical levels. • Ability to research, analyze, interpret and apply rules, regulations, and procedures in the area of DoDI 5000.02 and the FDA regulations • Ability to establish and/or lead teams to carry out projects or programs • Ability to give oral presentations • Ability to communicate in writing • Ability to establish and maintain relationships with key individuals/groups outside immediate work unit In-depth knowledge of JPM-CBMS organizational structure, missions, programs, and organizational relationships, to include non-JPM-CBMS supporting activities, such as other MACOMs, Federal Agencies and uniquely qualified federal organizations, in order to effectively plan, coordinate, and manage acquisitions in support of JPM-CBMS organizational missions. • Requirements: MBA and Science Background / Clearable for Secret Clearance ]]>

<![CDATA[Title: Call Center Nurse Job Description: - Fulfill the primary clinical communication role between the Company and the care providers and members/patients of clients of the Company; - Complete telephonic health risk assessments that facilitate patient stratification and the identification of appropriate evidence-based interventions designed to improve patient health outcomes; - Based upon ongoing reviews of accumulated patient information, implement interventions and services according to pre-established protocols and care plan guidelines designed to achieve chronic care program patient goals; - Communicate professionally with patients, providers, and caregivers to obtain or provide information, including completing telephonic health counseling and education calls; - Appropriately document all relevant information regarding patients and providers; - Adhere to all confidentiality and HIPAA requirements as outlined within Operating Policies and Procedures in all ways and at all times with respect to any aspect of the data handled or services rendered in the undertaking of the position; and Job Requirements: - Registered Nurse (RN) - Familiarity with chronic care or disease management programs; - Demonstrated phone communication experience; - Ability to manage and meet deadlines; - Highly computer literate and detail oriented; - Professionally skilled in personal presentation, verbal, and written communication; and - Meticulous organizational skills To be considered for this position please contact: Matthew Teeters mteeters@aerotek.com 410.567.8019 ]]>

<![CDATA[My clients have asked me to work on a handful of QC Mgr roles for Biotech companies both in MD and PA. Candidates must have a background in biologics. Very good opportunities with solid companies. Please feel free to send me your resume for consideration. I look forward to hearing from you]]>

<![CDATA[ATHENA Consulting (www.athenaconsultingllc.com) is recruiting for multiple RESEARCH SCIENTISTS to service specialized medical research contracts in the metro Baltimore and Washington, D.C. areas. These positions will primarily be conducting clinical research for U.S. Army Medical Research and Materiel Command. USAMRMC is the Army's medical materiel developer, with responsibility for medical research, development, and acquisition and medical logistics management. ATHENA, a certified Small Business and certified MBE, is an experienced provider of Healthcare, Scientific, IT solutions and staff augmentation to public and private sector clients. In 2009 Athena won Maryland’s Top 100 MBE and the Gazette’s PB53 award. Come join our award winning team! APPLY TO HR@ATHENACONSULTINGLLC.COM THE POSITION(S) The successful candidate will work with teams of innovative scientists to research and investigate underlying basis of health and disease, conduct clinical research, investigate methods of prevention, diagnosis and treatment of human disorders and perform groundbreaking research in expanding areas. RESPONSIBILITIES: • Perform research and collaborate in a team environment to support the Medical Infectious Diseases Research Program. • Work involves the performance of microbiological and immunological studies designed to correlate various aspects of the immune responses to bacterial and viral infections with protection in the hosts. • Require proficiency in a number of laboratory procedures including but not limited to isolation and purification of native and recombinant antigens, serum and cell separation, radioimmunoprecipitation, and opsonization assay. • Research and develop new tools to facilitate the research process. • Apply image processing and pattern recognition skills to solve complex problems. • Possible mentoring and tasking of engineering co-ops. • Document and maintain records of changes and code revisions. • Survey and gain understanding of the current market topology. • Gain understanding of and explore areas for intellectual property, providing support for the development of such. REQUIREMENTS: • Ph.D. / Masters degree highly desired; Bachelors required in biology, chemistry, physiology, physics, microbiology, zoology, parasitology, pharmacology or biochemistry, Biomedical Engineering, Imaging Science, Physics or equivalent required. • Strong understanding image processing, pattern recognition, machine learning. • 3+ years algorithmic research/development experience (1+ in corporate environment) in Image Analysis and Pattern Recognition. • 2+ years experience with MATLAB. • 3+ years of C/C++/C# programming. • Excellent technical and analytical ability with excellent problem solving skills. • Applicant must have a positive attitude and be a team player with exceptionally good interpersonal skills and ability to communicate with highly specialized research and development scientists, engineers and marketing people is a must. • Excellent verbal and written communication skills. LOCATION: These positions will be located at Ft. Meade, Ft. Dietrich, College Park, Maryland and NIH locations in Maryland. To apply for this position please email your resume in Word (.doc) version to ITJobs@athenaconsultingllc.com with a cover letter that includes your salary requirements and summary of your experience. Please do NOT call our office. ATHENA Consulting (www.athenaconsultingllc.com is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law. ]]>

<![CDATA[Discovery Solutions, Inc., a provider of scientific and technical staffing services, is currently seeking highly motivated, career-oriented individual for an opportunity as an entry-level recruiter in our Abingdon, MD office. The Recruiter will have the following responsibilities: - Utilizing recruiting techniques to identify qualified candidates through various recruiting tools. - Evaluating job candidates strengths compared with clients requirements. - Negotiating wage rates and other terms and conditions of employment with the candidates, and gain commitment from candidates for current and future job requirements. - Completing necessary pre-employment processes including reference checks and background/drug tests. - Managing contract employees while on assignment. - Working with Account Managers to identify top accounts, target skill sets, key market segments, and to assess clients staffing requirements. - Maintaining relationships with industry contacts to provide customer service, gain industry knowledge, and get referrals and sales leads. - Conduct business development activities to build personal client base. - Maintain familiarity with the most effective recruiting tools appropriate to the industry to include: networking with active consultants, constructing availability lists, database searches, Internet searches, resume searches, other job boards, and organizations. Qualified candidates for the Recruiter position must: - Have a Bachelors degree or equivalent experience, scientific background a plus. - Be available to work before/after typical office hours as work may demand. - Possess strong written and oral English communication skills. - Strong skills in social networking - Be familiar with Microsoft Word and MS Outlook ]]>

<![CDATA[Outstanding opportunity for a bright, career minded individual with college chemistry (degree preferred) along with previous experience working within a chemical related manufacturing environment. This is your "foot in the door" to one of Maryland's most well established (in business since 1898) and highly respected corporations. Learn the manufacturing process to gain ultimate growth down the road. Excellent salary, benefits and other perks offered. Hours Monday thru Friday 7:00am to 4:00pm. Don't let this one pass you by........ Contact Toni Catterton at (443) 725-5398 for more information. For immediate response, fax (410) 668-6904 or email: toni@pronetworkgroup.com your resume. ]]>

<![CDATA[Position: Laboratory Technician Location: Baltimore, MD Salary: Negotiable Terms: Contract JOB DESCRIPTION: Required to work within a team developing molecular diagnostic assays for an automated platform. DUTIES AND RESPONSIBILITIES: • Apply laboratory skills and experience in molecular biology to meet specific objectives and solve problems. • Coordinate the collection and inventory of clinical specimens. Log and track specimens using an established database. • Under moderate supervision, coordinate and conduct stability testing of specimens and assay reagents, analyze and interpret results and/or troubleshoot problems. • Collect, record, report and present results to peers and supervisor/manager either orally or in writing. • Follow standard operating, manufacturing and test procedures associated with the manufacture and qualification of assay reagents. • Interact with other Research and Development (R&D) scientists to solve problems and provide support to other functional groups. MINIMUM QUALIFICATIONS: KNOWLEDGE AND SKILLS: • Exquisite laboratory skills, attention to detail and a history of self-motivation and work within a team environment are essential. • Proficiency is required in a range of techniques in molecular biology including nucleic acid isolation/purification, hybridization-based detection and real-time PCR. Experience in the design and optimization of PCR systems and with automated liquid handling systems is desirable. • Experience in processing of infectious biological samples for the recovery of nucleic acids together with a strong background in microbiology, virology and/or clinical laboratory science is advantageous. • Knowledge of Current Good Manufacturing Practices and product development is desirable. • Excellent verbal and written communication skills are necessary. EDUCATION AND EXPERIENCE: • Bachelor’s or Master’s Degree in Life Sciences • Minimum of 1 year of laboratory experience in molecular biology. ]]>

<![CDATA[ Study By App, LLC is looking for a chemistry or calculus professional to develop core content test questions and supporting chapters for an iPhone/iTouch app. Your job would be to create around 500 unique test questions with review material. Our applications take from 150 to 200 hours to develop. We focus on nation wide tests such as the AP exams. Feel free to review our web page at www.studybyapp.com.]]>

<![CDATA[Research Associate Critical Reagents Group Gaithersburg, MD Responsibilities: • Laboratory position validating antibodies and standards plus optimizing reagent handling, integrity and uniformity with supervision. • Completes appropriate documentation to support procedures including data capture, forms, logbooks, and inventory batch records • Communicates issues/problems and results that may impact timelines, accuracy and reliability of laboratory data. • Prepares, maintains and reports reagent inventories for assigned methods, and places material requisitions. Qualifications: • B.S. Degree, preferably in the life sciences, cellular and molecular biology, or protein sciences. • The ideal candidate will have experience processing and/or characterizing proteins and antibodies. • Experience working with small and large-scale antibody purification in an industrial setting is a plus. • Other desired (but not required) skills would include- working with protein gels, western blotting, protein labeling/tagging with small molecules, spin column purifications, protein characterization methods. • Strong verbal communication skills, candidate must possess excellent interpersonal skills and have ability to work well with personnel at all levels. • Familiarity with SharePoint (end user minimum is a plus), Microsoft Excel, and electronic file management is necessary. • The candidate must possess the ability to work independently with accuracy, attention to detail, flexibility, and excel in a fast-paced, deadline-driven environment. ]]>

<![CDATA[Assoc Scientist II/ Scientist I Gaithersburg, MD Research and Development Department Summary: • Purpose of this position is to support the research and/or design and development of new diagnostic assays. • This position is almost exclusively a hand-on laboratory-based position. • Has knowledge of commonly used concepts, practices, and procedures within relevant fields. • Execution of duties relies on instruction from the supervisor and pre-established guidelines. • Initiative is required to develop a working knowledge of experimental design, technical proficiency in the laboratory, and an ability to troubleshoot experiments with assistance. • Responsible for routine production of reagents and operation of equipment. • There is a focus on building laboratory skills and conducting routine experiments. • Career development involves work toward increasing technical knowledge and skills to understand the theory behind protocols in a team environment. To do this, the position has the ability to apply a textbook knowledge of scientific principles to achieve technical objectives and prepare technical documentation at a basic level. Primary Responsibilities: • Maintain a laboratory Notebook or systems documentation • Learn and follow all safety procedures • Write monthly reports • Supports general laboratory maintenance including materials inventory and instrument upkeep • Work in the biological or instrumentation laboratory Requirements: • A Bachelors degree (B.A, B.S. or equivalent) within the applicable field, preferably Biological or Chemical Sciences is required. • Employee can also qualify with a BS or BA degree in Information Systems, Engineering (mechanical, chemical, structural, or Computer), or related field with applicable experience. • Familiar with proper use and maintenance of common lab equipment such as balances, centrifuges, pH meters and equipment commonly used in molecular biology. • Increasingly able to utilize equipment required for experiments related to research, design and development activities such as QIAGEN hc2 ver2 equipment and RCS and related software. General knowledge of MS Professional Suite programs such as Word, Excel and Outlook. • Ability for entering data in spread sheets and basic presentation and analysis. • Ability to create tables in formats used in presentations such as laboratory notebooks and monthly reports. • Ability to communicate experimental results orally and written. • Ability to interact with team members and function at a level that will encourage and foster technical discussions. • Ability to write clearly and effectively and to articulate scientific data in a laboratory notebook. • Ability to accurately perform mathematical calculations for preparing laboratory reagents (that have precise concentrations, pH, buffering capacity, conductivity, etc) and conducting appropriate experiments to assess the performance of these reagents. • Must be able to understand the underlying data sufficiently to compile, and summarize scientific data employing, tables, figures, and relevant illustrations. • Must have basic skills in arithmetic and computer usage for determining, useful values such as means, medians, ratios, confidence intervals, %CVs, regression lines, quartiles, limits of detection, sensitivity, specificity and predictive values. • A moderate level of proficiency is required in the use of computer programs for writing reports, organizing and manipulating spreadsheets of data and performing appropriate calculations on the data. • A moderate level of assistance from the supervisor or other mentors to attain mastery of the required analytical techniques is considered acceptable. • Recognize and mitigate anomalies and deviations such as malfunctioning or not maintained/calibrated equipment, expired materials or reagents, unusual appearing reagents or materials (smell, color, viscosity, and other characteristics), errors in experimental protocols pertaining to logic, layout or calculations or safety risk during routine laboratory procedures and notify supervisor. ]]>

<![CDATA[Position: Clinical Monitor/ Marketing Assistant Location: Burtonsville, MD Salary: Negotiable Terms: Permanent/Full-Time REQUIREMENTS: • B.S. in Biology, Chemistry or related field • 2+ years experience in clinical monitoring required. • Site monitoring experience required. • Training in and demonstrated understanding of the regulatory obligations of the clinical site monitor; CCRA or SOCRA CCRP certification desirable. • Self-motivated and detail-oriented. • Excellent verbal and written communication skills. • Ability to work independently, as well as in a complex team environment. RESPONSIBILITIES: Clinical Monitor • Possesses detailed knowledge of the study protocol and its associated activities and timelines. • Conducts site visits of ongoing clinical studies traveling required at least 20% • Participates in the preparation and/or review of protocols, case report forms, and informed consent documents. • Reviews, contributes to, and processes project documents and required reports, such as study protocol documents and consent forms, SAE and protocol deviation reports, accrual and other study status and/or study web site reports. • Contributes to project-specific site initiation activities, tracks readiness status of sites for study initiation, (e.g., submission of essential documents, writes and distributes corresponding internal reports). • Conducts site assessments, including site activation, interim monitoring and close-out visits. Writes and distributes site visit reports within established timelines, and tracks resolution of outstanding issues. • Collects, reviews and maintains regulatory documents pertaining to clinical trials. Review includes assessment of completeness and compliance with regulatory requirements. • Generates queries, produces and distributes anomaly reports and resolves data discrepancies. • Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs. • Maintains documentation required by corporate and project SOPs. • Attends and participates in project and functional area meetings and continuing education. • Performs data entry as necessary. • Communicates and coordinates effectively with internal and external clients and colleagues. RESPONSIBILITIES: Marketing Assistant • Prepares marketing material to be mailed to in the field sales representatives and/or potential customers and clients. • Assists in preparing and training of marketing personal. • Organizes and prepares medical marketing meeting, such as (travel arrangements, shipping of booth displays, preparing the booth for the meeting). • Collect marketing information and enters into a database. • Reviews and proofreads marketing materials (documents, ads, emails) ]]>

<![CDATA[Education and Experience: • B.S. in Chemistry or related science plus 10 or more years experience in a pharmaceutical or biotech laboratory OR • M.S. in Chemistry or related science plus 8 or more years experience in a pharmaceutical or biotech laboratory OR • Ph.D. in Chemistry or related science plus at least 6 years experience in a pharmaceutical or biotech laboratory • 5 years management experience in the pharmaceutical, biotech or analytical contract laboratory industries. Management experience should include stability/QC/analytical R&D/ project and program management, direct supervision of technical staff, and direction of laboratory operations and implementation of process and system improvements • Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Knowledge, Skills and Abilities: • Full understanding of cGMP requirements, & client SOPs, ICH guidelines, USP requirements and FDA guidance • Full understanding and knowledge of separation science and general chemistry • Proven technical troubleshooting and problem solving abilities • Effective technical writing skills • Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment • Ability to implement quality systems and process improvements • Ability to provide guidance to clients on analytical issues and regulatory requirements • Understanding of budgeting, revenue projections and other financial terms and definitions at it applies to the business • Supervisory skills in resource allocation, hiring and recruiting and other related functions • Leadership skills especially interpersonal and communication skills • Proven ability to cope with a dynamic work environment ]]>

<![CDATA[Cangene Biopharma Inc. is based in Baltimore, Maryland and has over 20 years experience providing manufacturing services to the biopharmaceutical industry. Cangene Biopharma Inc.. is a dedicated contract manufacturer focused on formulation, filling and packaging of injectable biologics, drugs and devices. We have an exciting opportunity for the right candidate to join our team in a rapidly growing environment as a Microbiologist. Essential Duties and Responsibilities: • Perform various microbiological testing procedures as per manufacturing/Quality Control batch records, Stability Protocols, raw material requests for testing, etc. • Work with Project Managers and QA to ensure timely testing and release of samples. • Inform supervisor upon observing OOS, OOL, or generation of deviations • Participate in investigations of OOS results and other related studies. • Participate in calibration, troubleshooting various types of equipment including proactive resolution of instrument issues. • Investigate and suggest new laboratory procedures/techniques. • Validate and implement new laboratory procedures/techniques. • Update existing or write new testing standards, and standard operating procedures. • Train Microbiologist I & II in methods and techniques • Write protocols and reports as necessary. • Write and review SOP’s and Testing Standards as necessary. • Review, analyze, interpret and report data. • Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures. Desired Minimum Qualifications Education and Experience: Education: BS in Microbiology/Biology or related field Experience: Minimum 2-5 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes. NOTE: Any equivalent combination of education and experience will be considered. ]]>

<![CDATA[I'm in need of a microbiology tutor for this current semester. I'll pay for the tutoring service and I ask for someone whose extremely knowledgeable and very helpful of this course. Please do reply by email. I don't require a lot of hours. Thanks]]>

<![CDATA[This is a Contract to Direct Position Quality Technician- ESSENTIAL FUNCTIONS: · Ensure quality control functions are performed according to written Standard Operating Procedures and GMP. · Assist with the facility training of employees, annual updates and other required instruction as needed. Programs include but are not limited to, blood borne pathogens, lock-out tag-out, right to know and evacuation procedures. · Assist with the maintenance of the Medical Device Records log; distribution and control of all related documents. · Maintain sterility release records and coordinate release of individual loads and disposable accessory packs. · Assist with the product complaint program as directed by the Q. A. Supervisor. · Responsible for in-process inspections, instrument inspection, dispositioning of components and product audits as directed by the Q. A. Supervisor. · Audit job performances to ensure SOP/GMP compliance. · Assist with bio-burden and airborne environmental sampling. · Other duties as assigned EXPERIENCE: Minimum of 2 years of quality assurance or quality control training and/or experience required. EDUCATION: High school diploma or GED required. Two-year Degree preferred. KNOWLEDGE, SKILLS, ABILITIES: · Must be detailed-oriented. · Verbal ability to assertively interact with all levels of personnel including senior management on quality matters. · Ability to manage time and work with minimal supervision · Well organized with ability to maintain precise records. · Knowledge of computer programs, word processing and spreadsheet · Excellent written communication skills · Ability to read and understand all Standard Operating Procedures. · Flexible in work hours Please send resumes in word format to Christopher.Wilkins@adeccona.com ]]>

<![CDATA[The Laboratory Manager oversees the operation of the Repository and the BioProcessing Divisions of the Genetic Resources Core Facility Cell Center. He/she will follow a defined set of SOPs and Best Practices as per the international standards of biological repositories (ISBR). Specifically, the manager should be well versed in database management, quality control, technical training, inventory management, and maintaining a working environment for technical success. He/she will oversee a $350,000 operating budget, 4 technicians and a biorepository with over 250,000 viable cell lines. Requirements Master’s or Ph.D. degree, with related graduate research, is preferred. Bachelor’s degree in biology, chemistry, or related field is required plus five years laboratory experience performing relevant techniques is required. A working knowledge of biology, cell culture, microbiology, and chemistry, and GLP-level documentation is preferred. CLIA-lab management skills is helpful but not required. Certification in Biosafety, Bloodborne Pathogens, and Shipping of BioSpecimens is required within first 90 days of hire. GLP certification and/or ISBR membership is a plus. We are looking for an outgoing, highly motivated person who understands the importance of quality control, is meticulously neat and organized, is well versed with databases, has the ability to follow detailed standard operating procedures, has confidence with employees and clients, has planning skills, and has the ability to motivate others. We offer a comprehensive salary program and excellent benefits, including tuition remission at the University, in a smoke/drug free workplace. For a complete job description, please visit our website: <a href="https://hrnt.jhu.edu/jhujobs" rel="nofollow">https://hrnt.jhu.edu/jhujobs</a> Johns Hopkins University is an equal opportunity/affirmative action employer committed to recruiting, supporting, and fostering a diverse community of outstanding faculty, staff, and students. All applicants who share this goal are encouraged to apply. The successful candidate(s) for this position will be subject to a pre-employment background check. EOE/AA/D/V. Qualified applicants should apply on line for position #41850 . ]]>

<![CDATA[Position: Quality Assurance Systems Manager Location: Annapolis, MD Salary: Negotiable Terms: Contract-to-Hire SUMMARY: This position is responsible for the management of Quality Systems and facilitate risk analysis, problem solving, and process improvement. Additional responsibilities include change document control, management, internal audits and the corporate training program. The Quality Systems Manager will be responsible for the development or revision of corporate procedures, policies, guidelines and training to ensure compliance with U.S. FDA current Good Manufacturing Practices (cGMP). RESPONSIBILITIES: • Manage, oversee, improve and train on Quality Systems including, documentation, deviation management, CAPA, change control, internal audits training and record management in compliance and accordance to GxP regulations. • Write and revise SOPs and processes related to Quality. • Identify training needs and provide training for end users. • Review, edit and revise various aspects of company quality management system. • Assists with quality system audits and requests for corrective actions. • Participate in regulatory inspections. • Monitor performance by gathering relevant data, writing and producing reports on the performance of the Quality System for review and as a basis for improvement of the Quality System. • Plan, hire, and manage Quality Systems staff in accordance to company policies and applicable laws. REQUIREMENTS: • B.S. in Biology, Chemistry or a related field. • 7+ years of experience in Quality Assurance within the Biotech or Pharma industry. • 7+ years specifically in Documentation Management and Training. • Experience in training Management. • 3+ years minimum management/supervisory experience • Proficiency in other compliance disciplines, i.e., cGMP, GLPs, GDP, GxPs • Biotechnology or Pharmaceutical background with Document Control and/or Document Management. • Excellent organizational and analytical skills. • Excellent written and verbal communication skills. • Experience with Microsoft based applications, and ability to learn internal computer systems. • Strong understanding of and ability to apply knowledge of regulatory requirements related to record management including archival of records. ]]>

<![CDATA[Clinical Research Associate - Clinical Monitoring Experience Needed! (217112-052) Clinical Research Associate Grifols has been a leader in the healthcare industry since 1940 by creating innovative products and services based on the values of ethics, quality and responsibility. Grifols’ focus and mission is to fulfill the needs of its patients, as well as healthcare professionals working in therapeutics, pharmacy, diagnostics and blood banking. For more than 60 years, Grifols has developed, manufactured and marketed products designed to improve human health. At our Los Angeles facility, Grifols manufactures plasma derived biopharmaceutical products of proven efficacy, quality and safety. The Grifols family of companies includes Grifols Inc., Grifols USA, Grifols Biologicals, Biomat USA and Plasma Collection Center, Inc. Grifols Biologicals researches, develops and produces therapeutic proteins from human plasma and uses the most cutting-edge technology for protein purification. Our modern facilities are organized according to Good Manufacturing Practices (GMP) and have been certified under the FDA Establishment License. This division of our company has an immediate opening for a Clinical Research Associate, offering competitive salary, along with an excellent benefits package, including medical, dental, vision, 401(K) plan, life insurance, educational assistance, and five (5) weeks of paid time off. Position Summary: <ul> <li>The Clinical Research Associate performs and coordinates all aspects of the clinical monitoring process in accordance with Good Clinical Practices (GCPs) and global SOPs to assess the safety and efficacy of investigational products and/or medical devices. In addition, Clinical Research Associate can be involved in the process of submission and application of the proper clinical documents (protocol, informed consent form, patient information sheet and the like) to IRBs, sites and authorities during the start-up period. Also, Clinical Research Associate represents Grifols in the medical research community and develops collaborative relationships with investigative sites and vendor personnel, including CROs. Position may require some travel.</li> </ul> Job Responsibilities: (include the following. Other duties may be assigned) <ul> <li>Monitor clinical sites as needed to ensure GCPs and complete the monitoring reports.</li> <li>Provide help as needed to the clinical sites to assist them with carrying out the protocol.</li> <li>Assist with documentation control and regulatory requirements.</li> </ul> Skills/Experience, Qualifications, and Education Requirements: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions). <ul> <li>Minimum of a 4 year Bachelor’s degree in life sciences or related field.</li> <li>Minimum of 5-7 years experience as an on-site clinical monitor</li> <li>Previous Study Coordination is highly preferred</li> <li>Demonstrated clinical monitoring skills</li> <li>Therapeutic experience in Hematology, Immunology, Phase II-IV trials a plus</li> <li>Ability to attain and maintain a working knowledge of GCPs and applicable SOPs</li> <li>Thorough understanding of medical terminology </li> <li>Excellent computer skills, with ability to learn and become proficient with necessary software</li> <li>Excellent oral and written communication skills </li> <li>Strong interpersonal and communication skills with ability to interact with all levels of personnel in a professional manner.</li> <li>Highly motivated, self-starter who can work independently and also work in a team-oriented environment. </li> <li>Ability to manage multiple projects simultaneously, resolve problems, and meet deadlines.</li> <li>Strong client and customer service skills</li> <li>Demonstrated attention to detail</li> <li>Demonstrated flexibility and adaptability</li> <li>Willingness to travel up to approximately 40%.</li> </ul> APPLY VIA URL: <a href="http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=217112&company_id=16052&jobboardid=550" rel="nofollow">http://hostedjobs.openhire.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=217112&company_id=16052&jobboardid=550</a>]]>