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<![CDATA[***Please note that this is a part time (20 hours a week) 6 month (possibly longer if needed) contract position. Candidate cannot start an assignment until background check and drug test is completed**
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Description:
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Skin Care formulation preparation. Perform stability assessment on the physical properties of the sun/skin care products using Microscope, pH, centrifuge, viscometer, rheometer and texture analyzer Data analyses for the experimental results and report writing.
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Requirements:
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A BS degree in Chemistry/physical sciences with at least 1-2 years of lab experiences in an academic or industrial setting. Good computer skills, good oral and written skills. Experience working with laboratory equipment of precision instrumentation. Ability to take directions and work with highly skilled scientists and engineers in a team environment.
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**Microscope,PH,centrifuge, formulation prepartion, rheometer]]> | <![CDATA[Sr. Process Engineer - Parenteral Products
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The Associate Sr. Consultant Engineer is a member of the Packaging Process Engineering team within the Pharmaceutical Sciences Research & Development (PSR&D) organization. PSR&D is responsible for developing pharmaceutical products for clinical trial and commercial use. The Packaging Process Engineering team is responsible for developing engineering solutions and technology to meet packaging process development challenges for new pharmaceutical products. The engineer will provide technical expertise to design, characterize and improve pharmaceutical packaging processes with emphasis on sterile products for parenteral administration..
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KEY OBJECTIVES/DELIVERABLES:
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Process Engineering:
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Lead development of packaging processes, including filling and closing, for parenteral products in R&D and clinical trials with primary focus on container closure and packaging aspects of parenteral process engineering.
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Partner with development scientists, quality and business representatives to define and characterize packaged product attributes.
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Define process control strategies for component handling, filling, closing, and secondary packaging processes.
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Identify and implement process improvements for existing processes.
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Create process documentation including process flow documents, engineering studies, and technical reports.
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Lead and/or support technology transfer activities for process implementation at clinical supply and commercial sites.
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Technical Leadership:
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Serve as a key technical resource for parenteral packaging processes for sterile products including vials, cartridges, syringes, and novel and emerging container systems and materials.
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Provide engineering technical oversight for clinical trial supply operations internally and at contract manufacturing organizations.
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Serve as subject matter expert for parenteral packaging unit operations.
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Serve as a contact for technical questions from inspectors, operations personnel, and development scientists.
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Develop networking relationships with internal and external business partners e.g. corporate engineering, equipment suppliers, contract manufacturing organizations, etc.
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Stay abreast of industry and regulatory trends and incorporate learning into engineering practices.
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Mentor others in the application of engineering principles.
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Technology Innovation:
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Support the selection and implementation of new technology solutions for the continuous improvement and optimization of existing processes.
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Address process development challenges through experimental design, execution and reporting.
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Evaluate new technologies for use in pharmaceutical packaging and R&D applications.
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Partner with development scientists and other engineers to transform processes and operations to enable development of new products.
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MINIMUM REQUIREMENTS:
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B.S or M.S. in Engineering, Science or similar, with at least 8 years process engineering experience in a product/process development, or pharmaceutical manufacturing environment; or Ph.D. in Engineering, Science or similar, with at least 5 years process engineering experience in a product/process development, or pharmaceutical manufacturing environment
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Minimum 3 years experience with parenteral product manufacturing or packaging is required.
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Knowledge of parenteral dosage forms including vials, syringes, and cartridges.
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Knowledge of parenteral equipment suppliers.
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Knowledge of process analytical technologies.
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Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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ADDITIONAL SKILLS/PREFERENCES:
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Previous experience with Clinical Trial Materials
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Previous experience working with contract manufacturing organizations (CMO's)
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Excellent leadership, interpersonal, and oral/written communication skills are required; individual must be able to respond to changing priorities and short lead times; able to identify problems and work toward solutions; able to influence without direct authority; and must be attentive to details.
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OTHER CONSIDERATIONS:
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Up to 10% travel may be required.
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Relocation is available for the right candidate.
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Please submit resume and cover letter to:
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Right Resource Management Group
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Barbara Knight
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knight3324@bellsouth.net]]> | <![CDATA[Director Parenteral Manufacturing and Technology
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This key position within the Lilly Manufacturing Science and Technology (MS&T) organization is the Director responsible for day to day management and technical leadership of the Parenteral Products NetworkCommercialization Technical Center (PPN CTC). Activities will be centered around delivering on the CTC's mission of supporting Lilly Manufacturing Sites, delivering new line extensions, and career development of staff.
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Provide supervision, coaching, mentoring, career development, and front line support for the PPN CTC staff, in partnership with SeniorDirector, Senior Research Advisor, and other senior staff.
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Where appropriate, define and deliver portfolio projects requiring CTC resources which are aligned with Network productivity and technical advancement objectives. Interacts across the globe with MS&T leadership within PPN to identify and address issues at the Sites and across PPN.
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Work closely with PPN Sites, Product Development, and other technical organizations to provide CTC commercialization support for new products and processes under development.
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In partnership with Development and Engineering, drive the exploration and implementation of new and improved technologies, seeking to replicate the best technical solutions between Sites and Development.
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Review and approve technical reports, regulatory submissions, and other technical documentation generated by CTC personnel.
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Monitor the CTC budget and participate in business planning activities. Manage resources to ensure financial and operational objectives are met in partnership with Senior Director.
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MINIMUM REQUIREMENTS:
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Ph.D. is required.
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The candidate must have a minimum of 10 years experience in the pharmaceutical or biotech industry with hands-on experience in development and manufacturing of parenteral products.
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A minimum of two years experience supervising a group of scientists in either a manufacturing or development environment is required.
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The candidate must have experience with the unit operations used in sterile product manufacturing, including for example compounding, filtration, filling, aseptic processing, and sterility assurance.
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Knowledge of parenteral container closure systems (vials, cartridges, prefilled syringes) is key.
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ADDITIONAL SKILLS/PREFERENCES:
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Prior experience with both small synthetic organic molecules as well as proteins is strongly preferred.
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Ph.D. in Pharmaceutics, Pharmaceutical Biochemistry, or Biochemical Engineering is preferred.
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An undergraduate degree in Pharmacy, Industrial Pharmacy, Biochemistry, or Biochemical Engineering is preferred.
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The ideal candidate would both manufacturing-related experience (technical support, technical transfers, validation) as well as some product development experience.
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Fluency in spoken and written English is a requirement, but fluency in French or Italian would be considered a strong additional asset. Some familiarity with solid oral dosage forms or alternate drug delivery systems would also be seen as an advantage.
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Finally, the candidate must have demonstrated strong interpersonal and communication skills and the ability to work well with diverse organizations andinternational cultures.
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The position is a full time position during normal working hours. Travel, both domestic and international, will be required (approximately 10%.)
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Relocation is available for the right candidate.
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Please submit resume and cover letter to:
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Right Resource Management Group
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Barbara Knight
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knight3324@bellsouth.net]]> | <![CDATA[Regional CRA for immediate need. As key team members supporting new drug applications, the Regional CRA is accountable for on-site clinical monitoring activities from study start-up through close-out. As specified in the monitoring plans, the RCRA will perform source document verification review of Case Report Forms, oversee drug accountability, as well as manage investigational site to ensure compliance with FDA regulations, ICH/GCP guidelines, and company SOPs.
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Requirements: Travel
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These positions are home-based and require over 50% travel
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Experience:
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For you to be the successful candidate we are looking for in these roles you must have a proven track record of monitoring clinical trials in a variety of Therapeutic Areas through the CRO or Pharmaceutical industry
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Education:
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For consideration, you must hold a Bachelor's degree, preferably in a scientific or nursing discipline Due to the precise requirements of these positions, we will only be contacting candidates that meet all of the listed criteria. If you are qualified and interested in the excellent career opportunities we have for you, please reply to this ad immediately with your CV and availability.
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]]> | <![CDATA[Translational Sciences. LLC is a new Biotech Company that translates research insights into novel therapies for stroke and cardiovascular disease. We seek a full or part-time research associate with significant laboratory experience in immunoassay techniques (e.g., monoclonal antibody testing such as immunoassay development, affinity measurements, etc.). Candidates with significant research experience in molecular biology, biochemistry, clinical laboratory techniques, etc. will also be considered. Meticulous record keeping is a requirement. Salary commensurate with experience. Please email CV to CFO, Translational Sciences LLC]]> |
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