Principal Research Associate (Downstream Processing) Job Listing at Genzyme Corporation in Framingham, MA (Job ID Genzyme_feed.xml_31988)
Principal Research Associate (Downstream Processing)-31988
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Job Responsibilities/Department Description:
The Principal Research Associate, Gene Therapy Development - Downstream Processing, will execute ongoing process development activities to establish process technology for the clinical manufacturing of gene therapy products in compliance with all current regulatory and corporate quality guidelines. This individual collaborates with all supporting groups and departments to ensure technical and operational requirements are established and maintained in order to meet all relevant company, site and departmental development goals.
- Independently carry out experiments supporting the generation of a purification strategy for the production of viral gene therapy vectors. The individual will analyze/interpret results and may recommend additional experiments that expand process knowledge and improve process performance.
- Participate in process scale-up activities, including execution of manufacturing scale runs; may act as a subject matter expert supporting the transfer of process technology to both internal and external clinical manufacturing groups.
- Author protocols, technical reports, data analysis summaries, and SOP's. May contribute to the generation of regulatory filings.
- Use scientific principles and experiential knowledge to solve complex problems in creative and practical ways.
- Maintain knowledge of state-of-the art principles and theories in area of responsibility. Evaluate new technology and make recommendations to their implementation in Gene Therapy process development.
- Adheres to and supports all safety programs by ensuring personnel safety training is completed and safety equipment is available.
· Bachelor's degree and 9 years of experience or Master's and 7 years of experience
· Greater than 5 years of relevant experience in the purification of biologics.
· Must have demonstrated skills and working knowledge of the unit operations associated with biologics manufacturing - column chromatography (operation of manual and automated chromatography systems), TFF, depth filtration).
Ability to operate in a dynamic, fast-paced, safety conscious, multi-product development and manufacturing environment with shifting priorities. Strong commitment to accountability for self and departmental staff for completion of objectives in accordance with established plans.
Job : Research And Development
Primary Location : United States-Massachusetts-Framingham
Job Posting : Jan 3, 2013
Shift : Day Job
Job Type : Regular
Employee Status : Regular
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