Associate Scientist, GTx Upstream Development

Pfizer Inc. - Morrisville, NC

The Gene Therapy area of the Bioprocess R&D department is responsible for the development of GMP manufacturing processes for our gene therapy products. As a member of the Bioprocess R&D development department, the Associate Scientist in Upstream process development is responsible for executing mammalian cell bioreactor experiments in bench-top bioreactors and associated scale-down equipment with the goal of developing robust, scalable, and high productivity processes that produce viral vectors with the appropriate product quality to treat human disease. The work will also involve working with pilot scale, commercial and clinical production facilities to ensure accurate technology transfer and successful large-scale production.

The successful Senior Associate Scientist applicant will have experience in laboratory research, and a desire to continue in a laboratory-focused role. This position will join a larger team of scientists across multiple sites focused on developing and optimizing cell culture processes for recombinant viral vectors for early- and late-phase clinical trials. The Associate Scientist will be responsible for working with fellow scientists to develop robust, efficient, scalable strategies for improving upstream process performance. The job function requires judgment and innovation to achieve a solution within standard practices and procedures. Responsibilities will include conducting experiments and tests as part of a variety of research and development activities, e.g., small-scale studies, pilot plant and manufacturing upstream studies. The Associate Scientist will be expected to summarize, evaluate the study results, and test new hypotheses to improve the fundamental understanding of upstream cell culture processes. This position will support process validation, quality by design, and regulatory approaches. This position will be expected to prepare internally reviewed technical reports, and make oral presentations to scientists and management. The successful candidate must be able to endorse change to business infrastructure to ensure pipeline, legacy and technology success.

Specific Roles:
Execute mammalian cell culture experiments with the goal of developing scalable productive processes for viral vectors with appropriate product quality attributes for clinical applications
Utilize shake flasks, single use bioreactors and bench top stirred tank bioreactors for cell growth
Perform analytical methods to monitor cell growth, metabolites, and analyze productivity of cultures.
Prepare samples for analysis for both internal and external shipment to outside laboratories
Communicate experimental results both orally and in written reports
Record laboratory data in accordance Pfizer's policy's
Operate support equipment such as autoclaves and incubators
Complete Pfizer's corporate training programs as required
Follow all Pfizer safety programs

BS with 0-3+ of cell culture experience in a laboratory setting preferably in process development of biotherapeutics
Basic skills include aseptic technique, cell counting, culturing mammalian cell lines in shake flasks and/or bioreactors, thawing and freezing cell lines, and determination of cell culture metabolites
Ability to execute detailed experimental plans, record procedures, and analyze data
Demonstrated ability to drive for results and generate innovative solutions with minimum supervision.
Applicants should be self-motivated, organized, capable of working independently and in a collaborative environment.
The successful candidate will possess strong oral and written communication skills and strong attention to detail
Training should include essential laboratory skills; i.e. operation of a pH meter, microscope, incubator, balances, pipetting, filtration, centrifuges, spectrophotometers and working in a biological safety cabinet
Mechanical aptitude with respect to laboratory equipment and sample processing
Ability to learn new procedures and work with computerized process control equipment
Willing to expand scientific skills and accept direction from senior staff members
Takes the initiative to solve scientific problems and contribute to their resolution
Able to work in a fast paced team environment with changing priorities

Experience in transferring biotherapeutic processes to pilot plants or manufacturing organizations, and knowledge of data acquisition and controls systems in these environments is a plus.
Sound understanding of Statistical experimental design and analysis is a benefit.

Other Job Details:
Last Date to Apply for Job: May 29, 2019
Eligible for Employee Referral Bonus: Yes
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N (Other) (United States of America)
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