Scientist II, Upstream Process Development

Celgene

(Summit, New Jersey)
Full Time Travel Required
Job Posting Details
About Celgene
Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.
Summary
This scientist II position in Biologics Process Development is to develop high-performance upstream processes for recombinant protein production. Reporting to the head of Upstream Process Development Group, the successful candidate should have a strong scientific background to build an efficient platform for robust upstream processes. The candidate will also work closely with various partners such as Cell Line Development, Downstream Process development, analytical development, formulation development, Discovery and CMOs to meet project objectives such as fast tox material generation and successful cGMP manufacturing campaigns.
Responsibilities
* Using a systematic approach to develop robust upstream processes, and to ensure scale-up and technology transfer to clinical manufacturing. * Leading the development of in-house platform media for multiple cell lines to reach high productivity * Collaborating closely with the cell line development group on clone selection and platform adaptation or improvement * Investigating the impact of raw material, cellular metabolism, and process parameters on the product quality, and to develop a strategy for IP protection * Providing prompt technical support for solving real-time manufacturing issues as well as necessary SME assessment for deviation investigation * Managing upstream related CMC activities to meet aggressive timelines and requirements for fast-to-FIH clinical supply * Staying current with industry standards, trends, new technical developments, and all applicable regulations and guidances * Writing technical summary and development reports for efficient knowledge management and regulatory filing support Publishing or presenting scientific findings in peer-reviewed journals or conferences, and contributing to industrial collaborations
Ideal Candidate
**Qualifications:** * Ph.D. in Chemical Engineering or related fields with 3- 5 years of industry experience. **Skills/Knowledge Required:** * Ph.D. in chemical engineering, biochemistry, or appropriate technical discipline * 3-5 years of industrial bioprocess experience with a proven track record of accomplishment in the design, development, and implementation of bioreactor cell culture processes * Hands on experience with upstream development activities at various scales including media preparation, inoculum expansion, and bioreactor operation * Familiarity with bioreactor engineering systems including both equipment hardware and automation control principles * Knowledge of cell biology, protein expression, and cell metabolism pathway * Strong background in mathematic modeling and statistical analysis. * Demonstrated ability to collaborate effectively within a team setting as well as with external partners. * Excellent verbal and written communication skills with a proven record on publications and presentation in scientific forums * Excellent organizational and time management skillsc
Compensation and Working Conditions
Reports to Head of Upstream Process Development Group

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