Position’s focus is on cell culture/upstream process development for  all pipeline antibody products using mammalian expression systems. Responsibilities include the identification of critical process parameters, cell growth and productivity optimization using statistical and empirical approaches, and scale up of upstream process from bench and pilot-scale to large scale disposable production bioreactors. Responsibilities may also include troubleshooting established commercial antibody upstream processes or for 2^nd generation process improvement in a technical support role. The ideal candidate should have experience and knowledge in batch, fed-batch and or perfusion culture systems with full understanding of metabolic flux shifts during production.

• Develop scalable cell culture processes for production of antibodies using mammalian expression systems.
• Design, investigate, and execute experiments to explore all aspects of media, feeds, and cell culture optimization and product recovery from process streams.
• Author technical developmental reports.
• Participate in writing CMC sections for regulatory submissions.
• Lead efforts in improving current cell culture process, e.g. literature searches, vendor interactions, etc.
• Collaborate with other functional areas, including cell line development, downstream development, analytical and formulation development and manufacturing groups.
• Involve in technology transfer of antibody production process to CMOs
• Mentor junior associates

• Ph.D. in Biochemical Engineering/Chemical Engineering or related field with 2 years relevant experience or equivalent combination of education and experience; or BS/MS in Biochemical Engineering/Chemical Engineering or related field with 5+ years of relevant experience; or equivalent combination of education and experience.
• Experience in leading and motivating others within team environments.
• Must have practical experience and in-depth knowledge of state-of-the-art principles and theories in media optimization and nutrients role in fed batch fermentation.

Special skills/knowledge

• Knowledge of bioreactor hardware and controllers in intermediate-to- commercial scale (1L-2000L).

• Knowledge of cGMPs and process validation requirements desired but not required.

• Require some flexibility in work schedule ie may include working some weekend or off-shift hours to troubleshoot and/or monitor cell culture process.