- Provide technical support to Manufacturing in the investigation and resolution of problems, corrective and preventative actions (CAPAs), planned deviations, risk assessments and process changes.
- In consultation with Cell Culture Development and Cell Culture Production, collaborate to identify, propose, and execute process and procedural changes to improve process performance, robustness, productivity and efficiency.
- Participate in developing scalable cell culture and harvest processes for mammalian, insect and E. coli cell lines.
- Optimize bioreactor parameters and evaluate alternative technologies
- Work independently on defined projects for development of mammalian/insect/E. coli cell culture processes for recombinant protein and antibody production.
- Contribute substantially to the development of cell culture process improvements and efficiencies
- Proactively identify problems and troubleshoot solutions
- Troubleshoot and resolve process related problems observed at manufacturing scale via the evaluation of data from manufacturing lots.
- Perform independent data analysis and interpretation to develop strategies for optimization and troubleshooting.
- Act as a technical resource for the Process Engineering team and others across the organization, developing in-depth knowledge of cell culture processes and its impact on downstream purification processes.
- Participate in the assessment and development of new innovative technologies and enhance fundamental understanding of current processes.
- Participate in manufacturing transfers and collaboratively troubleshoot issues.
- Participate collaboratively in the scale-up activities for existing and new products.
- Support evaluation of new technologies for laboratory instrumentation.
- Foster process harmonization and workflow optimizations within the cell culture teams.
- Build and maintain effective collaborations with Manufacturing, Process Engineering, Development, Quality Assurance and Quality Control groups.
- Demonstrate breadth of knowledge in biology, biochemistry, cell culture development and operations with the ability to apply this knowledge to the design, implementation and interpretation of experiments
- PhD in a biological or engineering science with 1-3 years of industry related experience, Master’s Degree with 3-6+ years of related industry experience or Bachelor’s Degree with 8-10+ years of experience
- Demonstrated ability to work independently and collaboratively in cross-functional teams
- Demonstrated ability to leverage emerging trends in biotechnology to solve complex problems
- Strong interpersonal skills, communication skills and documentation skills are required
- Ability to generate results and perform work with minimal supervision.
- Knowledge and experience in mammalian cell culture and biotechnology related development
- Comfortable in a fast-paced, diverse environment with ability to adjust workload based upon changing priorities
- Experience with operating and optimizing bioreactor cultures, particularly for recombinant protein and monoclonal antibody production from a variety of expression systems.
- Experience working under GMP guidelines.
- Strong team player, self-motivated, and willing to learn new techniques and concepts.
- Knowledge in product transfer and manufacturing in compliance with ISO quality systems.