Candidate Profile
The successful candidate will have a strong scientific background, as well as hands-on expertise establishing and debugging cell culture procedures for protein-based biologic products. In order to design scalable, robust, and effective procedures, the candidate must also have experience scaling up/down, tech transfer, and a thorough understanding of cGMP.
Key Responsibilities:
- On the Protein Discovery team, serve as the upstream process (USP) development subject matter expert. Develop procedures and documents such as batch records, summary reports, and technical reports.
- Design and carry out experiments, as well as gather and analyze data. In a timely manner, present process analyses, trends, and summaries to the group.
- Generate, enhance and enrich process understanding knowledge. Initiate novel process/technology when applicable.
- Assist with DSP work as necessary.
- Make strong technical contributions to cross functional development project teams to ensure efficient and timely execution of deliverable.
- Collaborate with other teams and CDMO partners in designing manufacturing processes and assist with tech transfer activities.
- Contribute to relevant sections of IND filings and other documentation.
Requirements:
- A bachelor's degree in a relevant field of study with at least ten years of industry experience, a master's degree in an applicable subject of study with at least eight years of industry experience, or a doctorate in an applicable field of study with at least five years of industry experience.
- Demonstrated ability to design and troubleshooting cell culture methods.
- The successful applicant will be knowledgeable in all USP unit operations and related software, including aseptic operations, CO2 shakers, bioreactors, and filtration apparatus. USP related process analytics experience in cell growth and metabolites analysis.
- Ambr system and/or DasGip experience.
- Experience with Fc fusion proteins, as well as monoclonal antibodies, is strongly preferred.
- DOE experience is strongly preferred.
- Experience with statistical software such as JMP or Minitab.
- Understanding of QbD is a plus.
- DSP experience or knowledge is a plus.
- cGMP collaboration experience preferred including experience in technical reviewing.
- Strong desire and interest in developing a novel therapeutic protein class.
