Manager, Bioreactor Process Development

Manager, Bioreactor Process Development

Evotec

Toulouse, France

Missions and responsibilities:

• Lead a diverse group of scientists responsible for development and tech transfer of early and late-stage (characterization and validation) upstream perfusion/intensified fed-batch processes for biotherapeutics manufacturing as well as technology development projects.
• Prepare and run bench-scale bioreactors and bioreactor-related equipment (controllers, pumps, autoclaves, etc.). This may include but not limited to, build and autoclave bioreactor parts and assemblies as well as assisting with bench-scale bioreactor operations (daily sampling and analytics, inoculation activities, run preparation, and troubleshooting).
• Serve as a functional area lead for platform or complex client early-stage (FIH) and late-stage Process Characterization (PC) projects as well as technology development projects.
• Serve as an internal technical resource for cGMP manufacturing and Process Design, as well as a resource and subject matter expert for external clients and partners for cell culture and bioreactor processes (small scale models, process transfer, and scale up).
• Communicate experimental plans and data to teams and clients clearly and effectively including communicating scientific information to a diverse set of audiences, including external clients, vendors, and technology development collaborators.
• Independently design, execute, and analyze statistically designed experiments (DOE).
• Author SOPs, reports, and slides which summarize, organize, and interpret experiment results with review by appropriate team members.
• Train, mentor, and supervise junior staff and interns.
• Potential for weekend work and being on-call for critical bioreactor runs.

Knowledge, skills and abilities:

• Expertise in bioreactor cell culture and perfusion technology development and tech as well ass CMC sections authoring for regulatory filings.
• Experience in Biosimilar development.
• Experience with commercial process development, process characterization, and validation.
• Expertise in design of experiments (DOE) and statistical analysis.
• Experience with high throughput cell culture (e.g. HT assays, robotics such as Ambr systems, lab automation, or multi-omic data) is a plus.

Pluses

• Experience analyzing data in tools such as JMP, R, or Python.
• General understanding of cell biology, fluid dynamics, and biotransport as well as knowledge in other functional areas (downstream purification and analytical sciences).
• General understanding of circuits (grounding, power, signal, etc.).
• Experience working in a cGMP or clean room setting (this job is non-GMP but knowledge of GMP is helpful for process/tech transfer activities).

Experience and education:

• Master’s in engineering, Biochemistry, Biology, or related field with 8+ years of experience or Ph.D. in Engineering, Biochemistry, Biology, or related field with 6+ years of experience.
• Proficiency in both verbal and written English is essential.