Biopharmaceutical company with a robust pipeline across various stages of development for products that focus on a span of debilitating diseases that have a huge unmet need in the Life Sciences industry.
The Sr. Manager role for Upstream Process Development and Manufacturing would report directly to the Director of Upstream Process Development and Manufacturing and will be responsible for leading and supporting the upstream development responsibilities of late-stage programs (phase 3 development). The job level can be flexible based on the candidate's qualifications.
- Lead and aid upstream development and manufacturing activities of late-stage programs, such as: phase 3 process development, technology transfer, GMP manufacturing, process characterization, process validation and BLA-enabling studies.
- Lead and support technology transfer between various manufacturing sites and give on-floor support through GMP manufacturing operations.
- Cooperate with internal lab to design and apply development studies.
- Give technical input for the development and up-scaling of robust upstream processes.
- Author and review CMC documentation for regulatory filings.
- Demonstrate and maintain an understanding of current trends and emerging upstream process technologies to ensure that team is at the cutting edge of biologics development.
- Apply innovative technical ability and knowledge to analyze experimental data and results with a critical eye.
- Set distinctly defined goals to ensure delivery of high-quality results.
- Provide concise communication to productive line management and cross-functional teams with regards to progress against technical objectives/milestones.
- Ensure properly organized, clear, and complete records of all activities over areas of responsibility.
- Roughly 5-10% of local and/or international travel.
- PhD in chemistry, chemical engineering, biochemistry, or other related discipline with 3 or more years' experience, or M.S. with 5 or more years of biologics drug development experience in biotech/pharma industry.
- Experience in the areas of upstream process development and process characterization based on quality by design (QbD) principles.
- Experience in tech transfer, scale up, GMP operation process validation and BLA-enabling activities.
- Comprehension of and experience with production of recombinant proteins via mammalian cell lines.
- Experience in managing external vendors and manufacturers is an advantage.
- Comprehension of cGMP regulations.
- Experience in preparing and defending regulatory documents (BLAs/NDSs/MAAs) is a plus.
- Experience and knowledge in process validation highly desired.
- Excellent teambuilding, leadership, and management skills.