Senior Director Upstream Process Development Biologics

Meet is partnering with a leading biopharmaceutical organization seeking a Senior Director to lead upstream process development for biologics and gene therapies. This role involves overseeing a team of scientists focused on developing and scaling mammalian cell culture processes for clinical and commercial manufacturing.

Key Responsibilities

• Drive innovation in CHO cell culture platforms for monoclonal antibody production, including media development and bioreactor optimization.
• Lead scale-up from bench to manufacturing scale, ensuring process robustness and consistency.
• Apply Design of Experiments (DOE) to optimize upstream parameters for HEK293-based viral vector production.
• Collaborate cross-functionally with downstream, analytical, regulatory, and clinical teams.
• Manage technology transfer to GMP manufacturing sites, including CDMOs.
• Support regulatory submissions (e.g., IND, BLA) with upstream process data.
• Foster a high-performing, innovative team culture with clear goals and development plans.

Qualifications

• Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or related field.
• 8–10 years of experience in upstream process development in the biopharma industry.
• Deep expertise in CHO and HEK293 expression systems, bioreactor operations, and process scale-up.
• Familiarity with automated systems like ambr250.
• Proven leadership in cross-functional environments and experience with regulatory documentation and CDMO collaboration.