Senior Director Upstream Process Development Biologics

Senior Director Upstream Process Development Biologics 172543 Posted: 14/08/2025 Salary Range: $144,000 - $250,800 USD Location: Indianapolis, United States Employment Type: Permanent 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 Degree 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. For more information, please reach out to Martin Wenzel, Senior Division Director. Share this opportunity or apply for this role.

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