Director of Upstream Process Development

Director of Upstream Process DevelopmentBoston, MA Job Summary:The Director of Upstream Process Development will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. The position will be pivotal in developing robust, scalable, and cost-efficient processes for the development of novel biologic therapeutic products.The ideal candidate will have extensive experience in bioreactor operations, cell line development, media optimization, and tech transfer. This is a hands-on leadership role with direct involvement in process development and close collaboration with downstream, analytical, and manufacturing teams.Key Responsibilities:Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement.Establish clear objectives, KPIs, and development plans for team members.Oversee the development and optimization of upstream processes, including cell culture, media development, bioreactor design, and process control strategies.Focus on high-yield, scalable processes using mammalian, microbial, or insect cell systems for biologic production.Implement robust experimental designs (DOE) to optimize parameters such as media composition, feed strategy, and culture conditions.Collaborate with cross-functional teams (e.g., downstream, analytical, QAQC, regulatory, and clinical) to ensure seamless integration of upstream processes into the overall development pipeline.Lead efforts in scaling up upstream processes from bench-scale to pilot- and manufacturing-scale, ensuring process consistency and robustness.Coordinate and manage technology transfer to internal or external GMP manufacturing facilities (CMOs), ensuring the successful implementation of processes for clinical and commercial production.Troubleshoot and resolve scale-up challenges, ensuring alignment with quality and regulatory expectations.Lead or support the preparation of relevant sections for regulatory submissions (IND, BLA, etc.).Oversee the project lifecycle, from feasibility studies to full-scale production, ensuring timely delivery and alignment with project milestones.20-25% travel in support of manufacturing activities at the CDMOs. Collaborate with cross-functional teams, including downstream development, quality assurance, regulatory affairs, and manufacturing, to ensure seamless integration and process success.Qualifications & Requirements:Master's or Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or a related field with 8 - 10 years of experience in upstream process development; with at least 5 years in a leadership role within the biopharmaceutical industry.Expertise in cell culture, fermentation, bioreactor operations (single-use and stainless steel), and process scale-up.Strong scientific background in cell line development, media optimization, and bioreactor operation.Hands-on experience with various cell culture platforms, such as CHO, HEK, microbial systems, and viral vector production.Proven track record in process characterization, validation, and regulatory submissions.Familiarity with automated process development tools and high-throughput screening technologies.Experience working with CDMOs and external manufacturing partners.

Created: 2024-11-02