Director of Upstream Process Development
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, QA/QC, 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.
