Associate Director/Director - Upstream Process Development

Associate Director/Director of Upstream Process Development
Greater Boston Area
Onsite

Job Summary:

The Associate Director/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. This position is 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.
• Travel 20-25% in support of manufacturing activities at 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.