Associate Director, Upstream Biologics Drug Substance

Role Summary

Associate Director, Upstream Biologics Drug Substance. Hybrid role with remote work and headquarters in Watertown, MA.

Reporting to the Executive Director, Biologics Drug Substance, the Associate Director will lead design, optimization, and scale-up of upstream processes for antibodies and proteins across early and late development, transfer processes to manufacturing sites, and support process characterization, validation, and regulatory filings. The role requires strong scientific expertise, leadership in CMC development, and collaboration with CDMOs and internal stakeholders.

Responsibilities

• Lead upstream process development for biologic programs from preclinical through late-stage development, ensuring scalability, robustness, and product quality.
• Oversee cell line development, media/feed optimization, bioreactor scale-up, and process parameter definition.
• Lead tech transfer to CDMO manufacturing sites, ensuring successful execution at pilot and large scale.
• Design and direct studies for process characterization, process performance qualification (PPQ), and technology transfer.
• Author and review key development reports, risk assessments, and regulatory submission documents (IND, IMPD, BLA).
• Partner with analytical, downstream, and manufacturing sciences teams to ensure seamless integration of drug substance activities.
• Support CDMO selection, oversight, and technical governance ‚Äî including remote and on-site presence as required (approximately 25% travel).
• Lead troubleshooting and deviation investigations for upstream operations.
• Contribute to defining process control strategies and lifecycle management plans in alignment with relevant guidelines.
• Foster technical excellence and innovation within the upstream development team.
• Ensure compliance with company and regulatory standards for documentation, data integrity, and safety.
• Engage with CMC and/or Executive Leadership to proactively identify technical risks and provide scientific recommendations for mitigation plans.
• Contribute to a positive workplace culture that prioritizes collaboration, accountability, and continuous improvement.

Qualifications

• A degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline with 8+ years of relevant industry experience. MS or PhD preferred.
• Proven track record in upstream development and manufacturing of monoclonal antibodies, including early (Phase 1/2) and late-stage (Phase 3/commercial) programs.
• Hands-on experience with mammalian cell culture systems (CHO, NS0, etc.), fed-batch and/or perfusion processes.
• Strong understanding of process scale-up, tech transfer, and process validation principles.
• Experience working with CDMOs or external partners in development and GMP manufacturing settings.
• Familiarity with Quality by Design (QbD), DoE, and statistical data analysis tools.
• Hands-on experience supporting regulatory filings.
• Working knowledge of relevant regulatory guidance (ICH, FDA, EMA) for biologics development.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Ability to travel domestically and internationally up to 25%.

Skills

• Upstream process development
• Cell line development and bioreactor scale-up
• Tech transfer and process validation
• Regulatory documentation and filings
• Cross-functional collaboration
• Quality by Design, DoE, statistical analysis

Education

• Bachelor‚Äôs degree required; advanced degree preferred (MS/PhD)

Additional Requirements

• Up to 25% travel domestically and internationally