Associate Director, Upstream Biologics Drug Substance

POSITION OVERVIEW:

Reporting to the Executive Director, Biologics Drug Substance (BDS), the Associate Director (AD) Upstream BDS will be an integral member of the BDS group. The AD BDS will be responsible for leading the design, optimization, and scale-up of upstream processes, with a focus on antibodies and proteins, across early and late development stages. This individual will play a critical role in transferring upstream processes to manufacturing sites, supporting process characterization, validation, and regulatory filings. The ideal candidate combines strong scientific expertise, leadership in CMC development, and practical experience collaborating 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 — 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, as appropriate, to proactively identify technical risks and provide scientific recommendations for mitigation plans.
• Contribute to a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement.

 REQUIREMENTS:

• A degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline with 8+ years of relevant industry experience. MS or PhD is preferred.
• Proven track record in upstream development and manufacturing of monoclonal antibodies, including both 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%.