Associate Director, Downstream Biologics Drug Substance

POSITION OVERVIEW:

Reporting to the Executive Director, Biologics Drug Substance (BDS), the Associate Director (AD) Downstream 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 downstream processes, with a focus on antibodies and proteins, across early and late development stages. This role involves establishing robust, scalable purification strategies and CDMO oversight. Additionally, the role will support, tech transfer, 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 downstream process development for biologic programs from preclinical through late-stage development, ensuring scalability, robustness, and product quality.
• Lead tech transfer to CDMO manufacturing sites, ensuring successful execution at pilot and large scale.
• Design and direct process characterization studies, define control strategies, support PPQ, and technology transfer.
• Support downstream related investigation, CAPAs and process improvement initiatives.
• Provide technical oversight for viral clearance studies and ensure alignment with regulatory expectation.
• Contribute to defining process control strategies and lifecycle management plans in alignment with relevant guidelines.
• Author and review key technical and development reports, risk assessments, and regulatory submission documents (IND, IMPD, BLA).
• Partner with relevant stakeholders 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).
• Foster technical excellence and innovation within the drug substance 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 expertise in downstream development and manufacturing of monoclonal antibodies, including both early (Phase 1/2) and late-stage (Phase 3/commercial) programs.
• In-depth experience with chromatography, filtration, and viral clearance operations.
• Strong understanding of process scale-up, tech transfer and validation activities
• Hands-on 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%.