Associate Director, Drug Substance, Biologics

Formation Bio•Boston, MA

3h•$185,000 - $235,000•Hybrid

About The Position

The Associate Director, Drug Substance, Biologics, will provide technical, strategic and hands-on operational leadership for all CMC activities related to drug substance development and manufacturing, with a primary focus on Biologics at all stages of development (IND-enabling to commercialization). The Associate Director, Drug Substance, will be responsible for overseeing the process development, manufacturing and release of drug substances at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug substance manufacturing (either cell culture or downstream purification), strong technical problem-solving abilities, and proven experience managing complex manufacturing operations with external partners. You will play a critical role in accelerating our mission of bringing new treatments to patients faster and more efficiently.

Requirements

MS or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, or related discipline.
6+ years of experience in the biopharmaceutical industry with hands-on experience in biologics drug substance manufacturing (either cell culture or downstream purification)
Demonstrated track record of successfully managing drug substance manufacturing campaigns for biologics (proteins, monoclonal antibodies, antibody-drug conjugates, or other large molecules) from preclinical through late-stage clinical or commercial manufacturing.
Technical expertise in either cell culture or downstream purification for process development, manufacturing, process characterization and process validation for biologics.
Extensive experience working with CDMOs, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.

Responsibilities

Lead drug substance manufacturing strategy and execution for programs from preclinical through commercial stages, ensuring alignment with program objectives, timelines, and budget constraints.
Serve as the primary technical interface with CDMOs for drug substance manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing network.
Oversee cell culture and downstream purification activities related to process development and manufacturing for both microbial and mammalian expression systems. Ensure manufacturing processes are robust, scalable, and compliant with cGMP requirements.
Provide technical guidance and oversight for manufacturing campaigns including batch record review and approval, deviation investigations, change control assessments, and resolution of manufacturing issues
Support scale-up activities from clinical to commercial manufacturing, including process optimization and validation. Identify and implement continuous improvement opportunities.
Develop comprehensive manufacturing plans and schedules in collaboration with Project Management, Clinical Supply, and Commercial teams. Track manufacturing timelines and proactively manage risks to ensure on-time delivery of drug substance for clinical trials and commercial supply.
Lead technical assessments and qualification of new CDMOs for drug substance manufacturing. Conduct site audits and ongoing performance monitoring. Manage relationships with multiple manufacturing partners across different geographic regions
Ensure all manufacturing activities comply with cGMP regulations, ICH guidelines, and internal quality standards. Support regulatory inspections and audits at manufacturing sites. Review and approve batch records, protocols, and manufacturing-related documentation.
Author and review CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing, process validation, and manufacturing site changes. Support responses to health authority questions.
Partner closely with Drug Product Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Program Management leads to ensure seamless integration of manufacturing activities into overall program execution.
Collaborate with procurement to ensure timely contracting for drug substance manufacturing.