Associate Director, Drug Product Development

Formation Bio•Boston, MA

19h•Hybrid

About The Position

The Associate Director, Drug Product, will provide strategic and hands-on operational leadership for all CMC activities related to drug product development and manufacturing, with a primary focus on sterile injectables (lyophilized and liquid) at all stages of development (IND-enabling to commercialization). The Associate Director, Drug Product, will be responsible for overseeing the formulation development, fill-finish, packaging, and release of drug products at CDMOs ensuring manufacturing operations align with program timelines, quality standards, and regulatory requirements. This position requires deep expertise in biologics drug product manufacturing, 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 product manufacturing, formulation development, and fill-finish operations.
Demonstrated track record of successfully managing drug product 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 aseptic fill-finish operations, lyophilization processes, formulation development, stability programs, and drug product characterization for biologics.
Extensive experience working with CDMOs and contract manufacturing organizations, including site selection, technology transfers, manufacturing oversight, and performance management. Proven ability to troubleshoot complex manufacturing issues and drive continuous improvement initiatives.
Strong knowledge of cGMP regulations, FDA and EMA guidelines, ICH quality guidelines, and regulatory expectations for drug product manufacturing.
Experience authoring and reviewing CMC sections of regulatory submissions (INDs, BLAs, CTAs) related to drug product manufacturing and validation activities.
Strong project management skills with demonstrated ability to manage multiple manufacturing programs simultaneously, meet aggressive timelines, and navigate competing priorities.
Excellent communication and interpersonal skills with ability to influence and build strong relationships with internal stakeholders and external manufacturing partners.
Willingness to travel domestically and internationally (approximately 20-30%) to manufacturing sites for audits, manufacturing oversight, and technical meetings.

Responsibilities

Lead drug product 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 and contract manufacturing organizations for drug product manufacturing activities. Establish and maintain strong partnerships, lead technical discussions, and ensure manufacturing excellence across external manufacturing networks.
Oversee formulation, aseptic fill-finish, lyophilization (if applicable), visual inspection, labeling, and packaging operations for drug products. 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 product for clinical trials and commercial supply.
Lead technical assessments and qualification of new CDMOs for drug product 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 Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Clinical Supply, and Project Management leads to ensure seamless integration of manufacturing activities into overall program execution.
Collaborate with procurement to ensure timely contracting for drug product manufacturing.