Associate Director, Drug Product Development

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. 

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others. 

You can read more at the following links:

• Our Vision for AI in Pharma
• Our Current Drug Portfolio
• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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.

Responsibilities

Development and Manufacturing Strategy, Operations and Oversight

• 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

Additional Core CMC Responsibilities (Quality, Regulatory & Cross-Functional)

• 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, CT