Senior Director, Biologics

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

We are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic product development at Formation Bio. This is a strategic and execution-focused leadership role, responsible for advancing large molecule programs from early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance, and play a key role in scaling our biologics capabilities in partnership with technical, quality, and regulatory leaders.

Responsibilities

• Strategic Leadership
• Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards.

• Team Development
• Build and lead a high-performing CMC team; foster a culture of ownership, innovation, and accountability.

• Cross-Functional Collaboration & External Partnerships
• Partner closely with analytical development, manufacturing, quality, and regulatory teams to ensure seamless execution of CMC plans.
• Establish and manage key relationships with CDMOs and other external partners to support development and manufacturing activities.

• AI, Data Science, and Technology Integration
• Collaborate with technical, data science, and AI teams to identify and implement opportunities where machine learning, advanced analytics, and automation can enhance efficiency, reduce timelines, and support decision-making in biologics development and manufacturing.

• Project Management
• Own CMC timelines, budgets, and resources across biologics programs; ensure delivery of high-quality milestones on schedule.

• Technical Oversight
• Provide scientific and technical leadership across process development, formulation, analytical methods, and technology transfer to manufacturing sites.

• Regulatory Compliance & Submissions
• Ensure all CMC activities comply with global regulatory expectations (e.g., FDA, EMA, ICH); author and review regulatory submissions including INDs, BLAs, and other key documents.

• Continuous Improvement
• Stay current with emerging technologies, regulatory changes, and industry best practices; drive continuous improvement across all CMC operations.

About You

Relevant Experience

• 10+ years of experience in the biopharmaceutical industry, with deep expertise in CMC development for biologics.
• Prior experience in a leadership role within a CDMO or biopharmaceutical company.

Background and Skills

• MS or Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or a related field.
• In-depth knowledge of biologics manufacturing processes, formulation development, analytical methods, and global regulatory requirements.
• Proven