Senior Director, Biologics

Summary

Join Formation Bio, a tech and AI-driven pharma company, as a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities for biologic product development. This strategic leadership role involves advancing large molecule programs from early development through commercialization, overseeing internal and external teams, ensuring regulatory compliance, and scaling biologics capabilities. You will partner with technical, quality, and regulatory leaders, collaborate with data science and AI teams, and manage CMC timelines, budgets, and resources. The position requires expertise in biologics manufacturing processes, formulation development, analytical methods, and global regulatory requirements. You will author and review regulatory submissions and ensure compliance with global regulatory expectations.

Requirements

• 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
• 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 ability to lead cross-functional teams and manage complex, high-impact projects from early development through commercialization
• Experience authoring and reviewing INDs, BLAs, and other regulatory documents; comfort engaging with regulatory authorities
• Familiarity with Quality by Design (QbD) principles and their application in CMC development
• Demonstrated success working with third-party partners and CDMOs, including defining scope and driving accountability
• Strong verbal and written communication skills; able to clearly convey complex technical concepts to diverse audiences
• Comfortable in a fast-paced, evolving environment; thrives on collaboration, ownership, and moving with urgency

Responsibilities

• Develop and execute comprehensive CMC strategies for pre-clinical, clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards
• Build and lead a high-performing CMC team; foster a culture of ownership, innovation, and accountability
• 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
• 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
• Own CMC timelines, budgets, and resources across biologics programs; ensure delivery of high-quality milestones on schedule
• Provide scientific and technical leadership across process development, formulation, analytical methods, and technology transfer to manufacturing sites
• 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
• Stay current with emerging technologies, regulatory changes, and industry best practices; drive continuous improvement across all CMC operations

Benefits

• Equity
• Comprehensive benefits
• Generous perks
• Hybrid flexibility