Director, Early Stage CMC Program Lead

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role: 

We are seeking to expand our Technical Operations group by recruiting a highly experienced and collaborative Associate Director to serve as an Early Stage CMC Program Lead. This role is responsible for end-to-end Chemistry, Manufacturing, and Controls (CMC) program oversight for early-stage biologic programs (from preclinical development through early clinical trials) managed at external CDMOs – with no internal manufacturing infrastructure. Reporting to the Vice President of Technical Operations and working closely with cross-functional CMC teams, the successful candidate will be accountable for overall CMC program strategy and execution for one or more programs. You will coordinate subject matter experts in Drug Substance Process Development, Drug Product, and Analytical Development (who are part of the program team but do not report directly) to ensure program goals are met.

This position includes developing and executing integrated CMC development plans for novel biotherapeutic candidates, ensuring cross-functional alignment with program objectives and regulatory expectations. The Program Lead will manage external development and manufacturing activities, and proactively identify CMC risks with mitigation strategies throughout the development of the assigned programs.

This role also provides a unique opportunity to drive the development of AI-designed, next-generation biotherapeutics while enjoying a high degree of independence in daily work. It offers abundant opportunities for cross-functional collaboration and learning, contributions to program direction and scope, and involvement in shaping CMC sections of regulatory documents – all in a well-funded and dynamic biotech startup environment.

Here's how you will contribute:

• End-to-End CMC Oversight: Lead the CMC aspects of early-stage programs to ensure all development, manufacturing, and testing activities are coordinated and meet required quality standards, timelines, and regulatory requirements.
• Cross-Functional Leadership: Guide a matrixed CMC team (including Drug Substance process development, Drug Product, and Analytical leads) to plan and execute an integrated CMC strategy for each program. Align cross-functional efforts and foster collaboration among team members without direct authority.
• External CDMO Management: Serve as the primary point of contact for external Contract Development and Manufacturing Organizations (CDMOs) and testing partners. Manage these relationships (including tech transfer, contracting, and performance oversight) to ensure successful development, manufacturing, and testing of drug substance and drug product at external sites.
• Timeline & Milestone Management: Develop and maintain detailed CMC project plans aligned with overall program timelines. Track progress and drive the on-time execution of process development, scale-up, clinical manufacturing, and analytical testing deliverables. Adjust plans proactively to accommodate changes in scope or priorities.
• Risk Mitigation: Identify potential CMC risks (technical, regulatory, supply chain) early in the program and devise mitigation strategies. Facilitate risk assessment discussions and lead the resolution of CMC issues to keep programs on track.
• Regulatory Support: Oversee and contribute to the preparation of CMC content for regulatory submissions (e.g. authoring and reviewing CMC sections of IND/IMPD filings). Collaborate with Regulatory Affairs to craft responses to Health Authority inquiries, ensuring CMC documentation and strategy comply with global regulatory guidelines.
• Program Documentation: Maintain comprehen