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.

Location / Work Type:
Somerville, MA or Andover, MA – Hybrid with periodic travel to CDMOs and regulatory meetings.

The Role: 

We are seeking a highly experienced and strategic Director, Early Stage CMC Program Lead to join our Technical Operations group. In this enterprise-level leadership role, you will set and drive the end-to-end Chemistry, Manufacturing, and Controls (CMC) strategy for early-stage biologic programs, ensuring seamless advancement from preclinical development through early clinical trials. You will serve as the accountable leader for CMC program direction, execution, and long-term planning, operating in close partnership with executive leadership, cross-functional CMC teams, and external CDMOs.

This is a pivotal role at the intersection of science, operations, and strategy—responsible not only for program delivery but also for shaping Generate’s CMC development frameworks, influencing regulatory strategy, and representing Generate externally with partners and regulatory authorities.

Key Responsibilities:

• Strategic CMC Leadership: Define and drive the integrated CMC development strategy for early-stage programs, ensuring alignment with Generate’s long-term portfolio goals and global regulatory expectations.
• Enterprise Influence: Serve as a trusted advisor to executive leadership, providing insight into CMC risks, opportunities, and strategic trade-offs. Shape organizational approaches to CMC development and influence decision-making across the company.
• Cross-Functional Leadership: Lead and inspire a matrixed team of Drug Substance, Drug Product, and Analytical subject matter experts. Ensure cross-functional alignment and foster collaboration to achieve ambitious program objectives.
• External CDMO & Partner Management: Act as primary executive-level liaison with external CDMOs, CROs, and testing partners. Oversee contractual and strategic relationships, ensuring successful technology transfer, scale-up, and manufacturing of clinical supplies.
• Regulatory Strategy & Engagement: Direct preparation of CMC sections for IND/IMPD submissions and responses to Health Authority questions. Represent Generate in regulatory interactions, ensuring compliance while influencing regulatory pathways for innovative modalities.
• Program & Risk Oversight: Own CMC program budgets, timelines, and milestones, ensuring delivery against company objectives. Anticipate and mitigate enterprise-level risks (technical, regulatory, supply chain) with proactive strategies.
• Organizational Contribution: Serve as a thought leader internally and externally. Represent Generate at scientific conferences, industry forums, and in interactions with regulators and partners to enhance the company’s visibility and reputation.

Leadership Responsibilities:
Aligned to Generate’s Leading Others and Leading Organization behaviors, you will:

• Build and empower high-performing, diverse teams by fostering inclusion, collaboration, and accountability.
• Drive enterprise-wide outcomes by ensuring CMC program strategies align with Generate’s long-term vision.
• Champion a culture of transparent, courageous communication—sharing learnings, addressing challenges head-on, and motivating teams through clarity and empathy.
• Role model adaptability and calculated risk-taking, encouraging innovation and resilience in pursuit of audacious goals.