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 millionin 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.

What You’ll Need (Qualifications):

• Ph.D. in Chemistry, Biochemistry, Chemical/Biological Engineering, Pharmaceutical Sciences, or related field with 12+ years of CMC/technical development experience; or M.S. with ~15+ years; or B.S. with ~18+ years.
• Proven strategic leadership in CMC development for biologics, with familiarity across multiple modalities (mAbs, bispecifics, TCEs, ADCs, etc.).
• Demonstrated success leading complex programs at the enterprise or portfolio level, influencing executive decisions, and shaping regulatory strategy.
• Track record of executive-level CDMO management, including negotiating contracts, overseeing tech transfers, and ensuring quality delivery.
• Experience authoring and directing CMC regulatory submissions (IND/IMPD and beyond) and engaging directly with regulatory authorities.
• Strong business and program management skills, with accountability for budgets, timelines, and cross-functional outcomes.
• Exceptional communication and influence skills—able to inspire, align, and motivate across internal teams, executive leadership, external partners, and regulators.
• Recognized internally and externally as a thought leader, with contributions to advancing CMC development practices.

Nice to Have (Optional):

• Experience with AI/ML-enabled biologics development.
• External publications, presentations, or industry recognition in CMC or biopharmaceutical development.
• Prior leadership in a biotech startup environment, balancing strategic vision with hands-on execution.

Why Join Us:At Generate, you will play a pivotal leadership role in advancing a cutting-edge portfolio of AI-generated biotherapeutics. You will shape not only program outcomes but also the future of CMC development in a rapidly scaling biotech environment. If you are excited by scientific innovation, strategic influence, and the opportunity to drive transformative impact for patients, we encourage you to apply.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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