Director, Early Stage CMC Program Lead

Generate Biomedicines•Somerville, MA

22h•$177,000 - $266,000•Remote

About The Position

We are seeking to expand our Technical Operations group by recruiting a highly experienced and collaborative 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.

Requirements

Ph.D. in Chemistry, Biochemistry, Chemical/Biological Engineering, Pharmaceutical Science or a related discipline with ~8+ years of relevant CMC or technical development experience; or MSc. with ~12+ years; or B.S. with ~14+ years of experience.
Proven experience in CMC development for biologics.
Experience working with external CROs/CDMOs for drug substance and drug product development and manufacturing is required.
Proficient project management and organizational skills, with the ability to manage multiple programs simultaneously and meet tight timelines.
Strong analytical and problem-solving skills, with a talent for anticipating challenges and balancing short-term needs with long-term program goals.
Demonstrated ability to lead cross-functional teams in a matrix environment.
Excellent communication and interpersonal skills, including the ability to clearly convey complex technical concepts to diverse audiences.
Skilled in authoring, reviewing, and approving technical documents (development reports, protocols, batch records, etc.) and ensuring compliance with cGMP and quality standards.
Broad knowledge of CMC regulatory requirements and industry best practices for biologics development.
A self-motivated, initiative-taking leader who thrives in a collaborative, fast-paced startup environment.
Ability to travel occasionally (e.g. to visit CDMOs or attend key meetings), as needed.

Nice To Haves

Direct familiarity with multiple biologic modalities – such as monoclonal and bispecific antibodies, T-cell engagers (TCEs), and antibody-drug conjugates (ADCs) – is highly desirable.
Strong technical experience in either biologics drug substance process development or analytical development is preferred, enabling effective CMC leadership and oversight of development, strategy, and CDMO execution.
Experience authoring or contributing to CMC sections of regulatory filings (IND/IMPD and beyond) for biologics is highly beneficial.
Familiarity with preparing responses to Health Authority questions and understanding of ICH/FDA/EMA guidelines for CMC is a plus.
Track record of successfully managing vendor relationships, tech transfers, and project deliverables with external partners.
Demonstrated ability to prioritize effectively in a dynamic environment.
Comfort with ambiguity and agility in adapting plans as programs evolve.
Skilled at influencing and aligning stakeholders across different functions without direct authority.
A proven track record of leading through influence and fostering a culture of collaboration, quality, and excellence.
A meticulous approach to data integrity and documentation.
Experience navigating complex technical or quality issues in manufacturing and development.
Eagerness to learn, adaptability, and a relentless drive to solve problems in service of bringing new medicines to patients.

Responsibilities

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.
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.
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.
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.
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.
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.
Maintain comprehensive documentation for each program, including CMC development plans, meeting minutes, technical reports, decision logs, and risk registers. Ensure that knowledge and data are well documented to support regulatory filings and future development stages.
Work closely with internal partners in Research, Process Development, Analytical Development, Formulation/Drug Product, Quality Assurance, Clinical, and Regulatory to align CMC activities with overall program objectives. Champion effective communication and knowledge-sharing across both internal teams and external partners to drive program success.
Take initiative and demonstrate ownership in driving programs forward. Motivate and influence cross-functional teams without direct reporting lines, fostering a culture of teamwork, quality, and continuous improvement. Bring a hands-on approach and creative problem-solving mindset to overcome challenges, and maintain flexibility to multi-task in a fast-paced environment.