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.

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.

Heres 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 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.
• Collaboration: 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.
• Leadership & Initiative: 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.

The Ideal Candidate will have:

• Education & Experience: 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.
• Biologics CMC Expertise: Proven experience in CMC development for biologics. Direct familiarity with multiple biologic modalities such as monoclonal and bispecific antibodies T-cell engagers (TCEs) and antibody-drug conjugates (ADCs) is highly desirable.
• Drug Substance or Analytical Development Expertise (Biologics/mAbs): 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.
• CDMO Management: Experience working with external CROs/CDMOs for drug substance and drug product development and manufacturing is required. Track record of successfully managing vendor relationships tech transfers and project deliverables with external partners.
• Regulatory Filing Experience: 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.
• Project Management Skills: Proficient project management and organizational skills with the ability to manage multiple programs simultaneously and meet tight timelines. Demonstrated ability to prioritize effectively in a dynamic environment.
• Problem Solving & Adaptability: Strong analytical and problem-solving skills with a talent for anticipating challenges and balancing short-term needs with long-term program goals. Comfort with ambiguity and agility in adapting plans as programs evolve.
• Cross-Functional Leadership: Demonstrated ability to lead cross-functional teams in a matrix environment. Skilled at influencing and aligning stakeholders across different functions without direct authority.
• Communication & Influence: Excellent communication and interpersonal skills including the ability to clearly convey complex technical concepts to diverse audiences. A proven track record of leading through influence and fostering a culture of collaboration quality and excellence.
• Documentation & Quality Mindset: Skilled in authoring reviewing and approving technical documents (development reports protocols batch records etc.) and ensuring compliance with cGMP and quality standards. A meticulous approach to data integrity and documentation.
• Industry Knowledge: Broad knowledge of CMC regulatory requirements and industry best practices for biologics development. Experience navigating complex technical or quality issues in manufacturing and development.
• Motivation & Culture Fit: A self-motivated initiative-taking leader who thrives in a collaborative fast-paced startup environment. Eagerness to learn adaptability and a relentless drive to solve problems in service of bringing new medicines to patients.
• Flexibility: Ability to travel occasionally (e.g. to visit CDMOs or attend key meetings) as needed.

Who Will Love This Job:

Join us and play a pivotal role in advancing Generates cutting-edge portfolio of AI-generated biotherapeutics. If you are excited by innovative science cross-functional leadership and making a real impact 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 Companys 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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