Flagship Pioneering
Senior Director, CMC Development, Biologics
Flagship Pioneering, Cambridge, Massachusetts, us, 02140
Company Description
Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new mimic‑discovery platform. Role Summary
Metaphore is seeking a Senior Director, CMC Development & External Manufacturing to lead end‑to‑end CMC strategy and execution for our biologics programs. This individual will have primary accountability for developing fit‑for‑stage drug substance and drug product processes with external manufacturing CDMOs. This leader will own the integrated CMC plan (strategy, timeline, budget, and risks), partner with key internal stakeholders to enable seamless transition into late‑stage CMC work and ensure CMC deliverables support regulatory submissions and clinical supply needs. Key Responsibilities
Own end‑to‑end CMC strategy and execution, including governance, integrated plans (timeline/resources/interdependencies), scenario planning, supply forecasting, and risk management to deliver program and company milestones. Lead external CDMO strategy and oversight for drug substance and drug product (scope setting, operating cadence, deliverables/action tracking, issue escalation/resolution), ensuring execution success. Provide technical leadership across upstream/downstream, analytical, formulation, fill/finish, and stability, guiding fit‑for‑stage development decisions (e.g., scale‑up strategy, formulation/container strategy, stability approach) and tech transfer readiness. Ensure phase‑appropriate GMP readiness and campaign execution at the CDMO, including deviation/change/CAPA alignment with Quality and ensuring testing and disposition timelines support clinical needs. Drive CMC regulatory deliverables (CMC sections of submissions/amendments) and executive‑level communication of status, decisions, risks, and mitigation plans; build/lead high‑performing internal and matrixed teams. Required Qualifications
Advanced degree (PhD preferred; MS with significant experience considered) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline. 15+ years of biologics CMC experience spanning development through GMP manufacturing and external manufacturing oversight (drug substance and/or drug product). Proven ability to define CMC strategy and translate it into cross‑functional deliverables, integrated plans, timelines, and budgets, with strong program leadership and operating rigor. Demonstrated success managing external collaborations/CDMOs to deliver CMC development and manufacturing outcomes in fast‑paced, matrixed environments. Strong technical breadth in at least one major CMC area (and ability to lead across all), including upstream/downstream, analytics, and/or fill/finish/drug product with stability/tech transfer exposure. Deep working knowledge of cGMP/GxPand quality systems, with clear, concise communication and stakeholder influence skills. Desired Skills
Define and execute strategic vision to advance scientific innovation, translating emerging insights into high‑impact initiatives, roadmaps, and measurable outcomes. Act decisively and own end‑to‑end accountability, making timely, data‑informed decisions, taking responsibility for results, and delivering against commitments in dynamic environments. Build change‑agile, high‑performing teams and networks, growing others through coaching and development, modeling strong self‑awareness, and cultivating relationships with external thought leaders to accelerate learning and partnerships. Equal Opportunity Employer
We are an equal opportunity employer . All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. We recognize that great candidates often bring unique strengths
without fulfilling every qualification . If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background
and interest in Flagship. The salary range for this role is $213,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Metaphore Biotechnologies, Inc.'s good faith estimate as of the date of publication and may be modified in the future.
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Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new mimic‑discovery platform. Role Summary
Metaphore is seeking a Senior Director, CMC Development & External Manufacturing to lead end‑to‑end CMC strategy and execution for our biologics programs. This individual will have primary accountability for developing fit‑for‑stage drug substance and drug product processes with external manufacturing CDMOs. This leader will own the integrated CMC plan (strategy, timeline, budget, and risks), partner with key internal stakeholders to enable seamless transition into late‑stage CMC work and ensure CMC deliverables support regulatory submissions and clinical supply needs. Key Responsibilities
Own end‑to‑end CMC strategy and execution, including governance, integrated plans (timeline/resources/interdependencies), scenario planning, supply forecasting, and risk management to deliver program and company milestones. Lead external CDMO strategy and oversight for drug substance and drug product (scope setting, operating cadence, deliverables/action tracking, issue escalation/resolution), ensuring execution success. Provide technical leadership across upstream/downstream, analytical, formulation, fill/finish, and stability, guiding fit‑for‑stage development decisions (e.g., scale‑up strategy, formulation/container strategy, stability approach) and tech transfer readiness. Ensure phase‑appropriate GMP readiness and campaign execution at the CDMO, including deviation/change/CAPA alignment with Quality and ensuring testing and disposition timelines support clinical needs. Drive CMC regulatory deliverables (CMC sections of submissions/amendments) and executive‑level communication of status, decisions, risks, and mitigation plans; build/lead high‑performing internal and matrixed teams. Required Qualifications
Advanced degree (PhD preferred; MS with significant experience considered) in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or related discipline. 15+ years of biologics CMC experience spanning development through GMP manufacturing and external manufacturing oversight (drug substance and/or drug product). Proven ability to define CMC strategy and translate it into cross‑functional deliverables, integrated plans, timelines, and budgets, with strong program leadership and operating rigor. Demonstrated success managing external collaborations/CDMOs to deliver CMC development and manufacturing outcomes in fast‑paced, matrixed environments. Strong technical breadth in at least one major CMC area (and ability to lead across all), including upstream/downstream, analytics, and/or fill/finish/drug product with stability/tech transfer exposure. Deep working knowledge of cGMP/GxPand quality systems, with clear, concise communication and stakeholder influence skills. Desired Skills
Define and execute strategic vision to advance scientific innovation, translating emerging insights into high‑impact initiatives, roadmaps, and measurable outcomes. Act decisively and own end‑to‑end accountability, making timely, data‑informed decisions, taking responsibility for results, and delivering against commitments in dynamic environments. Build change‑agile, high‑performing teams and networks, growing others through coaching and development, modeling strong self‑awareness, and cultivating relationships with external thought leaders to accelerate learning and partnerships. Equal Opportunity Employer
We are an equal opportunity employer . All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. We recognize that great candidates often bring unique strengths
without fulfilling every qualification . If you have some of the experience listed above but not all, please apply anyway. We are dedicated to building diverse and inclusive teams and look forward to learning more about your background
and interest in Flagship. The salary range for this role is $213,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Metaphore Biotechnologies, Inc.'s good faith estimate as of the date of publication and may be modified in the future.
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