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Flagship Pioneering · 1 day ago

Senior Director, CMC Development, Biologics

Cambridge, MA USA

Full-time

Onsite

Director/Executive

$213K/yr - $280K/yr

15+ years exp

Metaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. The Senior Director, CMC Development & External Manufacturing will lead end-to-end CMC strategy and execution for biologics programs, ensuring that CMC deliverables support regulatory submissions and clinical supply needs.

FinanceFinancial ServicesVenture Capital

H1B Sponsor Likely

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

Qualification

Biologics CMC experienceGMP manufacturingExternal manufacturing oversightCMC strategy developmentCGMP/GxP knowledgeTechnical leadershipStakeholder influenceTeam buildingChange management

Required

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/GxP and quality systems, with clear, concise communication and stakeholder influence skills

Preferred

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

Benefits

Healthcare coverage

Annual incentive program

Retirement benefits

Broad range of other benefits

Company

Flagship Pioneering

Glassdoor3.3

Flagship Pioneering is a venture capital firm that invests in life sciences and healthcare companies.

Founded in 2000

Cambridge, Massachusetts, USA

501-1000 employees

http://flagshippioneering.com

H1B Sponsorship

Flagship Pioneering has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (8)

2024 (4)

2023 (4)

2022 (4)

2021 (1)