Senior Director, CMC Development, Biologics jobs in United States
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Metaphore Biotechnologies · 2 days ago

Senior Director, CMC Development, Biologics

positionCambridge, MA
timeFull-time
remoteOnsite
seniorityDirector/Executive
money$213K/yr - $280K/yr
date15+ years exp

Metaphore Biotechnologies, Inc. is a privately held biotechnology company focused on developing biological therapeutics. The Senior Director, CMC Development & External Manufacturing will lead the CMC strategy and execution for biologics programs, ensuring alignment with regulatory submissions and clinical supply needs.

BiotechnologyProduct ResearchTherapeutics
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H1B Sponsor Likelynote

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 experienceCMC strategy developmentExternal manufacturing oversightCGMP/GxP knowledgeCross-functional deliverablesTechnical leadershipStakeholder influenceTeam buildingCoachingDevelopment

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
A broad range of other benefits

Company

Metaphore Biotechnologies

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Metaphore Biotechnologies is a firm that uses biomimicry and machine learning to unlock the revolutionary therapeutic.
dateFounded in 2021
location
Cambridge, Massachusetts, USA
people-size11-50 employees
web-link
https://metaphorebio.com

H1B Sponsorship

Metaphore Biotechnologies 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (1)

Funding

Current Stage
Early Stage
Total Funding
$50M
Key Investors
Flagship Pioneering
2023-05-16Undisclosed· $50M

Leadership Team

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Lovisa Afzelius
Co-founder & CEO
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Daniel Acker
Cofounder & Chief Innovation Officer
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Recent News

citybiz
Metaphore Biotechnologies Appoints Anabella Villalobos as Chief Scientific Officer
2025-09-12
PR Newswire
Metaphore Biotechnologies Expands Executive Leadership Team with Appointment of Anabella Villalobos as Chief Scientific Officer
2025-09-10
Seattle TechFlash
Pfizer leader who launched Covid vaccine gives small pharma a try
2025-04-09
Company data provided by crunchbase