- Developing CMC strategy from drug substance to clinical packaging readiness.
- Providing hands-on leadership across analytical method development/validation; formulation development; stability programs; phase-appropriate control strategies.
- Selecting and managing external partners (CDMOs); reviewing SOWs/budgets/timelines/quality/performance.
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About the job · Summary: · The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development act ...
Boston3 days ago
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About the job · Summary: · The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development act ...
Greater Boston2 days ago
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Lead the transition of next-generation biologics from Discovery into the clinic. · PhD in a relevant scientific field with 10+ years of industry experience. · Deep expertise in the development of complex antibodies, ADCs, or multispecifics. · ...
Cambridge, MA2 months ago
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Director, Regulatory Affairs - CMC (Individual Contributor) · Location: Flexible (U.S. based only, remote or hybrid options available) · Employment Type: Full-time · Summary: · A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regu ...
Boston $220,000 - $320,000 (USD) per year1 week ago
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Director, Regulatory Affairs - CMC (Individual Contributor) · Location: Flexible (U.S. based only, remote or hybrid options available) · Employment Type: Full-time · Summary: · A growing biopharmaceutical company is seeking a Director, Regulatory Affairs - CMC to lead global regu ...
Boston, MA $220,000 - $320,000 (USD) per year1 week ago
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SciPro partnered with a late-stage biotech seeking a Director, Regulatory CMC to join their team full-time. · This role leads global regulatory strategies and guides submissions ensuring compliance throughout product lifecycle. · ...
Boston2 weeks ago
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SciPro is partnered with an exciting late-stage biotech that is seeking a Director, Regulatory CMC to join their team full-time. · ...
Greater Boston2 weeks ago
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The CMC team within Alira Health Boston LLC advises and assists biotechnology companies to manufacture therapeutic biologics for clinical testing. · This is a leadership role to help guide and manage the CMC group, · working in partnership with the Senior Vice President.Serve on ...
Boston1 month ago
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Amylyx is looking for a highly experienced Senior Director to lead the CMC organization to develop Amylyx's pipeline including Phase III synthetic peptide and Phase I antisense oligonucleotide. · ...
Cambridge $246,000 - $277,000 (USD) Full time1 month ago
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· Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage co ...
Cambridge, MA $230,000 - $360,000 (USD) per year20 hours ago
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Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. We are seeking a highly experienced Senior Director, Chemistry, Manufacturing and Controls (CMC), to lead the CMC organization. · ...
Cambridge, MA1 month ago
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Join our global team dedicated to innovation and initiative... · ...
Greater Boston1 month ago
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Amylyx está buscando a un Senior Director, Chemistry, Manufacturing, and Controls (CMC), para liderar el equipo CMC en el desarrollo del pipeline de productos incluyendo Avexitide y AMX0114. · Partner con equipos para ejecutar estrategias CMC desde la fase temprana hasta la comer ...
Cambridge, MA1 month ago
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About WuXi XDC we are looking for a CMC lead to manage our projects from proposal stage through project completion. This position will offer flexibility working remotely in US or EU locations. · The incumbent will lead the orderly progression of projects. · ...
Boston1 month ago
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About WuXi XDC is a leading Contract Research Development and Manufacturing Organization focused on the global antibody drug conjugates ADCs and broader bioconjugate market. · The incumbent will lead the orderly progression of projects from proposal stage through project completi ...
Boston, MA1 month ago
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The Executive Director will provide strategic leadership for global CMC regulatory activities across all stages of drug development and life cycle management. Reporting to the SVP Regulatory and Medical Writing this role serves as a liaison to health authorities driving regulator ...
Boston $285,000 - $370,000 (USD)1 month ago
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We are growing our Regulatory Affairs organization and are seeking a proactive and detail‑oriented professional to support global Regulatory CMC activities across our clinical programs.This is an exciting opportunity to contribute to high‑impact development efforts within a fast‑ ...
Boston1 month ago
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At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailer ...
Boston $192,000 - $235,000 (USD)2 weeks ago
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We are looking for an Associate Director, Regulatory CMC to work closely with cross-functional subject matter experts to provide strategic and operational input for CMC regulatory activities including submissions, reviews, and health authority interactions. · ...
Boston, MA1 month ago
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· Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts. Centessa is advancing a portfolio of high conviction programs with strong biological ...
Boston, MA $285,000 - $370,000 (USD) per year6 days ago
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We are seeking a Director, Regulatory Affairs to join our team. This position reports to the Executive Director and will be based out of Boston in our Needham office. Responsibilities include proposing and implementing global CMC regulatory strategies and providing guidance to cr ...
Boston $224,600 - $248,400 (USD)3 weeks ago
Senior Director, CMC - Boston, MA - Genepool Networks
Description
Senior Director, CMC Role Summary
This role leads end-to-end Chemistry, Manufacturing, and Controls strategy for a growing small-molecule pipeline from development candidate selection through INDs and Phase 1 clinical supply. The Senior Director will work in a highly cross-functional and externally partnered environment.
Main Responsibilities:
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CMC Director
Only for registered members Boston
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CMC Director
Only for registered members Greater Boston
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Director of CMC
Only for registered members Cambridge, MA
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Director Regulatory CMC
Only for registered members Boston
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Director Regulatory CMC
Only for registered members Boston, MA
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Director, Regulatory CMC
Only for registered members Boston
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Director, Regulatory CMC
Only for registered members Greater Boston
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Director CMC Operations
Only for registered members Boston
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Senior Director, CMC
Full time Only for registered members Cambridge
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Senior Director, CMC
Only for registered members Cambridge, MA
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Senior Director, CMC
Only for registered members Cambridge, MA
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Director CMC Operations
Only for registered members Greater Boston
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Senior Director, CMC
Only for registered members Cambridge, MA
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Director/Senior Director,CMC lead
Only for registered members Boston
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Director/Senior Director,CMC lead
Only for registered members Boston, MA
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Executive Director, Regulatory CMC
Only for registered members Boston
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Associate Director, Regulatory CMC
Only for registered members Boston
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Director, CMC Regulatory Affairs
Only for registered members Boston
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Associate Director, Regulatory CMC
Only for registered members Boston, MA
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Executive Director, Regulatory CMC
Only for registered members Boston, MA
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Director, Regulatory Affairs, CMC
Only for registered members Boston