139 cmc jobs at 65 companies in Manchester, NH
1mo
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Director, CMC Lead
Bedford or Waltham
$225k-$250k/yr HybridFull Time
10+ YOE5+ Mgmt10+ years CMC experience with drug-device combination products, 5+ years CMC leadership, bachelor's required (advanced degree preferred), deep CMC/regulatory knowledge, strong communication and cross-functional leadership.
1mo
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Director, Regulatory CMC
Boston, Massachusetts, United States
$182k-$275k/yr HybridFull Time
10+ YOEBS in life sciences, 10+ years regulatory CMC or related pharma experience, experience with peptides and injectable dosage forms, ability to author CMC submissions and coordinate cross-functional inputs.
2mo
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Director, Regulatory CMC
Somerville, Massachusetts, United States
$220k-$235k/yr HybridFull Time
10+ YOE10+ years biopharma CMC regulatory experience for biologics/gene therapies; bachelor’s or master’s in life sciences; experience with post-approval CMC submissions, GMP and global regulatory frameworks; strong communication and cross-functional skills.
3mo
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GRA CMC Specialist
Bern or King of Prussia or Waltham
OnsiteFull Time
5+ YOERegulatory CMC leadership role requiring 5+ years in regulatory affairs for biologics/plasma, with cross-functional collaboration and international submissions.
Regulatory submissions, Regulatory intelligence, Change control, Due diligence, SOPs
5d
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VP, CMC
Waltham, Massachusetts, United States
$300k-$340k/yr OnsiteFull Time
15+ YOE5+ MgmtPh.D. in relevant sciences or equivalent MS/BS experience; 15+ years in biologics development and manufacturing, including 5+ years as a CMC head; successful IND, IMPD, BLA, or MAA submissions and approvals.
SOPs, IND, IMPD, BLA, MAA, CAPAs, cGMP
2w
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Associate Director, CMC Lead
Boston, Massachusetts, United States
$137k-$205k/yr HybridFull Time
7+ YOE7+ years pharmaceutical/biopharma CMC experience, bachelor\u0002s required (advanced degree preferred), IND/IMPD and IND-enabling experience, process and analytical development, cross-functional leadership and regulatory authorship experience.
2w
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Associate Director, CMC Lead
Boston, Massachusetts, United States
$137k-$205k/yr HybridFull Time
7+ YOE7+ years pharmaceutical/biopharma CMC development and manufacturing experience; Bachelor\u0002s required (advanced degree preferred); IND-enabling and process/analytical development experience; cross-functional leadership and strategic decision-making.
4w
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Director/ Senior Director, Regulatory CMC
Boston, Massachusetts, United States
$200k-$265k/yr OnsiteFull Time
8+ YOEDoctorate preferred; ≥8 years Regulatory CMC biologics experience with FDA sCDER interactions, global submissions, lifecycle management, and biologics/combination product development.
3mo
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Director/Senior Director, CMC, Drug Substance
Boston or Needham
$222k-$303k/yr HybridFull Time
10+ YOEPhD in Chemistry or Chemical Engineering with 10+ years API CDMO experience; regulatory CMC writing; CDMO selection and tech transfer; extensive cGMP knowledge.
CDMO management, CMC, Regulatory writing, GxP
2mo
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Associate Director, Regulatory Affairs CMC
Boston, Massachusetts, United States
$165k-$180k/yr HybridFull Time
12+ YOEBachelor's in relevant science required; 12+ years regulatory CMC experience (10+ with advanced degree); direct CMC experience for biologics/cell & gene therapies; knowledge of FDA/EMA/ICH and eCTD submissions.
eCTD
1mo
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Associate Director, Regulatory CMC (Biologics)
Waltham, Massachusetts, United States
$182k-$208k/yr HybridFull Time
6+ YOEMaster's or PhD in life sciences, 6+ years CMC experience with minimum 3+ years regulatory CMC in biologics, cGMP and global regulatory submission expertise (FDA/EMA/ICH), experience authoring Module 3 and combination product submissions.
1w
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Senior Director, Regulatory CMC
Boston, Massachusetts, United States
$265k-$285k/yr HybridFull Time
12+ YOEBachelor’s degree in a scientific discipline and 12+ years of Regulatory CMC experience in biotech or pharma, including global registration, submissions, health authority interactions, and cross-functional leadership.
FDA, EMA, ICH, INDs, IMPDs, NDA, MAA, CTD Module 3
2mo
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Director, Regulatory Affairs CMC
Waltham, Massachusetts, United States
$207k-$253k/yr OnsiteFull Time
12+ YOEBS in life sciences or equivalent experience (advanced degree preferred); minimum 12 years relevant experience with 8-10 years regulatory CMC experience; strategic CMC regulatory expertise; experience with global health authorities; strong communication and negotiation skills.
6d
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GRA CMC Specialist
Broadmeadows or King of Prussia or Melbourne or Waltham
OnsiteFull Time
5+ YOEBachelor's degree in biological or chemical sciences or related field; 5+ years of progressive regulatory experience in biologics or plasma; expertise in global regulations, CMC submissions, compliance, and cross-functional leadership.
2w
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Associate Director, CMC Lead
Boston, Massachusetts, United States
$137k-$205k/yr HybridFull Time
7+ YOE7+ years pharmaceutical product development and manufacturing experience; Bachelor's degree required (advanced degree preferred); IND-enabling CMC, process and analytical development, project leadership, cross-functional collaboration.
1mo
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CMC Asset Lead, Nephrology
Cambridge or Research Triangle Park or San Francisco
$204k-$281k/yr HybridFull Time
12+ YOE12+ years' experience in matrix leadership with CMC/supply chain or life cycle management; BS required, advanced degree preferred; alliance and financial management experience; strong strategic, communication and risk-management skills.
3w
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Director, ADC CMC Sciences
Waltham, Massachusetts, United States
$161k-$305k/yr HybridFull Time
12+ YOEExtensive CMC leadership for small molecule development through IND/NDA/MAA; technical, regulatory and project leadership with strong communication and strategic skills.
2mo
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Executive Director, Regulatory Affairs CMC
Waltham, Massachusetts, United States
$290k-$323k/yr OnsiteFull Time
12+ YOE12+ years regulatory affairs CMC experience in pharma/biotech, advanced scientific degree required, strong regulatory negotiation and submission experience (INDs/BLAs/MAAs), leadership and communication skills.
1mo
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Director/Senior Director, CMC Operations
Cambridge, Massachusetts, United States
$210k-$320k/yr OnsiteFull Time
10+ YOEAdvanced degree in life sciences or engineering,10+ years CMC development experience with leadership, expertise in nucleic acid/LNP manufacturing and analytics, regulatory submission experience, strong risk management and communication skills.
HPLC, NGS, PCR, ELISA, MS, RNA quantitation
2mo
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Associate Director, Regulatory Affairs, CMC
United States or Philadelphia or Cambridge
$171k-$231k/yr HybridFull Time
8+ YOEAdvanced degree in a relevant scientific discipline, 8+ years industry experience including 5+ years in Regulatory Affairs CMC, experience with regulatory submissions and health authority interactions, strong communication and cross-functional leadership.
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