168 cmc jobs at 92 companies in California
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CMC Regulatory Lead
Redwood City, California, United States
$200k-$240k/yr OnsiteFull Time
7+ YOE7+ years hands-on regulatory CMC experience, experience leading CMC strategy for cell therapies, IND/CTA experience, ability to prepare CMC dossiers and lead health-authority interactions; life sciences degree preferred.
1w
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Head of CMC
Redwood City, California, United States
$278k-$416k/yr OnsiteFull Time
15+ YOE15+ years of biologics CMC or technical operations experience, bispecific antibody expertise, GMP campaign accountability, external CDMO leadership, CMC regulatory filing experience, and a relevant bachelor's or advanced degree.
CDMO, FDA, EMA, ICH, IND, IMPD, CTA, BLA, CHO, UF/DF, FSA
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Senior Director, CMC Management (5549)
California or Oregon or Washington
$161k-$274k/yr RemoteFull Time
8+ YOEAdvanced degree (PhD/MS) with 8+ years relevant biologics CMC experience, regulatory/ICH knowledge, multi‑functional CMC expertise, project and people management, English and basic Mandarin communication.
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Senior Scientist, Analytical CMC
Millbrae, California, United States
$154k-$186k/yr OnsiteFull Time
5+ YOEDegree in analytical chemistry or related field with ~5+ years relevant analytical/CMC experience; hands-on method development, transfer, validation; knowledge of HPLC/UPLC, GC, LC-MS, KF, spectroscopy, stability and regulatory CMC expectations.
HPLC, UPLC, dissolution, GC, LC-MS, KF, spectroscopy
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Director / Senior Director, Lirentelimab CMC Team Leader
Redwood City, California, United States
OnsiteFull Time
14+ YOEDirector/ Senior Director-level CMC leadership for lirentelimab; 14+ years in biotech with BLA/submission experience; cross-functional team leadership.
CMC, Regulatory, Quality, Bioanalytics, Process Development, Manufacturing
3w
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Associate Director, Regulatory CMC
San Carlos, California, United States
$180k-$211k/yr RemoteFull Time
10+ YOEBachelor's in a scientific discipline, minimum 10 years vaccine/biotech experience, experience authoring CMC sections (BLA preferred), IND/IMPD experience, development/manufacturing exposure, advanced regulatory knowledge, strong communication.
LIMS, SAP, TrackWise, Veeva
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Senior Manager, Regulatory CMC
Brisbane, California, United States
$140k-$214k/yr RemoteFull Time
6+ YOEBA/BS in a scientific field with minimum 6 years of regulatory affairs experience; strong US regulatory knowledge; CMC development in biologics preferred; proficient in regulatory information management systems (Veeva Vault RIM a plus).
Veeva Vault RIM
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Manager, Regulatory Affairs CMC
Foster City, California, United States
$147k-$190k/yr OnsiteFull Time
4+ YOEBachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline; 4–6+ years in pharmaceutical project, CMC development, or CMC Regulatory Affairs; Regulatory Affairs Certification a plus.
3mo
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Associate Director, Regulatory CMC
Palo Alto or Princeton or Miami
$194k-$199k/yr HybridFull Time
6+ YOEBachelor’s degree in chemistry, pharmacy, engineering, or biochemistry; 6+ years Regulatory CMC experience; experience with biologics; strong FDA/EU regulatory knowledge; experience preparing CMC submissions (IND/IMPD/BLA/MAA). Mandarin desirable.
Microsoft Word, Microsoft Excel, Document management systems
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Executive Director, CMC Diligence
San Diego or United States
$246k-$332k/yr HybridFull Time
10+ YOE6+ MgmtPh.D. or equivalent,10+ years CMC experience in pharma/biotech,6+ years people management,deep CMC expertise across modalities,knowledge of GMP,process validation,tech transfer,ability to synthesize technical risks for leadership.
Six Sigma
2w
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Senior Director, Regulatory CMC
South San Francisco, California, United States
$245k-$285k/yr HybridFull Time
10+ YOEBA/BS in a scientific field, 10+ years regulatory CMC experience in pharma/biotech, strong knowledge of biologics regulations, leadership and agency interaction experience; gene/cell therapy experience preferred.
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Executive Director, CMC QA
Novato or South San Francisco
$294k-$363k/yr HybridFull Time
15+ YOE10+ Mgmt15+ years in regulated pharma/biotech with CMC QA experience, 10+ years leadership, bachelor’s in relevant field (advanced degree preferred), deep GMP and regulatory knowledge, inspection and supplier oversight experience.
Veeva, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams, Microsoft Project
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Senior Director/ Director, CMC Regulatory Affairs
South San Francisco, California, United States
$220k-$300k/yr OnsiteFull Time
10+ YOE10+ years pharmaceutical CMC experience, degree in technical discipline or equivalent, strong CMC regulatory writing (M2/M3), eCTD familiarity, cGMP and global regulatory knowledge, and ability to lead cross-functional teams.
eCTD
4w
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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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Senior Director, Regulatory CMC
South San Francisco, California, United States
$260k-$295k/yr HybridFull Time
15+ YOE15+ years industry experience with ≥10 years in CMC regulatory for biologics; experience with mAb development, IND/BLA/MAA filings, GMP/ICH/FDA/EMA guidance, drug-device combination products, and building regulatory teams.
4d
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Associate Director, CMC Program Mgmt
South San Francisco, California, United States
$159k-$207k/yr OnsiteFull Time
12+ YOERequires BA/BS and 12+ years of relevant biotech, pharmaceutical, or CMO CMC experience, or master's degree with 10+ years. Requires CRO/CMO management, GMP experience, and project management expertise.
project management software
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Senior Manager, CMC Project Management
South San Francisco or United States
$150k-$170k/yr HybridFull Time
7+ YOE3+ MgmtBachelor's in life sciences (or equivalent), 7+ years project management experience in biotech with CMC exposure, 3+ years leading cross-functional teams, PMP preferred, CMC and clinical development knowledge, proficiency with Smartsheet, Microsoft Project, SharePoint, and Office; U.S. work authorization required.
Smartsheet, Microsoft Project, Microsoft SharePoint, Microsoft Office Suite
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Director, CMC Regulatory Affairs
San Francisco, California, United States
$196k-$273k/yr HybridFull Time
10+ YOEAdvanced degree, 10+ years pharmaceutical CMC regulatory experience including IND/CTA and BLA/MAA submissions, knowledge of FDA/EMA/ICH guidelines, Health Authority interactions, and strong presentation skills.
2w
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Director, CMC Process Chemistry
South San Francisco, California, United States
$206k-$254k/yr HybridFull Time
8+ YOEPhD+8 years or MSc+12 years in process chemistry/development, experience with DS/CMC across development phases, CDMO management, strong regulatory and quality knowledge, leadership and cross-functional collaboration.
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Associate Director, CMC Regulatory
Redwood City, California, United States
$186k-$233k/yr OnsiteFull Time
10+ YOE10+ years in pharma/biotech drug development with 5+ years global CMC regulatory; experience with IND, IMPD/CTA, NDA, MAA submissions; strong US/EU/APAC GMP regulatory knowledge.
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