New York City • 50 milesRemote · Hybrid · Onsite · Field · All Environments
New York City • 50 milesRemote · Hybrid · Onsite · Field · All Environments
New York City • 50 milesRemote · Hybrid · Onsite · Field · All Environments
New York City • 50 milesRemote · Hybrid · Onsite · Field · All Environments
73 cmc jobs at 39 companies in New York City, NY
1w
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Manager, Regulatory CMC
Somerset or Bridgewater
$127k-$167k/yr HybridFull Time
5+ YOEBachelor's degree in a relevant life science or engineering field, 5+ years of biotechnology or pharmaceutical experience, and 1–2 years of Regulatory CMC experience. Strong technical writing, scientific analysis, project management, and collaboration skills required.
CAR-T, TCR-T, NK, IND, CTA, BLA, MAA, FDA, EMA, ICH, E-Verify, Form I-9
2mo
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Director, Regulatory CMC - Cell Therapy
Madison, New Jersey, United States
$200k-$242k/yr OnsiteFull Time
10+ YOEBA/BS required; minimum 10 years pharmaceutical experience with 8+ years regulatory CMC experience. Experience preparing CMC submissions, developing global regulatory strategy, leading teams, and using regulatory information systems.
Regulatory Information Management system
1w
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Director, Regulatory Affairs CMC
Pleasanton or Princeton
$213k-$250k/yr HybridFull Time
15+ YOEBachelor's degree in pharmacy, chemistry, or related science; 15 years of CMC drug development and regulatory experience, including 8–10 years in CMC regulatory work; global submission and regulatory strategy expertise.
FDA, EMA, Good Manufacturing Practices (GMP), Chemistry, Manufacturing and Controls (CMC), current Good Manufacturing Practices (cGMP)
1mo
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Director, Regulatory Affairs CMC
New York or Houston or United States
RemoteFull Time
10+ YOEBachelor's in life sciences required; 10+ years CMC regulatory experience with 5+ years in gene therapy/biologics, BLA experience, global CMC submission leadership, regulatory strategy and health authority interaction experience.
2mo
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Director, Regulatory CMC - Cell Therapy
Madison, New Jersey, United States
$200k-$242k/yr OnsiteFull Time
10+ YOEBA/BS required; 10+ years pharmaceutical experience with 8+ years regulatory CMC experience; knowledge of CMC for advanced/cell therapies; ability to develop regulatory strategy, lead teams, interact with health authorities, and use electronic regulatory systems.
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
4d
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Senior Director, CMC Regulatory
Princeton, New Jersey, United States
$241k-$300k/yr HybridFull Time
10+ YOEBachelor’s degree in a scientific discipline, 10+ years of industry experience, and expertise in CMC regulatory affairs, global submissions, health authority interactions, and FDA, EMA, and ICH requirements.
FDA, EMA, ICH
1mo
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Senior Manager / Associate Director, Regulatory Affairs CMC
Florham Park, New Jersey, United States
$140k-$200k/yr HybridFull Time
5+ YOEDevelop and execute global CMC regulatory strategies, author submission-ready CMC content, interface with health authorities, and lead cross-functional teams; BSc in a scientific discipline and 5+ years CMC regulatory experience.
Veeva Vault, eCTD, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
2w
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Director, CMC – Biologics & ADC
New York City, New York, United States
$210k-$250k/yr HybridFull Time
8+ YOEPh.D. or equivalent experience, 8–10+ years of biopharmaceutical CMC experience, antibody process development, ADC manufacturing, oncology drug development, CDMO management, GMP manufacturing, and regulatory submissions.
AI, AI/ML, Protein A, BLA, MAA, IND, IMPD, FDA, EMA, ICH, GMP
1mo
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Head of Biologics Development & CMC
New York, New York, United States
$170k-$230k/yr OnsiteFull Time
10+ YOEPh.D. (10+ years) or M.S. (13+ years) or B.S. (15+ years) in related field; deep biologics and downstream/process/analytical experience; product characterization and regulatory CMC leadership; experience managing scientists and external partners.
5d
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Director, Regulatory Affairs CMC
Princeton or San Diego or South San Francisco
$190k-$237k/yr HybridFull Time
10+ YOE5+ MgmtBachelor’s degree in life science or related field, 10 years of CMC Regulatory Affairs experience in small-molecule drug development, and 5 years in management; global filings and regulatory strategy expertise required.
2mo
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Associate Director, Regulatory Affairs - CMC
Warren, New Jersey, United States
$169k-$213k/yr HybridFull Time
7+ YOEBachelor's in science, 7+ years regulatory affairs/CMC writing experience in pharma/biotech, small-molecule CMC expertise, GMP knowledge, ICH/regulatory guidance familiarity, Microsoft Office proficiency, up to 10% travel.
Microsoft Office, eCTD
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Associate Director, CMC Regulatory Affairs
Paramus, New Jersey, United States
$170k-$190k/yr HybridFull Time
8+ YOEBachelor in pharmacy/chemistry or equivalent; typically 8+ years in CMC with minimum 5 years in CMC regulatory affairs. Strong FDA/ICH knowledge, eCTD/CTD experience, technical writing, project management, and excellent English communication.
eCTD, CTD
2w
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Assoc. Dir, Regulatory Affairs-CMC
Rahway or North Wales
$142k-$224k/yr HybridFull Time
5+ YOEBS or equivalent scientific, technical, or regulatory degree; 5+ years in pharmaceutical or biotech Regulatory CMC; hands-on digital, automation, and AI/LLM experience; change management, mentoring, collaboration, and project coordination skills.
Artificial Intelligence (AI), machine learning, generative AI, AI/LLM, Electronic Common Technical Document (eCTD), Veeva, ERA App
2mo
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Director, CMC Commercial Planner
Hampton, New Jersey, United States
$177k-$229k/yr OnsiteFull Time
12+ YOEBachelor's in related field required; 12+ years pharma/biotech supply chain or commercial planning experience with leadership responsibility; experience with launches, CDMO/vendor management, inventory and capacity planning, S&OP/IBP.
ERP systems, planning tools, Sales & Operations Planning (S&OP), Integrated Business Planning (IBP)
2w
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Manufacturing Consultant - Life Sciences - Digital CMC / PLM
Akron or Albany or Arlington or Atlanta or Austin or Beaverton or Bentonville or Boston or Carmel or Charlotte or Chicago or Cincinnati or Columbus or Denver or Detroit or Hartford or Houston or Irving or Kirkland or Miami or Milwaukee or Minneapolis or Morristown or Nashville or New York City or Overland Park or Philadelphia or Pittsburgh or Raleigh or San Francisco or Seattle or St. Louis or St. Petersburg or United States
$54k-$206k/yr FieldFull Time
3+ YOE3+ years in life sciences supply chain and manufacturing consulting, with digital CMC/PLM, material flow, manufacturing engineering, and transformation experience; bachelor's degree or equivalent required.
PLM, CMC, knowledge graphs, data lineage, AI, ERP, Distributed Control System (DCS), PLC, SCADA, Human-Machine Interface (HMI), 2D/3D simulations, automated mobile robots (AMRs)
1w
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Computational Modeling Consultant - CMC
Chicago or Evanston or New York City or Princeton or Philadelphia or Boston
$160k-$177k/yr HybridFull Time
5+ YOEBachelor's, master's, or PhD in a relevant scientific or engineering discipline; 5+ years of relevant experience; expertise in mechanistic modeling, AI/ML, programming, pharmaceutical CMC, and scientific data systems.
CFD, DEM, AI/ML, ELN, LIMS, ERP, PLM
2w
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Manufacturing Consultant - Life Sciences - Digital CMC / PLM
Atlanta or Milwaukee or Akron or Dallas or Columbus or Kirkland or Cincinnati or New York City or Austin or Albany or Chicago or St. Petersburg or Hartford or Pittsburgh or St. Louis or Miami or Raleigh or Minneapolis or Mountain View or Morristown or Denver or Boston or Philadelphia or Des Moines or Overland Park or Los Angeles or Charlotte or Carmel or Houston or Arlington or Bentonville or Nashville or Detroit
$59k-$206k/yr HybridFull Time
3+ YOERequires 3+ years in life sciences supply chain or manufacturing consulting, digital CMC and PLM experience, manufacturing engineering exposure, and familiarity with ERP, DCS, PLC, SCADA, HMI, and factory simulation.
PLM, PFEP, ERP, Distributed Control System (DCS), PLC, SCADA, HMI, 2D simulations, 3D simulations, IT/OT
1w
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Principal Scientist, CMC Regulatory Affairs - Combination Products
Raritan or Horsham or Titusville or Spring House or United States or Belgium or Poland or Switzerland or Europe
$117k-$201k/yr HybridFull Time
8+ YOEBachelor’s degree and 8+ years of relevant regulatory, quality, or product development experience in a regulated healthcare environment; combination product expertise and global regulatory experience preferred.
1w
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Principal Scientist, CMC Regulatory Affairs - Combination Products
Raritan or Horsham or Titusville or Spring House
$117k-$201k/yr HybridFull Time
8+ YOEBachelor’s degree required; 8+ years in regulatory affairs, quality, or product development in a regulated healthcare environment. Requires global combination-product expertise, strategy development, and cross-functional communication.
21 CFR Part 4, Quality Management System Regulation (QMSR), EU Medical Device Regulation (EU MDR)
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