2w
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Principal Scientist
Cherry Hill, New Jersey, United States
$118k-$135k/yr OnsiteFull Time
10+ YOEBS in Chemistry (advanced degree preferred), 10+ years pharmaceutical/analytical lab experience, method development/validation leadership, expertise in HPLC/UPLC/GC/dissolution/UV/FTIR and cGMP/ALCOA+/FDA/ICH/USP/EP, strong technical writing and communication.
HPLC, UPLC, GC, Dissolution, UV, FTIR, cGMP, ALCOA+, FDA, ICH, USP, EP
2mo
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Director Promotional Regulatory Affairs
Wilmington, Delaware, United States
HybridFull Time
5+ YOEBachelor's in science required; 5+ years total pharma/biotech/FDA experience with 3+ years in promotional regulatory affairs or OPDP/APLB; strong knowledge of FDA promotional regulations, drug development, and labeling; experience engaging FDA.
AZAP
1mo
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Associate Director, REMS Operations (68770)
Parsippany or West Chester or United States
$159k-$194k/yr HybridFull Time
7+ YOEBachelor's degree, 7+ years program/project management in regulated industry (preferably pharma), 2+ years working with FDA, vendor management, FDA/REMS regulatory expertise, MS365 skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, MS Project, MS365, database
3mo
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Assistant Quality Unit Manager
Gibbstown, New Jersey, United States
$70k-$90k/yr OnsiteFull Time
5+ YOEMinimum 5 years’ related experience; knowledge of FDA CFR 210/211, cGMP Pharma; FDA CFR 820 / ISO 13485 cGMP Medical Device;Bachelor’s in technical/science.
ERP/MRP, QMS
3w
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Director Promotional Regulatory Affairs
Gaithersburg or Wilmington
HybridFull Time
5+ YOEBachelor's in science,3+ years promotional regulatory experience,5+ years total pharma/biotech experience,knowledge of FDA OPDP/APLB and labeling,ability to lead MLR and engage with FDA.
AZAP
2w
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Risk Management Associate I
Malvern, Pennsylvania, United States
$75k-$85k/yr OnsiteFull Time
4+ YOEBachelor's in life sciences, 4+ years in FDA-regulated industry with quality/regulatory compliance experience; knowledge of ISO 13485/14971 and FDA QSR; strong communication, leadership, project and database skills.
1mo
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Associate Director, REMS Operations
Parsippany or West Chester
$159k-$194k/yr HybridFull Time
7+ YOE2+ MgmtBachelor's degree, 7+ years program/project experience in regulated industry (pharma preferred), 2+ years interacting with FDA, vendor and budget management, FDA regulatory knowledge, MS Office and project tools proficiency, leadership experience.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Project, Microsoft 365
5d
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Director, Operations
Cherry Hill, New Jersey, United States
OnsiteFull Time
8+ YOEBS in engineering or life sciences required (MS/MBA preferred); 8+ years FDA-regulated pharmaceutical manufacturing experience, sterile injectable experience preferred; strong cGMP, FDA inspection, aseptic process, leadership, budgeting, and continuous improvement skills.
Lean, Six Sigma
2mo
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Senior Process Architect
Blue Bell, Pennsylvania, United States
HybridFull Time
10+ YOE10+ years in process architecture; cGMP planning; FDA/EU/regulatory knowledge; Revit; MS Office; strong communication; travel.
Revit, MS Office
2mo
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Director--Operations
Audubon, Pennsylvania, United States
OnsiteFull Time
10+ YOE10+ MgmtBachelor’s in Life Sciences or Engineering; 10+ yrs supervisory/production exp; strong leadership; FDA experience; CI/OEE focus.
ERP systems, Opex
2w
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International Regulatory Specialist
Audubon, Pennsylvania, United States
OnsiteFull Time
5+ YOEBachelor's in engineering or science,5 years related experience,experience with US FDA and international regulatory requirements and EU MDR technical documentation.
2mo
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Director of Quality (Exton, PA, US, 19341)
Exton, Pennsylvania, United States
HybridFull Time
10+ YOE10+ years in FDA-regulated quality with multi-site leadership; governance of change control/document management; matrix leadership; external customer interface.
Excel, PowerPoint, QMS, Lean, Six Sigma, CAPA
2mo
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Site Engineering Lead
King of Prussia, Pennsylvania, United States
OnsiteFull Time
10+ YOE2+ MgmtBachelor’s degree in engineering; 10+ years in regulated manufacturing; 2+ years managing technical staff; experience delivering capital projects; FDA/EMA inspections.
Automation, Controls, Plant Control Systems
5d
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BATCHING TECHNICIAN (3572)
Millville, New Jersey, United States
$22/hr OnsiteFull Time
1+ YOEFollow batch recipes and SOPs, operate mixing and batching equipment, perform quality checks, maintain production records, and comply with GMP/HACCP/FDA standards.
2mo
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Senior Associate, Regulatory Affairs
Philadelphia or San Francisco
OnsiteFull Time
2+ YOEBachelor’s in life sciences; 2+ years Regulatory Affairs in biotech/pharma; oncology/IND experience; strong communication; regulatory submissions; FDA/ICH knowledge.
2mo
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AD/ Director, Clinical Regulatory Affairs Gene Therapy
Malvern, Pennsylvania, United States
OnsiteFull Time
8+ YOEBachelor’s or Master’s in life sciences; 8+ years regulatory affairs in biotech/pharma with gene therapy; FDA interactions; INDs/CTAs/BLAs; cross-functional collaboration.
1w
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Senior Quality Lead
Malvern or Spring House
HybridFull Time
6+ YOEBachelor's in a scientific/engineering field, 6+ years in regulated manufacturing, working knowledge of cGMP and FDA/EU guidance, inspection readiness, strong communication and analytical skills.
1w
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Merchandising Brand Associate
West Chester, Pennsylvania, United States
HybridFull Time
2+ YOEBachelor's degree and 2+ years experience; familiarity with FTC/FDA guidance preferred; vendor management, product onboarding, claims/storytelling experience and cross-functional collaboration.
1w
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Sanitation Area Manager Northeast Region
Upper Darby, Pennsylvania, United States
FieldFull Time
7+ YOE7+ Mgmt7+ years management in food manufacturing sanitation, knowledge of USDA/FDA regulations, GMPs, LOTO, HAZCOMM, bilingual Spanish/English, proficiency with Microsoft Office and Google Workspace.
Microsoft Office, Google Workspace
1mo
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Mammography Coordinator Full-time Days / Cherry Hill
Cherry Hill, New Jersey, United States
$41-$63/hr OnsiteFull Time
3+ YOE3+ years mammography technologist experience, graduate of accredited radiology technology program, ARRT certification and NJDEP licensure required; knowledge of MQSA/FDA standards; CPR desired.