1mo
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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
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
2mo
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Food Safety and Quality Assurance Manager (Milford, DE, US, 19963)
Milford, Delaware, United States
OnsiteFull Time
5+ YOE5+ MgmtLead FSQA department, develop and enforce safety/quality processes, ensure regulatory compliance, partner with FDA/USDA, travel as needed.
2w
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Supervisor Production
Bridgeville, Delaware, United States
OnsiteFull Time
4+ YOE1+ MgmtLead production teams, manage scheduling and performance, ensure compliance with FDA/USDA and safety rules, apply LEAN, use production reports, and be proficient with Microsoft Office.
Microsoft Office
1w
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Phlebotomist
Newark, Delaware, United States
OnsitePart Time
1+ YOEPerform venipuncture and plasmapheresis, monitor donors and equipment, document donor data, follow SOPs and FDA guidelines; high school diploma and 12 months medical experience preferred.
Personal Digital Assistant (PDA), Standard Operating Procedures (SOPs), Food & Drug Administration (FDA), Electronic donor information management system
3d
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Product Quality Engineer 1
Newark, Delaware, United States
$55k-$86k/yr OnsiteFull Time
0+ YOEBachelor’s in engineering, 0-2 years experience, familiarity with FDA QSR/ISO 13485 and risk management, root cause analysis, complaint investigation, and cross-functional CAPA implementation.
2mo
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Lead Medical Science Liaison, Molecular Imaging (Mid-Atlantic)
Delaware or District of Columbia or Atlanta or Georgia or Maryland or North Carolina or Pennsylvania or South Carolina or Virginia or West Virginia
$169k-$253k/yr FieldFull Time
2+ YOEBachelor's degree, valid driver\u0002s license, 2+ years industry experience, strong presentation and communication skills, working knowledge of FDA and OIG requirements; MSL certification and conference experience preferred.
1mo
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Driver - Delivery Technician - New Castle, DE
New Castle, Delaware, United States
$23-$25/hr OnsiteFull Time
1+ YOEHigh school diploma or equivalent, 1+ year related experience, minimum three years driving history, valid driver’s license, completion of driver training program, DOT/FDA compliance, English proficiency.
1w
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EHS Specialist
Newark or Wilmington or Spring House
$82k-$110k/yr HybridFull Time
7+ YOEBachelor's in a scientific field, minimum 7 years EHS experience in pharmaceutical or industrial settings, strong knowledge of FDA/OSHA/EPA/ICH/GDP/DNREC/PADEP regs, strong communication and problem-solving skills.
1mo
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Lead Medical Science Liaison, Molecular Imaging (Mid-Atlantic)
West Virginia or Pennsylvania or Georgia or Atlanta or Virginia or South Carolina or North Carolina or Maryland or Delaware or District of Columbia
$169k-$253k/yr FieldFull Time
2+ YOEBachelor's degree required, 2+ years industry experience, strong presentation and communication skills, valid driver’s license, working knowledge of FDA and OIG requirements; advanced degree and 3+ years MSL experience preferred.
2w
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Specialty Gas Filler/Lab Technician - New Castle
New Castle, Delaware, United States
OnsiteFull Time
2+ YOEPerform specialty gas cylinder filling and testing per DOT/FDA/industry standards; forklift operation; attention to detail and safety; ability to lift up to 75 lb; Associate degree or 2 years relevant experience preferred.
Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft Access
6d
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EHS Specialist
Newark or Wilmington or Spring House
$82k-$110k/yr OnsiteFull Time
7+ YOEBachelor of Science in a scientific field, 7+ years EHS experience in pharmaceutical or industrial settings, knowledge of FDA/OSHA/EPA and regional regulators, respirator use, strong communication and problem-solving skills, legally eligible to work in the USA.
1mo
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Director / Associate Director Companion Diagnostics Lead, Translational Sciences
Wilmington, Delaware, United States
OnsiteFull Time
7+ YOEBS in a scientific discipline with 7+ years in diagnostics or pharmaceutical industry; experience with CDx strategy, vendor management, assay evaluation (NGS, PCR, IHC), regulatory knowledge (US FDA, EU IVDR), GCP familiarity, and strong communication.
Next Generation Sequencing, PCR, Immunohistochemistry
1mo
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Plant Engineer
Wilmington, Delaware, United States
OnsiteFull Time
1+ YOEBachelor's in science/engineering/pharmaceutical, 1–5 years chemical or pharmaceutical manufacturing, cGMP experience (ISO 9001, FSSC22000, IPEC, or FDA QMS), ability to respond to site emergencies, support Allen-Bradley PLC, support audits.
Allen-Bradley PLC
2mo
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Production Worker I
Milford, Delaware, United States
OnsiteFull Time
Operate and maintain production and packaging equipment, perform filling/labeling/inspection/packaging, follow SOPs/GMP/FDA/QA, read safety and procedure documents, perform basic math; HS/GED preferred and 6 months production experience preferred.
scales, hand jacks, powered jacks, statistical process control
1mo
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Clinical Engagement Lead - Northeast
United States or Connecticut or District of Columbia or Delaware or Indiana or Massachusetts or Maryland or Maine or Michigan or New Hampshire or New Jersey or New York or Ohio or Pennsylvania or Rhode Island or Vermont
$180k-$235k/yr FieldFull Time
8+ YOEBachelor's degree required (advanced degree preferred), 8+ years clinical development/field-based experience, proven investigator relationship management, immunology experience preferred, GCP/ICH/FDA knowledge, valid US driver's license, ability to travel 50%+ and work evenings/weekends.
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