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24 fresh jobs found

Associate Director, Quality Assurance
USA - New Jersey - Rahway, United States

Quality investigations Drug Product Manufacturing Preventive Actions Regulatory inspections Deviations Equipment qualification Quality Risk Management Formulation Materials Management +84

Senior Mid Full Time

USD 126K+

Sr. Scientist, Engineering
USA - Pennsylvania - West Point, United States

Manufacturing science Drug Product Manufacturing Spr Manufacturing investigations Biochemical engineering Life cycle management Regulatory Documentation Scale-down DOE +75

Senior Full Time

USD 114K+

Regulatory Affairs Director - Global Regulatory Lead
US - Illinois - Chicago - Field/Remote, United States

Evidence-Based Communication Pediatric Plan Marketing Applications Clinical Trial Applications Global Regulatory Strategy Regulatory Strategies Regulatory expertise Global regulations Obesity +37

Senior Full Time

USD 197K+

Summer internship - Global Commercial Supply Chain Summer Intern
Remote (US), United States

Pharmaceutical project management Employee stock purchase plan CMC Financial excellence Reporting tools Microsoft Project GMP Standard Operating Procedures Entrepreneurial Mindset +28

Entry Internship Full Time

USD 77K+

Senior Principal Scientist, Cell Line Development
USA - New Jersey - Rahway, United States

Genome editing Systems biology Cell line development Shooting Molecular techniques Protein expression Recombinant Synthetic Biology Transcriptomics +55

Senior Full Time

USD 187K+

Director, Fermentation Operation
USA - New Jersey - Rahway, United States

Fermentation process development Biocatalysis Protein Engineering Scientific strategy Downstream purification Microbial fermentation Expression Microbial Technology Innovation +61

Exec Senior Full Time

USD 169K+

Associate Director, Packaging Development Lead
USA - Pennsylvania - West Point, United States

Packaging engineering Packaging science Pharmaceutical packaging ISO Standards Quality by design QbD Small Molecules Pharmaceutical Development CMC +52

Senior Mid Full Time

USD 126K+

Sr. Specialist, Project Management - Drug Development (Hybrid)
USA - Pennsylvania - North Wales (Upper Gwynedd), United States

Vaccine Development Vaccine Tactical input integration Enterprise project management systems Clinical drug development PMO Alliance Management Biotech industry Drug development process +48

Senior Mid Full Time

USD 114K+

Regulatory Affairs Specialist
USA - New Jersey - Rahway, United States

Veeva submissions Common technical document Drug development process CMC Regulatory Affairs Pharmaceuticals Drug Development Chemistry Veeva +16

USD 75K+

Associate Principal Scientist, Upstream Development
USA - New Jersey - Rahway, United States

Multivariate Data Analysis Fed-Batch Processes Patent Strategies Simca Recombinant Proteins Bioreactor scale-up CHO Cell Biology Downstream process development Recombinant +88

USD 139K+

Director, Biologics and Biopharmaceutics
USA - New Jersey - Rahway, United States

Formulation Design Monoclonal Antibodies Disease mechanisms Biopharmaceutics GMP Compliance MAbs Drug-Device Combinations Sterile Product Development Scientific Methodology +119

Exec Senior Full Time

USD 164K+

Regulatory Affairs Director
Newport Beach, California, United States

CMC Submissions CMC GMP Regulatory Affairs Biotechnology Pharmaceutical Industry Pharmaceutical Planning Attention to detail +4

Exec Senior Full Time

USD 200K+

Director/Consultant Regulatory Affairs
CAN - ON - Remote, Canada

AmerisourceBergen

EMA Health Canada CMC Adobe Acrobat ICH Mathematical Biologics Regulatory Affairs FDA +41

Exec Senior Full Time

CAD 133K+

AVP, Global Clinical Supply
USA - Pennsylvania - West Point, United States

Program Leadership Clinical trial execution Drug product development Clinical supply chain Clinical Supply Clinical supplies CGMP Pharmaceutical Sciences Collaborative relationships +60

Exec Senior Full Time

USD 276K+

Associate Prin. Scientist, Engineering
USA - New Jersey - Rahway, United States

Fermentation sciences Manufacturing investigations Mammalian Cell Culture Drug substance commercialization Bioprocess Fermentation Computational Fluid Dynamics Good manufacturing practice Performance qualification +99

Senior Mid Full Time

USD 139K+

Regulatory Affairs Director - Inflammation and Rare Disease
US - California - Thousand Oaks - Field/Remote, United States

Marketing Applications Clinical Trial Applications Orphan Drug Designation Fast Track Approval Pediatric Plan Global Regulatory Strategy Regulatory Strategies Regulatory expertise Global regulations +35

Exec Senior Full Time

USD 188K+

Executive Director, Engineering
USA - New Jersey - Rahway, United States

Technical product leadership Organizational transformation Drug substance Development and commercialization Drug product CMC Scientific Expertise Strategic Insights Project Execution +63

Exec Senior Full Time

USD 227K+

Senior Scientist, Supply Analytical Sciences - API Supply
USA - New Jersey - Rahway, United States

Icp-ms Gc-ms Cmc filing Karl fischer LC/MS Good manufacturing practice GC Spectroscopy Drug Products +39

Senior Full Time

USD 114K+

Sr. Specialist, Clinical Supplies Project Manager - Protocol (Hybrid)
USA - New Jersey - Rahway, United States

Clinical supply chain Document Control Good clinical practices Manufacturing Practices Clinical Supply Good Manufacturing Practices Clinical supplies Supply Planning Tactical Execution +73

Senior Mid Full Time

USD 114K+

Sr. Specialist, Clinical Supply Project Manager - Inventory Manager (Hybrid)
USA - New Jersey - Rahway, United States

Microsoft PowerApps Clinical supply chain Document Control IRT Good clinical practices Clinical Supply Manufacturing Practices Good Manufacturing Practices Clinical supplies +69

Senior Mid Full Time

USD 114K+

Director Large Molecule Development
USA - New Jersey - Rahway, United States

Monoclonal Antibodies Bioprocess Drug-Device Combinations Molecule Development MAbs Chemical Fusion proteins Drug product development Antibodies +109

Exec Senior Full Time

USD 169K+

Principal Scientist/Director, Regulatory Affairs-CMC (Chemistry, Manufacturing & Controls)
USA - New Jersey - Rahway, United States

Drug-Device Combinations NDA Chemical MAA CTA BLA Design control Health authorities Acquisitions +55

Senior Full Time

USD 181K+

Director, Comparator Sourcing
Remote (US), United States

Clinical supply chain Cross-cultural communication Drug development process CGMP CAPA CMC ICH Clinical Studies Clinical operations +35

Exec Senior Full Time

USD 161K+

Executive Director, Regulatory Affairs - Cell Medicine
Remote - United States, United States

NDA CTA BLA Gene therapy IND CMC Cell Therapy Biologics Regulatory Submissions +12

Exec Senior Full Time

USD 251K+

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