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29 fresh jobs found

Senior Director, Digital Program Manager, Development Sciences and Clinical Supply
USA - New Jersey - Rahway

Drug substance development Clinical Supply Management Drug product development Process research Analytical Development Clinical Supply Drug substance Value Realization Analytical Research +50

Senior Full Time

USD 164K+

Principal Scientist, Biophysical Characterization
USA - New Jersey - Rahway

Protein science Biotherapeutics characterization Protein-protein interactions Protein stability Peptide Biotherapeutics Biophysics Development and commercialization Formulation Development +55

Senior Full Time

USD 149K+

Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
USA - Pennsylvania - North Wales (Upper Gwynedd)

CMC regulatory strategies Regulatory CMC Health authorities CMC regulatory strategy BLA IND Virology Technology development Scientific Excellence +50

Senior Full Time

USD 181K+

Director, Product Line Technical Lead, Composition of Matter
USA - New Jersey - Rahway

Technology vision Architectural alignment Pharmaceutical experience Tech Transfer Life cycle management Experiment Design Clinical supplies Computational Technology Trends +64

Senior Full Time

USD 164K+

Senior Specialist, Clinical Supply Project Manager - Protocol (Hybrid)
USA - Pennsylvania - West Point

Supply chain documentation Supply Chain Systems Clinical supply chain Good Manufacturing Practices Good clinical practices Tactical Execution Manufacturing Practices Clinical Supply Clinical supplies +74

Senior Full Time

USD 111K+

Regulatory Affairs Director - Global Regulatory Leader (General Medicine/Cardiovascular)
US - California - Thousand Oaks - Field/Remote

Product Labeling Clinical trial applications Marketing Applications Regulatory expertise Global Regulatory Strategy Global regulations Life cycle management Regulatory Guidance Registration +32

Senior Full Time

USD 188K+

Regulatory Affairs Director - Global Regulatory Lead
US - California - Thousand Oaks - Field/Remote

Data Sheet Development Clinical trial applications Product Labeling Marketing Applications Global Regulatory Strategy Regulatory expertise Obesity Global regulations Life cycle management +35

Senior Full Time

USD 188K+

Director, Biologics VCM Product Leader
USA - Pennsylvania - West Point

Large molecule operations Cost projections Launch strategy Development and commercialization Value Stream Mapping Large Molecule Commercial operations Regulatory strategy Manufacturing operations +76

Senior Full Time

USD 164K+

Director, Small Molecule Analytical Research and Development
USA - New Jersey - Rahway

GMP knowledge Quality system experience Development and commercialization Analytical Method Development Analytical methodologies Scientific Methodology FDA guidelines Drug substance Formulation Development +61

Exec Senior Full Time

USD 164K+

Assoc. Dir., Biologics VCM Product Manager
USA - Pennsylvania - West Point

Large molecule operations Launch strategy Value Stream Mapping Large Molecule Commercial operations Regulatory strategy Manufacturing operations Commercial Strategy Change Control +73

USD 122K+

Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

In-process controls Drug Product Commercialization Facility fit Shelf-life strategies Packaging strategy Site characterization Multivariate analysis CMC regulatory strategy Manufacturing science +85

Senior Full Time

USD 164K+

Grad Intern - Global Regulatory Affairs CMC
US - California - Thousand Oaks - Field/Remote

Pharmaceutical science Synthetic chemistry Protein Biochemistry Organic chemistry Cell Biology Scientific Knowledge Pharmacology Microbiology CMC +22

Entry Internship Full Time

USD 80K+

Associate Principal Scientist (Computational), Process & Product Modeling - Large Molecules
USA - Pennsylvania - West Point

Engineering models Data driven models Metabolomics Population balance models Model-based process controls Chromatography modeling Computational modeling Bioreactor kinetics Chemical kinetics +73

Senior Mid Full Time

USD 135K+

Principal Scientist, Oral Formulation Sciences, PSCS
USA - New Jersey - Rahway

Formulation science Technical Mentoring Organic chemistry Biopharmaceutics Manufacturing Process Life cycle management Formulation Development Materials science GMP manufacturing +62

Senior Full Time

USD 149K+

Regulatory Affairs Director - Oncology
US - California - Thousand Oaks - Field/Remote

Agency communication Clinical trial applications Global Regulatory Strategy Marketing Applications Regulatory expertise Life cycle management Global regulations Regulatory Guidance Regulatory strategy +26

Exec Senior Mid Full Time

USD 188K+

Senior Manager, Regulatory Affairs, CMC
Remote (US)

EU Regulatory Requirements Technical Document Authoring Microsoft 360 ICH Requirements US Regulatory Requirements Regulatory strategy Protocols CMC Financial excellence +23

Senior Full Time

USD 133K+

Global Program Manager
US - California - Thousand Oaks - Field/Remote

Dai principles Life cycle management Leadership Attributes Product Lifecycle PLM Project Scheduling CMC Lifecycle Management MS Project +39

USD 113K+

Senior Principal Scientist, Cell Line Development
USA - New Jersey - Kenilworth

Genome editing Vector optimization CHO host cell engineering Mammalian culture Recombinant Transcriptomics IND Protein expression BLA +66

Senior Full Time

USD 164K+

Principal Scientist, Cell Culture & Fermentation Sciences
USA - New Jersey - Rahway

Fermentation Sciences Fermentation Mathematical modeling Performance qualification Drug substance Mammalian cell culture IND Manufacturing Investigations Process Performance +89

Senior Full Time

USD 164K+

Director, Engineering
USA - New Jersey - Rahway

Technical product leadership Development and commercialization Innovative problem-solving Commercialization strategy Pharmaceutical manufacturing Drug product Tech Transfer Innovative Thinking Scientific Expertise +53

Exec Senior Full Time

USD 164K+

Associate Principal Scientist, Sterile Drug Product Commercialization
USA - Pennsylvania - West Point

Scale-Up Processes Drug Product Commercialization Characterization Studies Life cycle management CMC regulatory strategy Performance qualification QbD principles Manufacturing science Process Performance +93

Senior Mid Full Time

USD 135K+

Director, Analytical External Capabilities, Validation & Compliance (ECVC)
USA - New Jersey - Rahway

Analytical Method Development Biochemical Characterization Biologics development Drug product Biophysical characterization Analytical Development Budget Forecasting Method development Biologic +41

Exec Senior Full Time

USD 164K+

Principal Scientist - Mixed Modalities, Sterile Product Development
USA - New Jersey - Rahway

Parenteral dosage forms Formulation science DOE studies QbD principles Drug product development Intermediate modalities Parenteral drug products Drug product Equipment design +71

Senior Full Time

USD 149K+

Executive Director, Biologics Analytical Research and Development
USA - New Jersey - Rahway

Microbiological techniques Uplc Cell based analytics Separations science Quality attributes ELISA SEC Analytical Development Disease mechanisms +66

Exec Senior Full Time

USD 243K+

Executive Director, Device Quality & Regulatory
USA - New Jersey - Rahway

QMSR Regulatory Submission Quality oversight Regulatory CMC Health authorities Device technology IND BLA Device development +66

Exec Senior Full Time

USD 243K+

Principal Scientist, Engineering
USA - Pennsylvania - West Point

Intravitreal product development Performance qualification Site characterization Manufacturing Investigations Packaging strategy Shelf-life strategies CMC regulatory strategy Multivariate analysis Tech Transfer +79

Senior Full Time

USD 164K+

Associate Principal Scientist, Engineering
USA - Pennsylvania - West Point

Manufacturing Investigations Scale-down QbD Current good manufacturing practices Tech Transfer Regulatory Filing Process Characterization DOE Process Validation +83

Senior Mid Full Time

USD 135K+

Associate Principal Scientist, Downstream Biologics Process R&D
USA - New Jersey - Rahway

Downstream Purification Viral Clearance Continuous Processing Crystallization Purification processes Multivariate data analysis Automation platforms Biochemical engineering Protein purification +70

USD 135K+

Clinical Supply Chain Manager
Remote (US)

Drug supply management Label development Irt systems IRT Clinical Study Protocols Clinical supply chain CMC Protocols Financial excellence +29

USD 106K+

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