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31 fresh jobs found

Contract Manufacturing Manager (Oligonucleotides, Peptides)
US - California - Thousand Oaks - Field/Remote, United States

Synthetic therapeutics Outsourcing management Radiolabeling Clinical manufacture Supplier evaluation Financial Forecasting CMC Quantitative Project leadership +36

Senior Full Time

USD 114K+

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

Technical strategies Continuous manufacturing Biomanufacturing technologies Downstream bioprocessing Biologics CMC development Purification processes Research and innovation Scientific publishing High-throughput experimentation +81

Senior Full Time

USD 149K+

Senior Principal Scientist, Upstream Biologics Process R&D
USA - New Jersey - Rahway, United States

Bioreactor scale-up Microbial fermentation Downstream bioprocessing Fermentation Biologics CMC development Research and innovation Recombinant Biomanufacturing High-throughput experimentation +81

Senior Full Time

USD 164K+

Senior Principal Scientist, Preclinical Development
USA - New Jersey - Rahway

Downstream bioprocessing Purification processes Biologics CMC development Research and innovation Biomanufacturing Digitalization Sustainable processes Project Strategy Downstream processing +72

Senior Full Time

USD 164K+

Director, Engineering
USA - New Jersey - Rahway

Technical product leadership Commercialization strategy Innovative problem-solving Tech Transfer Development and commercialization Scientific Excellence Innovative Thinking Drug product CMC +49

Exec Senior Full Time

USD 164K+

Associate Director, Project Management, Chemistry Manufacturing Controls (CMC) - Hybrid
USA - Pennsylvania - North Wales (Upper Gwynedd)

Chemistry Manufacturing Controls Chemistry Manufacturing Vaccine Development Clinical drug development Development and commercialization PharmD CMC MS Commercialization +44

Senior Mid Full Time

USD 135K+

Manager, Commercial Supply Chain
Remote (US)

Warehousing technologies Ariba SAP ERP Regulatory Guidelines CMC GMP Financial excellence Entrepreneurial Mindset Office +30

USD 106K+

Associate Director, Global Regulatory Lead
Remote (US)

CTA Submission documentation Global regulatory environment Global Regulatory Requirements Marketing Approval Health Authority Interactions Drug development process Global Regulatory Strategy BLA +41

Senior Mid Full Time

USD 142K+

Associate Director, Project Management - Drug Development (Hybrid)
USA - Pennsylvania - North Wales (Upper Gwynedd)

Enterprise project management systems Vaccine Development Biotech industry Clinical drug development PharmD MS Business Process Improvement CMC Cross-functional Team Leadership +41

USD 135K+

Senior Manager, RIM Business Process Driver
Remote (US)

IDMP RIM Regulatory Technology PQ-CMC SPOR DADI Data Quality Standards ECTD SPL +49

Senior Full Time

USD 132K+

Principal Scientist, Analytical R&D
USA - New Jersey - Rahway

Enzymology Bioanalytical assays Bioanalytical methodologies Scientific strategy Biocatalysis Protein Engineering SEC Analytical methodologies CE +49

Senior Full Time

USD 149K+

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

Sterile Products Antibody-drug conjugate In-process controls Drug Product Commercialization Facility fit Analytical Technologies Manufacturing science Shelf-life strategies Multivariate analysis +101

Senior Mid Full Time

USD 135K+

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

Continuous process optimization Antibody-drug conjugate In-process controls Facility fit Manufacturing science Analytical Technologies Drug Product Commercialization Shelf-life strategies Scale-down +100

Senior Full Time

USD 164K+

Director, Quality Assurance (New Modalities)
USA - Pennsylvania - North Wales (Upper Gwynedd)

Personalized Therapies Quality oversight Current good manufacturing practices Good Manufacturing Practices QMS Manufacturing Practices Technical Operations Quality Management Systems Regulatory filings +45

Exec Senior Full Time

USD 164K+

Director, Small Molecule VCM Product Leader
USA - New Jersey - Rahway

Product supply strategies Operations knowledge Cost projections Pharmaceutical operations Financial stewardship Launch strategy Development and commercialization Value Stream Mapping Manufacturing operations +72

Senior Full Time

USD 164K+

Director, Project Management, Chemistry Manufacturing & Controls (CMC) - Hybrid
USA - Pennsylvania - North Wales (Upper Gwynedd)

Chemistry Manufacturing Vaccine Development Biologics development Development and commercialization Clinical drug development PharmD MS CMC Operational Support +48

Exec Senior Full Time

USD 149K+

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+

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+

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+

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+

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+

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+

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+

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