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8 fresh jobs found
Sr. Manager, CMC Regulatory Affairs
Remote (US) BeiGene logo BeiGene
Technical Report Review CAPA Management GMP Regulations CMC Strategies Global Submissions SOP Authoring FDA Interactions Biologic Products CTA +34
Senior Full Time
USD 133K+
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Associate Principal Scientist - Device & Combination Product Container Closure Integrity (CCI) Lead
USA - New Jersey - Rahway MSD logo MSD
Pressure decay Laser headspace analysis Vacuum decay Dye ingress Helium leak detection High voltage leak detection Method validation Container closure integrity Mass extraction +64
Senior Mid Full Time
USD 135K+
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Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
USA - Pennsylvania - North Wales (Upper Gwynedd) MSD logo MSD
CMC regulatory strategies Regulatory CMC Health authorities CMC regulatory strategy BLA IND Virology Technology development Scientific Excellence +50
Senior Full Time
USD 181K+
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Principal Scientist, Engineering
USA - New Jersey - Rahway MSD logo MSD
Chroma Downstream processing Viral Clearance Performance qualification BLA MS Process Characterization Process Performance Therapeutics +65
Senior Full Time
USD 164K+
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Associate Principal Scientist, Biologics Analytical Research and Development (Onsite)
USA - New Jersey - Rahway MSD logo MSD
Lab Informatics Separations science Therapeutic proteins Quality attributes Laboratory automation Uplc Scientific publications GLP SEC +73
Senior Mid Full Time
USD 135K+
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Senior Principal Scientist, Cell Line Development
USA - New Jersey - Kenilworth MSD logo MSD
Genome editing Vector optimization CHO host cell engineering Mammalian culture Recombinant Transcriptomics IND Protein expression BLA +66
Senior Full Time
USD 164K+
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Principal Scientist, Cell Culture & Fermentation Sciences
USA - New Jersey - Rahway MSD logo MSD
Fermentation Sciences Fermentation Mathematical modeling Performance qualification Drug substance Mammalian cell culture IND Manufacturing Investigations Process Performance +89
Senior Full Time
USD 164K+
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Executive Director, Device Quality & Regulatory
USA - New Jersey - Rahway MSD logo MSD
QMSR Regulatory Submission Quality oversight Regulatory CMC Health authorities Device technology IND BLA Device development +66
Exec Senior Full Time
USD 243K+
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