Lead Biologics CMC Regulatory Scientist
Scorpion Therapeutics
Scorpion Therapeutics is seeking an Associate Principal Scientist in Rahway, New Jersey, to drive CMC regulatory strategies for biologics. You will oversee authoring INDs, BLAs, and manage regulatory submissions, ensuring compliance with guidelines. The ideal candidate has over 10 years of relevant experience and a degree in a scientific field. Strong leadership, communication, and problem-solving skills are essential. This role offers opportunities for innovation and collaboration within a dynamic team. #J-18808-Ljbffr
- Associate Principal Scientist, Regulatory CMC - Biologics (R4) Responsibilities Implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies... .../approval status to support continued product supply. Lead authoring of clear, concise, effective IND/CTAs, BLAs,...Regulatory
$142.4k - $224.1k
...experienced Associate Principal Scientist to join our Cell Line... ...for late‑stage biologics programs with a focus on... ...and cell banking‑related regulatory strategy, filing... ...development, late‑stage CMC program support, regulatory... .... Key Responsibilities Lead and support cell line development...RegulatoryFor contractors- MSD Malaysia is looking for a leader in biologics sterile product development. The role focuses... ...studies to commercialization. You will lead innovative approaches and support both... ...focusing on formulation development and regulatory processes. Extensive benefits, including...Regulatory
$65k - $90k
...you to grow with us. We are seeking a Lead Wetland Scientist to join our team supporting projects... ...Environmental Science, Natural Resources, Biology, or a related field 5+ years of... ...preferred Experience with permitting or regulatory coordination is a plus Experience supporting...RegulatoryTemporary workWork at officeNight shift- Merck & Co. is seeking an Associate Principal Scientist in Regulatory Affairs, based in Rahway, NJ. The role involves developing and implementing CMC regulatory strategies for our pharmaceutical pipeline, focusing on respiratory and inhalation product development. The ideal...Regulatory
- ...MSD Malaysia is seeking an Associate Principal Scientist for Biologics Process Research & Development in Rahway, New Jersey, to lead downstream process development for biologics. The successful candidate will cooperate closely with cross-functional teams and be responsible...
- MSD Malaysia is looking for a skilled professional in Biologics Process Research & Development. This role involves leading upstream process development for biologics and ensuring compliance with regulatory standards. The ideal candidate holds a Ph.D. or Master's with extensive...Regulatory
$170k
...fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness... ...Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and...RegulatoryTemporary workMonday to FridayFlexible hours- Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC Company: Merck & Co. Location: Rahway, NJ. Job Description: Global Regulatory Affairs & Clinical Safety (GRACS) CMC - Associate Principal Scientist, CMC - Pharm Pre-approval (Respiratory/Inhalation...Regulatory
- ...is seeking an Associate Principal Scientist in Rahway, New Jersey to develop drug... ...manufacturing processes for the biologics pipeline. You will lead upstream process development and collaborate... ..., contributing to innovation and regulatory submissions. Extensive benefits and...Regulatory
$173.2k - $272.6k
...Job Overview Principal Scientist – Upstream Development Department... ...development. Responsibilities Lead biologic upstream process development... ..., commercialization, and regulatory filing activities to ensure... ...vendors. Knowledge of biologics CMC development cycle....RegulatoryFor contractors$173.2k - $272.6k
...Description for a Principal Scientist in BPR&D within our... ...addition to pipeline biologics process development, we... ...environment. Participate in or lead development of robust... ...characterization and regulatory filings for... ...Knowledge of biologics CMC development. Adaptability...RegulatoryFor contractors$173.2k - $272.6k
...Job Overview The Biologics Process Research & Development organization within... ...and experienced Principal Scientist to lead cross‑functional teams, develop CMC packages for pipeline assets, and... ...characterization, commercialization, and regulatory filing activities to ensure a...RegulatoryFor contractors- MSD Malaysia is seeking a Principal Scientist for the Upstream Development Department in Rahway, NJ, to drive process development for early- and late-stage clinical assets. The role requires a Ph.D. and significant industry experience in upstream development, excellence...
$173.2k - $272.6k
...New Jersey - Rahway The Biologics Process Research &... ...Department as a Principal Scientist. In this role, the... ...mentoring junior scientists, leading projects, and strong... ...will contribute to CMC development of our Company... ..., and regulatory filing activities to ensure...RegulatoryFor contractorsRelocationVisa sponsorshipFlexible hoursShift work- ...Lead Medical Laboratory Scientist Under supervision of a CLIA General Supervisor, the Lead Medical Laboratory... ...quality control, ensuring regulatory compliance, and consulting with various... ...science, chemical, physical or biological science, OR Master's degree in medical...RegulatoryFull timeTemporary workPart timeShift work
- ...Chemist (Contractor) in the Town of Newark, WI, to assist in leading technical efforts for pharmaceutical R&D. This role... ...validating analytical methods using HPLC and UPLC, supporting CMC testing, and preparing regulatory submissions. The ideal candidate will have a strong...RegulatoryContract workFor contractors
- ...Overview The Biologics Process Research & Development organization... ...Responsibilities Participates in and/or leads upstream process development... ...characterization, and regulatory filing activities to ensure a... .... Knowledge of biologics CMC development cycle and scale‑up...RegulatoryFor contractors
$142.4k - $224.1k
...Overview Associate Principal Scientist in the Biologics Process Development... ...manufacturing sites. Responsibilities Lead upstream process... ...development, characterization, and regulatory filing activities to... ...characterization. Knowledge of biologics CMC development cycle and scale...Regulatory$142.4k - $224.1k
...Description As a Assoc Principal scientist, you will drive the... ...Engineering & Synthetic Biology: Design and optimize... .... NGS Characterization: Lead NGS workflows, from library... ...to deliver integrated CMC solutions. Author technical reports for regulatory filings (IND/BLA)....RegulatoryFor contractors- ...Bristol-Myers Squibb is seeking a Manager for CMC Documentation in New Brunswick, NJ. The role involves compiling and authoring CMC sections of regulatory submissions, coordinating with various teams to ensure timely document delivery. Ideal candidates will have a degree...RegulatoryFlexible hours
- MSD Malaysia is seeking a Senior Scientist to lead analytical external capabilities within the PADT department. The role includes managing externalized analytical deliverables and driving scientific excellence in small molecule drug development. The ideal candidate will...
$142.4k - $224.1k
...Job Description The Biologics Analytical Research & Development... ...for an Associate Principal Scientist position available at its Rahway... ...and publish.- Experience leading small groups of technical personnel... ...reports, sections of regulatory filings (e.g., IND, BLA) and...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...exceptional individual for a Senior Scientist position within the Supply... .... Understand the global regulatory and business environment related... ...Working knowledge of CMC filing requirements and regulatory... ...Chromatography, Spectroscopy, Synthetic Biology Preferred Skills: Current...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$210.4k - $331.1k
...Job Overview Senior Principal Scientist (Sr. Director equivalent) – Immunology Biomarker Lead within Translational Clinical Biomarkers... ...decisions. Translate disease biology and therapeutic mechanism of... ..., discovery, translational, regulatory, bio‑stats, data science) to integrate...RegulatoryFor contractors$210.4k - $331.1k
...highly motivated Senior Principal Scientist (Sr. Director equivalent) to... ...as an Immunology Biomarker Lead within Translational Clinical... ...drug mechanism, disease biology, precision medicine, pharmacodynamics... ..., discovery, translational, regulatory, bio‑stats, and data sciences...RegulatoryFor contractors$142.4k - $224.1k
...Description Associate Principal Scientist, Data Engineer, Digital... ...processes across biologics and vaccines. The ideal candidate... ...Experience with sterile CMC development workflows, particularly... ...Databricks. Knowledge of regulatory expectations relevant to sterile...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut,... ...procedures supporting overall compliance including; contract, state/regulatory requirements Leverage technology expertise to engage across...RegulatoryOngoing contractContract workCasual workRemote workFlexible hours
$142.4k - $224.1k
Merck & Co. is looking for an Associate Principal Scientist in Rahway, NJ to lead downstream process development for biologics. The role requires a Ph.D. in Chemical Engineering or related field and offers a salary range of $142,400 to $224,100. The successful candidate...$142.4k - $224.1k
Merck in Rahway, NJ is looking for an Associate Principal Scientist to lead biologics sterile product development for a range of modalities.... ...innovative approaches for parenteral drug products, supporting regulatory filings and characterizing formulations. Merck offers a...Regulatory
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