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 Scorpion Therapeutics
- 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
**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...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$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$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
- MSD Malaysia is seeking an Associate Principal Scientist to lead design verification strategies for drug-device combination products. This... ...functional teams to ensure thorough testing strategies aligned with regulatory and quality objectives. The ideal candidate will have a...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
$142.4k - $224.1k
...experienced Associate Principal Scientist to join our Cell Line... ...for late-stage biologics programs with a focus... ...and cell banking-related regulatory strategy, filing... ...development, late-stage CMC program support, regulatory... ...Responsibilities Lead and support cell line development...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...characterization and regulatory filing activities to ensure... ...culture processing of biologics (large molecule... ...regulatory submissions.* CMC RA: Experience supporting... .... Mentor a team of scientists specializing in biologics... ....* Innovation: Lead business improvement initiatives...RegulatoryLocal area
$142.4k - $224.1k
...Division, specifically within the Biologics Drug Substance... ...passionate and skilled individual to lead the charge in transforming our... ...world. The Associate Principal Scientist (Associate Director) provides... ..., and in compliance with regulatory requirements. By partnering closely...RegulatoryFull timeContract workFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...Jersey - Rahway The Biologics Process Research & Development... ...as a Principal Scientist. In this role, the successful... ...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$142.4k - $224.1k
...Overview Associate Principal Scientist in the Biologics Process Development... ...sites. Responsibilities Lead upstream process development... ...development, characterization, and regulatory filing activities to... ...characterization. Knowledge of biologics CMC development cycle and scale...Regulatory- 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...
- ...Job Description The Biologics Analytical Research & Development... ...seeking applicants for a Principal Scientist position available at its... ...define analytical strategy and to lead a team of scientists in... ...technical reports, sections of regulatory filings (e.g., IND, BLA) and...RegulatoryFull timeFor contractorsWork at officeLocal areaRemote workRelocationVisa sponsorshipFlexible hoursShift work3 days per week
$173.2k - $272.6k
...the position of Principal Scientist with deep subject-matter expertise to lead the design and... ...administration, and supporting regulatory filings. Collaborate with... ...for inhalation products (CMC sections for NDAs/BLAs/... ...experience working with biologic/large-molecule inhalation...RegulatoryFull timeFor 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$142.4k - $224.1k
Merck & Co. is seeking an experienced leader in biologics sterile product development. The successful candidate will lead innovative drug product composition and ensure regulatory compliance. The role requires a Ph.D. in a relevant field, along with a significant background...Regulatory$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...Regulatory$173.2k - $272.6k
Merck & Co. is seeking a Director to lead the Pharmaceutical Analytical Sciences team in Rahway, NJ. This highly strategic role involves... ...for drug development and requires strong leadership and regulatory knowledge. The ideal candidate will have a PhD in Chemistry with...Regulatory$87.3k - $137.4k
Job Description Scientist, Process Cell Sciences (PCS) at Rahway, NJ The Biologics Process Research & Development organization... ...including proactive planning and leading TT meetings. Design and... ...manufacturing process. Familiar with regulatory guidelines related to...RegulatoryFor contractors$255.8k - $402.7k
...manage and oversee the entire cycle of clinical development, including study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. They will provide internal scientific leadership...RegulatoryFor contractorsWorldwide$154k - $182k
...Senior Manager, Regional Regulatory Lead-North America for Vaccines CSL Seqirus is a leading... ..., including GRAS Regions and Regulatory CMC. Proactively fosters and promotes effective... ...: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine...RegulatoryLocal area3 days per week$169.7k - $267.2k
Job Description The Principal Scientist, Drug Discovery in our... ...advance novel targets and will lead these research programs from... ...or biotechnology Knowledge of regulatory aspects of pharmaceuticals including... ...Project Teams, Molecular Biology Techniques, Persuasion, Professional...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$255.8k - $402.7k
## Distinguished Scientist (Executive Director), Asset Development Team LeaderApplyremote type: Hybridlocations: USA - New Jersey - Rahwaytime... ...study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hours$286.9k
...Senior Principal Scientist (Senior Medical Director) Translational... ...working closely with scientific, regulatory, statistical, and modeling... ...Immunology Therapeutic Area Lead in Translational Medicine.... ...imaging, responses to interrogate biological activity in humans. Provide...RegulatoryWorldwide- ...submission documents. Evaluate the impact of regulatory changes on existing registrations and... ...users on requirements, chemical & biological record registration processes.... ...performance and efficiency. Collaborate with scientists, business users, to understand their...Regulatory
$142.4k - $224.1k
...position of Associate Principal Scientist focused on developing... ...antibody‑drug conjugates, and biologics). The successful candidate must... ...environment. Primary Duties Lead/ contribute towards the new,... ...administration, and supporting regulatory filings. Build deep fundamental...RegulatoryFor contractorsLocal area$142.4k - $224.1k
...the direction of the Program Lead, you will collaborate with global... ...Serves as the lead clinical scientist on the clinical trial team.... ...on clinical/scientific and regulatory documents. Partners with Study... ...Analytical Problem Solving Biological Sciences Clinical Data Interpretation...RegulatoryFlexible hoursShift work
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