Regulatory CMC Biologics Scientist - Hybrid/Global Leader
Merck
Scorpion Therapeutics is seeking a Senior Scientist (R3) in Regulatory CMC Biologics to lead global regulatory strategies across development and post-approval for biologics products. You will develop and execute robust CMC regulatory plans, manage INDs, BLAs, and post-approval variations, and ensure compliance with global agency requirements, with a Hybrid work setup in the US and travel as needed. #J-18808-Ljbffr Merck
$117k - $184.2k
Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND... ...robust, phase-appropriate global Regulatory CMC strategies for... ...Product Dossiers, original Biologics License Applications,... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Description Associate Principal Scientist, Regulatory CMC, Synthetic Moieties of ADCs... ...conjugates (ADC) and other biologics conjugate product... ...robust, phase-appropriate global Regulatory CMC strategies for... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Associate Principal Scientist role focused on developing... ...Manufacturing and Control regulatory strategies for vaccine... ...include leading global regulatory submissions,... ...Liaise with global CMC, manufacturing, and contract... ...chemical engineering, biology, microbiology, virology...RegulatoryContract work$142.4k - $224.1k
...Love This Role: As a Biologics Cell Culture Commercialization Leader, you’ll be at the... ...worldwide. Global Impact Collaborate... ...characterization and regulatory filing activities... ...regulatory submissions. CMC RA: Experience... ...mentor a team of scientists specializing in biologics...RegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$156.9k - $247k
...seeking a Principal Scientist to join our Separations... ..., adjuvants, biologics and other molecular... ...roadmaps aligned with CMC needs. Talent development... ...operations, regulatory compliance, and continuous... ...26 Our company is a global health care leader with a diversified portfolio...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
Job Description Senior Scientist (R3) REGULATORY CMC BIOLOGICS Position Description Serve as a Regulatory Chemistry... ...Be accountable for the execution of global product regulatory strategy(ies) by... ...Flexible Work Arrangements: Hybrid Job Posting End Date: 10/14/2026 *...RegulatoryFor contractorsLocal areaFlexible hours$210.4k - $331.1k
...Distinguished Scientist, Microbiology is... ...small molecule, biologics and vaccine... ...industry forums and regulatory partners to... ...Development teams; CMC and Regulatory... ...site and global SOPs; overseeing... ...scientific experienced leader and must be... ...Work Arrangements Hybrid Shift 1st - Day...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...division, quantitative scientists, in partnership with... ...discovery, development, regulatory approval,... ...benefit of patients and global human health. This... ...listings) A project leader; completes tasks independently... ...Work Arrangements: Hybrid Shift: Not Indicated...RegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work- ...Associate Principal Scientist position leading Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for antibody-drug conjugates and bioconjugates. Responsible for executing global regulatory submissions, managing synthetic moieties compliance, and cross-functional...Regulatory
$142.4k - $224.1k
...Development division, quantitative scientists, in partnership with other... ...the discovery, development, regulatory approval, manufacturing, and... ...the benefit of patients and global human health. The Associate... ...Work Arrangements: Hybrid Shift: Not Indicated...RegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...of Position The Regulatory Affairs Headquarters... ...Principal Scientist supports products... ...work closely with a global liaison(s) to help... ...Manufacturing and Control (CMC) as well as other... ...degree in biological science, chemistry... ...Work Arrangements: Hybrid Shift: 1st - Day...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$282.2k
...Description The Sr. Principal Scientist, Global Director of Medical Affairs... ...engagement with scientific leaders, research and educational... ...affairs activities to resolve regulatory, reputational, ethical, and... ...Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
Job DescriptionSenior Scientist (R3) REGULATORY CMC BIOLOGICSPosition Description:Serve as a Regulatory... ...cross-functional teams for the assigned biological projects. Be accountable for the... ...Be accountable for the execution of global product regulatory strategy(ies) by robust...RegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hours$117k - $184.2k
...Senior Scientist leading device design control activities for combination product development at Merck. Oversees regulatory compliance, cross-functional collaboration, and design control implementation... ...the product lifecycle in a hybrid New Jersey role. Responsibilities...Regulatory$142.4k - $224.1k
Job DescriptionThe Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This role is a laboratory... ...and appropriate sections of regulatory filings (e.g., IND, BLA).Experience with...RegulatoryFull timeFor contractorsLocal area- ...for an Environmental Scientist to continue their career... ...for government and global private-sector clients... ...federal, state, and local regulatory agencies; project... ...will be completed in a Hybrid work environment (you'... ...Bachelor's degree in biology, ecology, environmental...RegulatoryWork at officeLocal area
- ...Senior Scientist Statistical Programming role in late-stage clinical development supporting drug and vaccine programs.... ...reporting deliverables, and leading programming teams across global clinical trials and regulatory submissions. Responsibilities Develop and...Regulatory
$173.2k - $272.6k
...motivated Principal Scientist to provide strategic... ...mechanism, disease biology, pharmacodynamics, patient... ...Sciences, Regulatory, Data Science, Clinical... ...Work Arrangements: Hybrid Shift: Not Indicated... ...date. Our company is a global health care leader with a diversified portfolio...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$173.2k - $272.6k
...molecules, peptides, and biologics from preclinical... ...is a Principal Scientist-level technical... ...serve as a scientific leader across... ...Clinical, Quality, Regulatory, Manufacturing, and... ...Contribute to CMC regulatory submissions... ...Experience supporting global regulatory filings...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...division, quantitative scientists, in partnership with... ...discovery, development, regulatory approval,... ...benefit of patients and global human health Responsibilities... ...An understanding of biology of disease and drug discovery... ...Work Arrangements: Hybrid Shift: Not...RegulatoryFull timeContract workFor contractorsWork experience placementLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$255.8k - $402.7k
...opportunity for a physician-scientist to join our group... ...as part of a global team. -Primary... ...As a key member/leader of an early development... ...and simulation, regulatory affairs, and... ...responses to study biological activity in humans... ...Arrangements: Hybrid Shift: Not Indicated...RegulatoryFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$190.8k - $300.3k
...Therapeutic Area Leader (TAL) is a senior... ...understanding of regulatory expectations for immunology... ...that support global clinical... ...Compound Leaders, and scientists across NDS and/or... ...development, and CMC. Demonstrate situational... ...Arrangements: Hybrid Shift: 1st -...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Merck's Biologics Analytical Research & Development department seeks an Associate Principal Scientist to develop and qualify analytical methods for complex therapeutic proteins... ...Author and review technical reports, regulatory filing sections, and scientific publications...Regulatory$173.2k - $272.6k
Job Description Our Regulatory Affairs team bring new medical... ...to the world. The Global Regulatory Liaison is... ...and marketed drugs/biologics. Programs may be complex... ...Flexible Work Arrangements: Hybrid Shift: Not Indicated... ...a global health care leader with a diversified...RegulatoryFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift work$142.4k - $224.1k
...Job Description The Biologics Analytical Research & Development department of our Research... ...applicants for an Associate Principal Scientist position available at its Rahway, New... ...technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Merck & Co., Rahway, NJ, seeks a Principal Scientist, Engineering to lead late-stage small... ...technology transfer to commercial sites, and regulatory filing support while mentoring staff.... ...-functional collaboration across our global network and strategic decision-making capabilities...Regulatory
$117k - $184.2k
...Senior Scientist role leading regulatory chemistry, manufacturing, and control strategy for synthetic components... ...Responsibilities Lead regulatory CMC strategy for synthetic moieties of... ...Develop and execute phase-appropriate global regulatory CMC strategies for drug...Regulatory$210.4k - $331.1k
...accomplished scientific leader to join the... ...Oncology is part of the Global Clinical... ...key development and regulatory decisions. This... ...lead a team of QP2 scientists and serve as a key... ...small molecules, biologics including new modalities... ...Arrangements: Hybrid Shift: Not...RegulatoryFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...enthusiastic individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations,... ..., Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically...RegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hoursAfternoon shift$117k - $184.2k
Job DescriptionJob DescriptionThe Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading... ...materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.Lead the...RegulatoryFull timeFor contractorsLocal areaFlexible hours
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