Senior Regulatory CMC Lead, ADC Drug-Linkers
HireLifeScience.com
Merck & Co., Inc. in Rahway, NJ is seeking a Senior Scientist to lead Regulatory CMC for synthetic moieties in ADC programs, coordinating cross-functional teams to deliver regulatory milestones throughout development and lifecycle. The role requires a BS in science and 5+ years in Regulatory CMC or related pharmaceutical development, with experience in drug-linkers and bio-conjugates, and a strong focus on compliance and global filing strategies. #J-18808-Ljbffr HireLifeScience.com
Vacancy posted 4 hours ago
Similar jobs that could be interesting for youBased on the Senior Regulatory CMC Lead, ADC Drug-Linkers in Rahway, NJ vacancy
- Scorpion Therapeutics seeks an Associate Principal Scientist/Associate Director for Regulatory CMC focusing on biologics conjugates, ADCs, and bio‑conjugates. You will lead global regulatory strategies, prepare regulatory dossiers, and manage lifecycle changes for INDs...Regulatory
- ...Associate Principal Scientist/Associate Director in Regulatory CMC focusing on biologics conjugates, primarily ADCs and bio-conjugates, with responsibilities... ...lifecycle management for synthetic moieties like drug-linkers. The position involves providing regulatory leadership...Regulatory
- Role Senior Scientist (R3) Regulatory CMC focusing on synthetic moieties of ADCs and bioconjugates, providing regulatory leadership across product development and lifecycle... ...global regulatory CMC strategies for drug-linkers, payloads, peptides, and chemically synthesized...SeniorRegulatory
$117k - $184.2k
Job DescriptionSENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATESPosition Description:Serve as a Regulatory... ...Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC)...SeniorRegulatoryFull timeFor contractorsLocal areaMerck Sharp & Dohme (MSD)
Rahway, NJ2 days ago$117k - $184.2k
...Senior Scientist role leading regulatory chemistry, manufacturing, and control strategy... ...of antibody-drug conjugates and bioconjugates... ...Lead regulatory CMC strategy for... ...moieties of assigned ADC and bioconjugate programs... ...Experience with drug-linkers, payloads, ADCs,...SeniorRegulatory- Scorpion Therapeutics in Rahway, NJ invites a Senior Scientist (R3) to lead Regulatory CMC activities for synthetic moieties of ADCs and bioconjugates, guiding product... ...You will develop global CMC strategies for drug-linkers, payloads, and peptides, manage regulatory...Regulatory
$142.4k - $224.1k
...Principal Scientist position leading Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for antibody-drug conjugates and... ...synthetic moieties in assigned ADC and bioconjugate programs... ...strategies addressing drug-linkers, payloads, and chemically synthesized...Regulatory$173.2k - $272.6k
...integrated stage-appropriate CMC development and... ...technical, operational & regulatory success or timelines. Analyzes... ...associated with drug development, commercialization... ...with proven ability to lead complex discussions,... ...governance bodies, senior leadership, team members...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ3 days ago$210.4k - $331.1k
...(QP2 Oncology) team as Senior Director, Group Leader.... ...strategies to advance drug development. This would... ...for key development and regulatory decisions.This role provides... ..., Group Leader will lead a team of QP2... ...new modalities such as ADCs and TCEsTeam Leadership...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ4 days ago- Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content. The position requires...SeniorRegulatory
$180k - $270k
...medical needs. Kalaris’ lead asset, TH103, was... ...endothelial growth factor (VEGF) drug, specifically... ...is seeking an Director/Senior Director, Drug Product... ...production. Support IND/BLA regulatory submissions and... ...analytical & formulation, CMC, and company meetings....SeniorRegulatoryNight shiftKalaris Therapeutics
Berkeley Heights, NJ2 days ago- Breckenridge Pharmaceutical is seeking a Regulatory Affairs Manager to support regulatory CMC strategies and submissions for... ...complex sterile injectables and drug-device combinations. You will... ...Director of Regulatory Affairs, you will lead regulatory activities for assigned...Regulatory
$190.8k - $300.3k
...DescriptionThe Nonclinical Drug Safety (NDS)... ...Area Leader (TAL) is a senior scientific leader responsible... ...deep understanding of regulatory expectations for immunology... ...development, and CMC.Demonstrate situational... ...collaborations, and proactively lead internal cross-...SeniorRegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ7 days ago- Merck in Rahway, NJ seeks an experienced Regulatory Affairs professional to develop and implement... ...products. The role focuses on CMC dossiers, global submissions, and coordination... ...regulatory conformance. The candidate will lead documentation, authoring, and reviews for...Regulatory
- Merck & Co., Inc. in Rahway, NJ is seeking a senior Clinical Trial Operations leader to drive strategy and execution of one or more clinical... ...internal and external stakeholders to ensure trial milestones, regulatory compliance (GCP/ICH), and quality data. Strong leadership and...SeniorRegulatory
- ...Jersey, seeking a Licensed Site Remediation Professional (LSRP) to lead complex remediation projects across soil, groundwater, sediment... .... You will guide projects through NJDEP processes and manage regulatory submittals. The ideal candidate has a NJ LSRP license, 10+...SeniorRegulatory
$117k - $184.2k
...seeking a highly skilled and collaborative Senior Specialist to join our Animal Health Global... ...team. In this role, you will contribute as a drug safety expert, participating in safety surveillance, risk assessment, and regulatory compliance for our animal health product...SeniorRegulatoryFull timeFor contractorsWork experience placementWork at officeLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ4 days ago$173.2k - $272.6k
...Director-level role leading the Development and Commercialization Team for... ...Merck. Responsible for end-to-end CMC strategy execution, process development, regulatory filings, and commercial... ...Demonstrated expertise across drug substance, drug product, device,...Regulatory$156.9k - $247k
...including small molecules, peptides, anti-body drug conjugates, adjuvants, biologics and... ...to capability roadmaps aligned with CMC needs.Talent development and MentorshipPartner... ...ensure reliable laboratory operations, regulatory compliance, and continuous capability advancement...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ2 days ago- ADC Therapeutics America Inc. is seeking a Senior Clinical Development Physician Contractor to oversee the ZYNLONTA program... ...will review patient data, lead benefit-risk assessments, and collaborate... ...ensure timely risk mitigation and regulatory readiness. #J-18808-Ljbffr ADC...SeniorRegulatoryRemote jobFor contractors
- Key Responsibilities: Lead sponsor-side QA oversight of CMOs across... ...commercial manufacturing — drug substance, drug product, and final... ...Support quality review of regulatory submissions (IND/IMPD, NDA) and... ...QA cross-functionally with CMC, Supply Chain, and Analytical...SeniorRegulatory
- M&T Bank in Iselin, NJ seeks a Senior Compliance and Operational Risk Manager for Corporate Trust & Custody Services. The... ...with business leaders to strengthen controls and ensure regulatory alignment. You will lead risk assessments, issue management, and governance...SeniorRegulatoryWork at office
- Elevance Health seeks a Government Relations Director Senior for New Jersey to lead strategies advocating enterprise and state-level legislative and regulatory positions in complex environments, with potential multi-state responsibilities and direct engagement with policymakers...SeniorRegulatory
- ...Hospital in Newark, NJ is seeking a Sr Plumber/Steamfitter to lead maintenance, repair, and installation of plumbing, heating, steam... ...others, responding to calls, and ensuring compliance with safety and regulatory standards. #J-18808-Ljbffr University HospitalSeniorRegulatory
- Weston Solutions, Inc. is seeking a Senior Remediation Project Manager to lead multimillion-dollar remedial projects for industrial and government clients... ...candidate will have extensive remediation experience, regulatory knowledge, and a PE/P.G./LSRP-type credential...SeniorRegulatoryFor subcontractor
- Sarepta Therapeutics seeks an Associate Director of Regulatory Labeling and Disclosures to lead global labeling activities and clinical trial disclosures. You will collaborate with cross-functional teams and Health Authorities to ensure compliant labeling and transparency...SeniorRegulatoryRemote job
$117k - $184.2k
...join our Rahway, NJ team as a Senior Scientist (R3) in Biologics... ...Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical... ...process testing of Biologics Drug Substance (DS) and Drug... ...skills with adeptness to lead by influencing others.Self-motivated...SeniorRegulatoryFull timeFor contractorsLocal areaVisa sponsorshipFlexible hoursAfternoon shiftMerck Sharp & Dohme (MSD)
Rahway, NJ5 days ago- Scorpion Therapeutics seeks a Lead for statistical safety evaluation within its Clinical... ...design innovative statistical methods, ensure regulatory compliance, and clearly communicate safety findings to stakeholders, including senior management. Hybrid US role with some...SeniorRegulatory
$210.4k - $331.1k
...Oncology (QP2‑IO) team as Senior Director, Advanced... ...experts in quantitative drug development and possess... ...the Senior Director will lead advanced... ...including with vendors and regulatory agencies.Primary ResponsibilitiesStrategic... ...-drug conjugates (ADCs), T cell engagers (TCEs...SeniorRegulatoryFull timeFor contractorsLocal areaRemote workFlexible hoursMerck Sharp & Dohme (MSD)
Rahway, NJ7 days ago- Revlon is seeking a Senior Development Chemist to lead hands-on antiperspirant/deodorant formulation within the R&D team in Kenilworth, NJ. You will... ..., guide scale-up, and partner with Marketing, Regulatory, Packaging, and Manufacturing to deliver safe, compliant...SeniorRegulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory CMC Lead, ADC Drug-Linkers. Be the first to apply!
Related searches
- senior performance engineer Rahway, NJ
- senior manager diversity & inclusion Rahway, NJ
- senior director diversity & inclusion Rahway, NJ
- senior scientific director Rahway, NJ
- senior cloud network engineer Rahway, NJ
- senior software engineer remote Rahway, NJ
- senior ux designer remote Rahway, NJ
- senior net developer remote Rahway, NJ
- senior sas developer Rahway, NJ
- senior application security Rahway, NJ