Regulatory CMC Lead, Drug-Linkers & Bioconjugates
HireLifeScience.com
Merck & Co., Inc. in the United States is seeking a Senior Scientist (R3) Regulatory CMC to lead the regulatory chemistry aspects of ADC drug-linkers and Bioconjugates. You will provide regulatory leadership within Regulatory and cross-functional teams to deliver milestones throughout development and lifecycle. The role requires 5+ years in regulatory CMC or related pharmaceutical development, with experience in drug-linkers, payloads, ADCs, and global submissions. #J-18808-Ljbffr
Vacancy posted 14 hours ago
Similar jobs that could be interesting for youBased on the Regulatory CMC Lead, Drug-Linkers & Bioconjugates in North Wales, PA vacancy
$117k - $184.2k
Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATES Position Description Serve as a Regulatory... ...Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$117k - $184.2k
...Senior Scientist role leading regulatory chemistry, manufacturing, and... ...components of antibody-drug conjugates and bioconjugates. Responsible for delivering... ...Lead regulatory CMC strategy for synthetic moieties... ...Preferred: Experience with drug-linkers, payloads, ADCs, peptides...Regulatory$173.2k - $272.6k
...integrated stage-appropriate CMC development and commercialization... ...technical, operational & regulatory success or timelines. Analyzes... ...typical uncertainty associated with drug development, commercialization... ...manner with proven ability to lead complex discussions, influence...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA5 days ago- ...., Inc. is seeking a Principal Scientist to lead biologics process development, scale-up, and... ...emphasizes process characterization, validation, and CMC strategies across global sites. The candidate will drive PPQ readiness, regulatory submissions, and continuous improvement in...Regulatory
- ...CSL Behring seeks a Team Lead, Global Regulatory Affairs to drive CMC regulatory strategy for biological and non-biological products. This role collaborates with Global Operations, R&D, and QA to ensure timely, compliant submissions and lifecycle management. Ideal candidates...Regulatory
BioSpace, Inc.
King of Prussia, PA4 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- CSL, headquartered in King of Prussia, seeks a Senior Manager Global Regulatory Affairs CMC to drive regulatory strategy for biological and non-biological products. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs to meet evolving CMC requirements...Regulatory
- CSL Behring in King of Prussia, PA seeks a Senior Manager Global Regulatory Affairs CMC—Biological & Non-Biol. Products to lead regulatory strategy and submissions for a dynamic product portfolio. You will partner with R&D, Manufacturing, Quality, and Regulatory Affairs...Regulatory
- ...Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide regulatory strategies across development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy...Regulatory
Johnson & Johnson Innovative Medicine
Horsham, PA4 days ago $76k - $121.9k
...cGMP Compliance and Investigations Lead to join our Innovative Medicine... ...and trends, supports regulatory gap assessments and change controls... ...Chemistry Manufacturing, and Control (CMC) Clinical Trial Protocols Collaboration Data Quality Drug Discovery Development Execution...RegulatoryWork at officeLocal areaJohnson & Johnson Innovative Medicine
Spring House, PA5 days ago- ...Scorpion Therapeutics seeks a Senior Director of Regulatory Affairs CMC to provide strategic and operational leadership for regulatory chemistry, manufacturing, and controls activities supporting clinical trials, market registrations, and post-approval submissions for...Regulatory
Madrigal Pharmaceuticals Inc
Conshohocken, PA3 days ago - ...Commercialization Team (DCT) responsible for delivering a stage-appropriate CMC development and commercialization strategy for the biologics... ...will drive risk-informed decisions, collaborate across DS/DP/Regulatory/Quality and Supply Chain, and ensure cGMP compliance while...Regulatory
- The Senior Manager Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for... ...and international standards governing drug product development, manufacture, registrations... ...delivery.Demonstrated ability to lead cross-functional teams and collaborate...RegulatoryFull timeLocal areaFlexible hours
CSL
Valley Forge, Montgomery County, PA5 days ago - ...Johnson & Johnson seeks a Senior Manager to lead global diagnostic strategies supporting oncology precision medicine drug development. This developmental leadership role... ...aligned with clinical development and regulatory plans Independently lead defined diagnostic...Regulatory
Johnson & Johnson
Spring House, PA10 days ago - MSD Malaysia is seeking a Distinguished Scientist to serve as a Drug Metabolism and Pharmacokinetics (DMPK) submission expert. This... ...marketing and through life-cycle management. The role influences regulatory filings, labeling discussions and approvals as part of the DMPK...Regulatory
- ...Merck seeks a Principal Scientist to lead sterile biologics drug product commercialization activities,... ..., scale-up, technology transfer, and regulatory submissions. The role requires deep expertise... ...activities Author and review CMC regulatory submissions; support...Regulatory
Merck
West Point, PA12 days ago $204k - $249k
...connected by our shared purpose: leading the fight against MASH.... ...in the right way.The Director, Drug Product SME is an experienced... ...responsibility for advancing the CMC development of Madrigal’s siRNA... ...inputs that support CMC authoring, regulatory traceability, and program...RegulatoryMinimum wageFull timeLocal areaFlexible hoursMadrigal Pharmaceuticals
Conshohocken, PA7 days ago$137k - $235.75k
...Senior Principal Scientist role leading regulatory strategy and compliance for combination products... ...guidance on global regulatory requirements, drug-device integration, and lifecycle... ...combination product regulatory affairs and CMC strategy Deep knowledge of global regulatory...Regulatory- ...HireLifeScience seeks an Associate Director, Regulatory Affairs – Power Platform Solutions Specialist to technically lead Power Apps, Dataverse, and Power Automate implementations supporting regulatory requirements. You will configure data models, automate workflows,...Regulatory
Merck & Co. Inc
North Wales, PA5 days ago - ...Corporation seeks a Senior Managing Consultant in air quality compliance & permitting to lead complex projects within Ramboll's Environment & Health division. You will guide regulatory interpretation, emissions estimation, and air permit preparation for diverse industries...Regulatory
Ramboll US Corporation
Blue Bell, PA2 days ago $142.4k - $224.1k
...Manufacturing Division, the Sterile Drug Product Commercialization... ...validation, authoring of regulatory submissions and support of significant... ...and Responsibilities:Leads and/or serves on cross functional... ...shelf-life strategies.Influences CMC regulatory strategy and is...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA6 days ago$173.2k - $272.6k
...Company’s Manufacturing Division, the Sterile Drug Product Commercialization group provides... ...sites, process validation, authoring of regulatory submissions and support of significant... ...PPQ) and shelf-life strategies.Influences CMC regulatory strategy and is accountable...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA6 days ago$190.8k - $300.3k
Job DescriptionThe Nonclinical Drug Safety (NDS) Therapeutic Area... ...immunology, a deep understanding of regulatory expectations for immunology... ..., clinical development, and CMC.Demonstrate situational... ...collaborations, and proactively lead internal cross-departmental initiatives...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
West Point, PA4 days ago- ...in Spring House, PA seeks a cGMP Compliance and Investigations Lead to drive deviation investigations and CAPA programs supporting... ...inspection-ready. The role requires leading complex investigations, regulatory awareness (FDA/EMA), and strong documentation practices, with a...Regulatory
Johnson & Johnson Innovative Medicine
Spring House, PA4 days ago - ...world leader in health care, seeks a cGMP Compliance and Investigations Lead for its Innovative Medicine team in Spring House, PA. You will guide investigations, CAPA development, and regulatory readiness across QA/QC and manufacturing functions. The role requires in-...Regulatory
Johnson & Johnson
Spring House, PA3 days ago $129k - $153k
...difference worldwide.Position Overview: Regulatory leaders who leverage regional regulatory... ...GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’,... ...regulatory deliverables (including leading assigned tasks) while fostering individual...RegulatoryFull timeWorldwideRelocation packageCSL
Valley Forge, Montgomery County, PA5 days ago- ...Johnson & Johnson is seeking a Submissions & Regulatory Intelligence Manager within IDAR to provide expert guidance on clinical data submission requirements and regulatory strategies across multiple countries. You will serve as the primary point of contact for data...Regulatory
6084-Janssen Research & Development, LLC Legal Entity
Spring House, PA3 days ago - Merck in Rahway, NJ seeks a Senior Principal Scientist, Regulatory Affairs Liaison to lead worldwide regulatory strategy for General Medicine programs focused on cardiovascular metabolic areas. You will ensure optimal labeling and the fastest time to approval by engaging...RegulatoryWorldwide
$210.4k - $331.1k
...of utilizing MIDD strategies to advance drug development. This would include translational... ...e.g. QSP, AI/ML) for key development and regulatory decisions.This role provides strategic... .... The Senior Director, Group Leader will lead a team of QP2 scientists and serve as a key...RegulatoryFull timeFor contractorsLocal areaFlexible hoursMerck Sharp & Dohme (MSD)
North Wales, PA6 days ago- Scorpion Therapeutics seeks an Executive Director of Regulatory Affairs Liaison in General Medicine to lead global regulatory strategy for ophthalmology... ...external representation. The role requires extensive drug development and regulatory leadership experience, including...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory CMC Lead, Drug-Linkers & Bioconjugates. Be the first to apply!
