Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates
Merck · North Wales (upper Gwynedd), PA +1 more
RegulatoryFull-time$117k–$184kCompany career page
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Role summary
Senior Scientist role leading regulatory chemistry, manufacturing, and control strategy for synthetic components of antibody-drug conjugates and bioconjugates. Responsible for delivering regulatory milestones across product development and post-approval lifecycle while managing cross-functional collaboration.
What they're looking for
- Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, or related science field
- Minimum 5 years regulatory CMC or pharmaceutical development experience in small molecules or synthesized modalities
- Experience in process chemistry, analytical development, manufacturing, quality, or technical operations
- Expertise in regulatory CMC, chemistry, and analytical methods
- Strong regulatory compliance, document coordination, and communication skills
- Preferred: CMC regulatory submission support and health authority interaction experience
- Preferred: Experience with drug-linkers, payloads, ADCs, peptides, or bioconjugate products
What you'll be doing
- Lead regulatory CMC strategy for synthetic moieties of assigned ADC and bioconjugate programs
- Develop and execute phase-appropriate global regulatory CMC strategies for drug components
- Manage CMC documentation for IND applications, BLAs, MAAs, and post-approval submissions
- Integrate synthetic-moiety regulatory strategy with targeting component and conjugation process
- Conduct regulatory risk assessments and manage change controls with compliance focus
Privacy & handoff
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