ASSOCIATE PRINCIPAL SCIENTIST REGULATORY CMC - BIOLOGICS (R4)-SYNTHETIC MOIETIES (DRUG-LINKER) OF ADCs AND BIOCONJUGATES

Merck · North Wales (upper Gwynedd), PA +1 more

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RegulatoryFull-time$142k–$224kCompany career page

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Role summary

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 collaboration throughout product development and post-approval lifecycle.

What they're looking for

Bachelor's degree in chemistry, chemical engineering, biochemistry, or related science field; advanced degree preferred
At least 10 years pharmaceutical CMC or development experience (5 years with advanced degree)
Experience in process chemistry, analytical development, manufacturing, quality, or CMC product development
Demonstrated ability to critically review scientific data and assess technical arguments for clarity and support
Superior oral and written communication skills with ability to explain complex regulatory issues concisely
Strong project management, leadership, and stakeholder negotiation capabilities
Experience with ADCs, drug-linkers, payloads, peptides, or bioconjugate products preferred

What you'll be doing

Lead regulatory CMC strategy for synthetic moieties in assigned ADC and bioconjugate programs
Develop phase-appropriate global regulatory strategies addressing drug-linkers, payloads, and chemically synthesized components
Prepare and execute CMC documentation for IND, BLA, MAA, and post-approval submissions including agency responses
Integrate regulatory strategies across targeting components, conjugation processes, and final drug products
Manage change controls and collaborate with cross-functional teams to ensure compliance and scientific excellence

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