Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control

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

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

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Role summary

Associate Principal Scientist role focused on developing and executing Chemistry, Manufacturing and Control regulatory strategies for vaccine and pharmaceutical products. Responsibilities include leading global regulatory submissions, managing compliance documentation, and liaising with internal and external manufacturing partners across the product lifecycle.

What they're looking for

Bachelor's degree in science, engineering, pharmacy, chemical engineering, biology, microbiology, virology, molecular biology, or biochemistry
At least 5 years pharmaceutical industry experience or 3 years managing CMC regulatory submissions for small molecules, vaccines, or biologics
Proficiency in Veeva and electronic document management systems
Strong written and oral communication skills with ability to convey complex information clearly
Knowledge of Chemistry, Manufacturing and Control regulatory requirements, BLA, eCTD, and international compliance standards
Experience reviewing scientific data and assessing technical merit of regulatory submissions

What you'll be doing

Lead development and authoring of Chemistry, Manufacturing and Control submission components for regulatory filings and health authority responses
Identify global regulatory requirements and assess supporting documentation for acceptability and risk mitigation
Liaise with global CMC, manufacturing, and contract manufacturing organizations to support compliant execution of changes
Deliver regulatory milestones and manage product lifecycle documentation across multiple assigned products
Communicate regulatory risks to stakeholders and propose mitigation strategies

Key requirements

Therapeutic area: Infectious Disease

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