Associate Principal Scientist, Global Vaccines Chemistry, Manufacturing and Control

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.

Responsibilities

• 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

Requirements

• 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

Compensation: $142,400 - $224,100 base