Associate Principal Scientist, Engineering - Vaccine, Sterile Drug Product Commercialization

Merck · West Point, PA

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

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Role summary

Merck seeks an Associate Principal Scientist to lead sterile drug product commercialization for vaccines and biologics. The role involves process characterization, scale-up, technology transfer, and regulatory strategy across late-stage and commercial pipeline programs.

What they're looking for

Experience with vaccine drug product process development and characterization across multiple modalities (conjugates, LVV, VLP, subunit, adjuvants)
Working understanding of analytical methods for vaccine characterization and cGMP sterile manufacturing practices
Experience with technology transfer, scale-up, and fill-finish operations at pilot and commercial scales
Strong oral and written communication skills to articulate process science in multidisciplinary team settings
Understanding of regulatory requirements for sterile drug product registration and Quality by Design principles
Technical expertise in sterile drug product fill-finish manufacturing processes and unit operations modeling

What you'll be doing

Lead cross-functional vaccine drug product teams supporting early and late pipeline programs through filing and PPQ
Develop and execute process characterization, technology transfer controls, and process validation activities
Design scale-down models and validate platform engineering approaches for sterile product commercialization
Author and review CMC regulatory submissions and influence commercialization strategy with manufacturing partners
Mentor technical staff and provide strategic guidance on complex scientific and process issues

Key requirements

Therapeutic area: Infectious Disease

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