Principal Scientist/Director (Downstream), Biologics Drug Substance Commercialization (BDSC)

Merck · West Point, PA +1 more

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CMCFull-time$173k–$273kCompany career page

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Role summary

Senior scientific and people leadership role supporting late-stage and commercial biologics programs within the Downstream Purification department. The Principal Scientist will lead teams on downstream processing strategy, technology transfer, and manufacturing scale-up while managing scientific staff and collaborating across cross-functional organizations.

What they're looking for

BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or related discipline
14+ years (BS), 12+ years (MS), or 6+ years (PhD) of biopharmaceutical industry experience
Deep technical expertise in biologics downstream processing and process development
Experience supporting biologics commercialization and late-stage or commercial manufacturing
Demonstrated leadership and collaboration skills in cross-functional, matrixed environments
Strong track record of process characterization, validation, and manufacturing problem-solving
Proven ability to coach, mentor, and develop scientific staff

What you'll be doing

Lead downstream and integrated drug substance teams for late-stage clinical and commercial programs
Provide technical expertise on unit operations and ensure process knowledge documentation aligns with regulatory standards
Support technology transfer, scale-up, and process validation activities to manufacturing sites
Author and review technical and regulatory documentation for submissions
Lead, mentor, and develop a team of downstream scientists while supporting resource planning and hiring

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