Director/Principal Scientist, Biologics Drug Substance Commercialization (BDSC)
Merck
September 02, 2026
Remote friendly (West Point, PA)
United States
Operations
Join Our Team as a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC).
Key Responsibilities
- Lead upstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs.
- Provide technical leadership for lab and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification.
- Serve as upstream subject matter expert across core unit operations with knowledge of downstream/analytical/GMP interdependencies.
- Ensure process/product knowledge is developed, documented, and transferred to meet regulatory expectations.
- Support technology transfer to internal/external manufacturing sites (scale-up, process validation, readiness).
- Contribute to manufacturing investigations and lifecycle management.
- Author/review technical and regulatory documentation supporting regulatory submissions.
- Drive division-wide initiatives aligned with biologics manufacturing/commercialization; influence multi-year planning and platform evolution.
- Represent BDSC on cross-functional/cross-divisional teams; collaborate with internal stakeholders and external CDMOs.
- Lead, coach, and mentor upstream scientists; support resource planning, staffing, and hiring; develop talent pipeline.
Education
- BS/MS/PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or related field (16+ years BS / 12+ years MS / 8+ years PhD relevant industry experience).
Required Experience & Skills
- Deep expertise in cell culture process development and commercialization.
- Ability to independently design/direct/execute/analyze/document process development stages.
- Experience supporting biologics commercialization (late-stage development and/or commercial manufacturing).
- Strong prioritization in fast-paced environments; cross-functional leadership/collaboration; action-oriented problem solving; commitment to coaching; excellent written/verbal communication.
Preferred Experience & Skills
- People management; leadership on drug substance working groups/program teams.
- Hands-on technology transfer, scale-up, validation; multi-specific antibody experience.
- Late-stage characterization, viral clearance, PPQ, validation.
- Regulatory submission (e.g., BLA sections) and/or partner collaboration.
- Analytical characterization knowledge, cGMPs, U.S./EU expectations; lean/operational excellence experience.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).
Key Responsibilities
- Lead upstream and/or integrated drug substance teams supporting late-stage clinical and commercial programs.
- Provide technical leadership for lab and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification.
- Serve as upstream subject matter expert across core unit operations with knowledge of downstream/analytical/GMP interdependencies.
- Ensure process/product knowledge is developed, documented, and transferred to meet regulatory expectations.
- Support technology transfer to internal/external manufacturing sites (scale-up, process validation, readiness).
- Contribute to manufacturing investigations and lifecycle management.
- Author/review technical and regulatory documentation supporting regulatory submissions.
- Drive division-wide initiatives aligned with biologics manufacturing/commercialization; influence multi-year planning and platform evolution.
- Represent BDSC on cross-functional/cross-divisional teams; collaborate with internal stakeholders and external CDMOs.
- Lead, coach, and mentor upstream scientists; support resource planning, staffing, and hiring; develop talent pipeline.
Education
- BS/MS/PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or related field (16+ years BS / 12+ years MS / 8+ years PhD relevant industry experience).
Required Experience & Skills
- Deep expertise in cell culture process development and commercialization.
- Ability to independently design/direct/execute/analyze/document process development stages.
- Experience supporting biologics commercialization (late-stage development and/or commercial manufacturing).
- Strong prioritization in fast-paced environments; cross-functional leadership/collaboration; action-oriented problem solving; commitment to coaching; excellent written/verbal communication.
Preferred Experience & Skills
- People management; leadership on drug substance working groups/program teams.
- Hands-on technology transfer, scale-up, validation; multi-specific antibody experience.
- Late-stage characterization, viral clearance, PPQ, validation.
- Regulatory submission (e.g., BLA sections) and/or partner collaboration.
- Analytical characterization knowledge, cGMPs, U.S./EU expectations; lean/operational excellence experience.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on posting).