Principal Scientist, Biologics Development
Merck
August 25, 2026
On-site
Rahway, NJ
Clinical Research and Development
Principal Scientist/Director, Biologics Drug Substance Commercialization (BDSC)
Responsibilities
- Lead upstream and/or integrated drug substance teams for late-stage clinical and commercial biologics (clear line of sight to licensure/commercialization).
- Provide technical leadership for lab and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification.
- Serve as upstream subject matter expert; ensure process/product knowledge is developed, documented, and transferred to meet standards and regulatory expectations.
- Support technology transfer (scale-up, process validation, manufacturing readiness) and contribute to lifecycle management/investigations.
- Author/review technical and regulatory documentation supporting regulatory submissions.
- Drive initiatives, influence multi-year planning (capabilities, digital systems, platform evolution), represent BDSC cross-functionally, and collaborate with internal/external partners.
- Lead/coach/mentor upstream scientists; support resource planning, staffing, hiring, and talent pipeline.
Education
- BS/MS/PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or related discipline.
- 16+ years (BS), 12+ years (MS), or 8+ years (PhD) relevant industry experience.
Required Skills/Experience
- Deep expertise in cell culture process development and commercialization.
- Ability to design, direct, execute, analyze, and document all stages of process development.
- Experience in biologics commercialization (late-stage and/or commercial manufacturing).
- Strong cross-functional leadership/collaboration, problem-solving, communication.
Preferred
- People management; drug substance working group/program team leadership.
- Hands-on technology transfer/scale-up/validation; multi-specific antibody experience.
- Late-stage characterization, viral clearance, PPQ, validation; regulatory submission (e.g., BLA sections).
- Knowledge of analytical characterization, cGMPs, U.S./EU expectations; lean leadership/operational excellence.
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable).
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if an employee). Application deadline is listed on the posting.
Responsibilities
- Lead upstream and/or integrated drug substance teams for late-stage clinical and commercial biologics (clear line of sight to licensure/commercialization).
- Provide technical leadership for lab and manufacturing scale studies supporting process characterization, validation, investigations, and continued process verification.
- Serve as upstream subject matter expert; ensure process/product knowledge is developed, documented, and transferred to meet standards and regulatory expectations.
- Support technology transfer (scale-up, process validation, manufacturing readiness) and contribute to lifecycle management/investigations.
- Author/review technical and regulatory documentation supporting regulatory submissions.
- Drive initiatives, influence multi-year planning (capabilities, digital systems, platform evolution), represent BDSC cross-functionally, and collaborate with internal/external partners.
- Lead/coach/mentor upstream scientists; support resource planning, staffing, hiring, and talent pipeline.
Education
- BS/MS/PhD in Chemical Engineering, Biological Engineering, Biochemical Engineering, or related discipline.
- 16+ years (BS), 12+ years (MS), or 8+ years (PhD) relevant industry experience.
Required Skills/Experience
- Deep expertise in cell culture process development and commercialization.
- Ability to design, direct, execute, analyze, and document all stages of process development.
- Experience in biologics commercialization (late-stage and/or commercial manufacturing).
- Strong cross-functional leadership/collaboration, problem-solving, communication.
Preferred
- People management; drug substance working group/program team leadership.
- Hands-on technology transfer/scale-up/validation; multi-specific antibody experience.
- Late-stage characterization, viral clearance, PPQ, validation; regulatory submission (e.g., BLA sections).
- Knowledge of analytical characterization, cGMPs, U.S./EU expectations; lean leadership/operational excellence.
Benefits (if applicable)
- Annual bonus and long-term incentive (if applicable).
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if an employee). Application deadline is listed on the posting.