Biologics Process Development Scientific Lead
Merck
August 12, 2026
On-site
Rahway, NJ
Operations
Biologics Process Development Scientific Lead (Executive Director level)
Key Responsibilities
- Provide scientific/technical leadership across biologics process development (upstream and/or downstream).
- Champion platform-based development to improve consistency, efficiency, and reuse of prior knowledge.
- Drive knowledge sharing and functional alignment across projects.
- Capture and transfer lessons learned across programs.
- Partner with cross-functional stakeholders to define technical strategy and development plans.
- Design, execute, and/or oversee process development studies to improve productivity, quality, robustness, and scalability.
- Support process optimization, characterization, and scale-up/scale-down model development.
- Troubleshoot process challenges; evaluate root causes and recommend data-driven solutions.
- Interpret process/analytical/manufacturing data and communicate recommendations.
- Review/approve technical reports, protocols, development summaries, and documentation for regulatory filings and manufacturing readiness.
Education
- PhD, MS, or BS in Biochemical Engineering, Chemical Engineering, Biology, Biotechnology, or related field.
- Experience: 15+ years (PhD), or 20+ years (MS/BS).
Required Experience/Skills
- Biologics process development expertise (upstream cell culture/fermentation and/or downstream purification).
- Proven success in optimization, scale-up, technology transfer, and platform development.
- Cross-functional leadership; influence without authority; strong communication/collaboration.
Preferred
- Platform process leadership across programs; DoE/statistics; characterization; scale-up/scale-down modeling.
- Regulatory submission and cGMP manufacturing experience; integrated drug substance/process lifecycle exposure.
Benefits/Compensation (if applicable)
- Annual bonus and long-term incentive; medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on posting). Requisition ID: R405499.
Key Responsibilities
- Provide scientific/technical leadership across biologics process development (upstream and/or downstream).
- Champion platform-based development to improve consistency, efficiency, and reuse of prior knowledge.
- Drive knowledge sharing and functional alignment across projects.
- Capture and transfer lessons learned across programs.
- Partner with cross-functional stakeholders to define technical strategy and development plans.
- Design, execute, and/or oversee process development studies to improve productivity, quality, robustness, and scalability.
- Support process optimization, characterization, and scale-up/scale-down model development.
- Troubleshoot process challenges; evaluate root causes and recommend data-driven solutions.
- Interpret process/analytical/manufacturing data and communicate recommendations.
- Review/approve technical reports, protocols, development summaries, and documentation for regulatory filings and manufacturing readiness.
Education
- PhD, MS, or BS in Biochemical Engineering, Chemical Engineering, Biology, Biotechnology, or related field.
- Experience: 15+ years (PhD), or 20+ years (MS/BS).
Required Experience/Skills
- Biologics process development expertise (upstream cell culture/fermentation and/or downstream purification).
- Proven success in optimization, scale-up, technology transfer, and platform development.
- Cross-functional leadership; influence without authority; strong communication/collaboration.
Preferred
- Platform process leadership across programs; DoE/statistics; characterization; scale-up/scale-down modeling.
- Regulatory submission and cGMP manufacturing experience; integrated drug substance/process lifecycle exposure.
Benefits/Compensation (if applicable)
- Annual bonus and long-term incentive; medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.
Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline stated on posting). Requisition ID: R405499.