Biologics Process Development Scientific Lead
Merck
June 29, 2026
Remote friendly (Rahway, NJ)
United States
Operations
Biologics Process Development Scientific Lead provides technical leadership across biologics process development programs, driving functional alignment, leveraging technology platforms, and ensuring knowledge is shared across projects.
Key Responsibilities:
- Provide scientific/technical leadership across upstream and/or downstream unit operations.
- Champion platform-based development strategies.
- Drive knowledge sharing and functional alignment across projects.
- Facilitate knowledge capture and incorporate lessons learned.
- Partner with cross-functional stakeholders to align technical strategy and development plans.
- Design, execute, and/or oversee process development studies.
- Support process optimization, characterization, and scale-up/scale-down model development.
- Troubleshoot process challenges; perform root-cause evaluation and recommend data-driven solutions.
- Interpret process/analytical/manufacturing data and communicate recommendations.
- Review/approve technical reports, protocols, summaries, and documentation for regulatory filings and manufacturing readiness.
- Support scientific rigor, collaboration, and continuous improvement.
Education:
- PhD, MS, or BS in Biochemical Engineering, Chemical Engineering, Biology, Biotechnology, or related field.
- 15+ years (PhD), or 20+ years (MS/BS) relevant experience.
Required Experience/Skills:
- Strong biologics process development experience (upstream and/or downstream focus).
- Success in process development/optimization, scale-up, technology transfer, and platform process development.
- Ability to lead across functions and influence without authority.
- Excellent communication, collaboration, and coordination.
Preferred Experience/Skills:
- Platform process strategy across multiple programs.
- DoE, statistical analysis, process characterization, scale-up/scale-down modeling.
- Regulatory submissions and cGMP manufacturing experience.
- Integrated drug substance development/process lifecycle management exposure.
Benefits/Application:
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits include medical/dental/vision, retirement (401k), paid holidays, vacation, and sick/compassionate days.
- Apply via https://jobs.merck.com/us/en (application deadline stated on the posting).
Key Responsibilities:
- Provide scientific/technical leadership across upstream and/or downstream unit operations.
- Champion platform-based development strategies.
- Drive knowledge sharing and functional alignment across projects.
- Facilitate knowledge capture and incorporate lessons learned.
- Partner with cross-functional stakeholders to align technical strategy and development plans.
- Design, execute, and/or oversee process development studies.
- Support process optimization, characterization, and scale-up/scale-down model development.
- Troubleshoot process challenges; perform root-cause evaluation and recommend data-driven solutions.
- Interpret process/analytical/manufacturing data and communicate recommendations.
- Review/approve technical reports, protocols, summaries, and documentation for regulatory filings and manufacturing readiness.
- Support scientific rigor, collaboration, and continuous improvement.
Education:
- PhD, MS, or BS in Biochemical Engineering, Chemical Engineering, Biology, Biotechnology, or related field.
- 15+ years (PhD), or 20+ years (MS/BS) relevant experience.
Required Experience/Skills:
- Strong biologics process development experience (upstream and/or downstream focus).
- Success in process development/optimization, scale-up, technology transfer, and platform process development.
- Ability to lead across functions and influence without authority.
- Excellent communication, collaboration, and coordination.
Preferred Experience/Skills:
- Platform process strategy across multiple programs.
- DoE, statistical analysis, process characterization, scale-up/scale-down modeling.
- Regulatory submissions and cGMP manufacturing experience.
- Integrated drug substance development/process lifecycle management exposure.
Benefits/Application:
- Eligible for annual bonus and long-term incentive (if applicable).
- Comprehensive benefits include medical/dental/vision, retirement (401k), paid holidays, vacation, and sick/compassionate days.
- Apply via https://jobs.merck.com/us/en (application deadline stated on the posting).