Associate Principal Scientist, Upstream Process Development
Merck
August 25, 2026
On-site
Rahway, NJ
Operations
Associate Principal Scientist – Upstream Process Development (CMC)
Responsibilities:
- Participate in and/or lead upstream process development for first-in-human and commercial processes by developing high-yield, robust, scalable cell culture processes.
- Conduct process development, process characterization, and regulatory filing activities to support PPQs and BLAs.
- Partner cross-functionally (Discovery, Cell Line, Downstream Process Development, Analytical Sciences, Manufacturing) to deliver integrated clinical and commercial process/manufacturing solutions with quality-by-design targets and robust control strategies.
- Advance upstream platform processes via process improvement to increase efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to develop and adopt new process technologies.
- Stay current with external literature; present/publish externally and pursue patenting strategies.
Minimum Education:
- Ph.D. with 4+ years’ experience, or Master’s with 8+ years’ experience in chemical engineering, bioengineering, biological engineering, or related field.
Required Qualifications/Skills:
- Hands-on mammalian cell culture and fed-batch experience producing recombinant proteins.
- Working knowledge of CHO cell biology, metabolism, media, and large-scale recombinant protein engineering principles.
- Statistical methods and tools (DoE, multivariate analysis; SIMCA, JMP, etc.).
- Bioreactor knowledge (micro/bench/pilot) and scale-up principles.
- Track record of upstream process/technology development with publications/presentations.
- Ability to plan, execute, analyze, and document all stages of cell culture process development; manage and communicate complex data.
- Strong verbal/written/interpersonal and cross-functional collaboration skills; initiative, creativity, and innovation.
Preferred Qualifications/Skills:
- Cell media development; high-throughput microbioreactors and in situ analytics.
- Intensified inoculum/fed-batch and perfusion development.
- Data science/predictive modeling (MFA, omics, ML), CFD, and PAT integration.
- Late-stage commercial process development, tech transfer, scale-down model qualification, process characterization; biologics CMC cycle and GMP site tech transfer.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
Responsibilities:
- Participate in and/or lead upstream process development for first-in-human and commercial processes by developing high-yield, robust, scalable cell culture processes.
- Conduct process development, process characterization, and regulatory filing activities to support PPQs and BLAs.
- Partner cross-functionally (Discovery, Cell Line, Downstream Process Development, Analytical Sciences, Manufacturing) to deliver integrated clinical and commercial process/manufacturing solutions with quality-by-design targets and robust control strategies.
- Advance upstream platform processes via process improvement to increase efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to develop and adopt new process technologies.
- Stay current with external literature; present/publish externally and pursue patenting strategies.
Minimum Education:
- Ph.D. with 4+ years’ experience, or Master’s with 8+ years’ experience in chemical engineering, bioengineering, biological engineering, or related field.
Required Qualifications/Skills:
- Hands-on mammalian cell culture and fed-batch experience producing recombinant proteins.
- Working knowledge of CHO cell biology, metabolism, media, and large-scale recombinant protein engineering principles.
- Statistical methods and tools (DoE, multivariate analysis; SIMCA, JMP, etc.).
- Bioreactor knowledge (micro/bench/pilot) and scale-up principles.
- Track record of upstream process/technology development with publications/presentations.
- Ability to plan, execute, analyze, and document all stages of cell culture process development; manage and communicate complex data.
- Strong verbal/written/interpersonal and cross-functional collaboration skills; initiative, creativity, and innovation.
Preferred Qualifications/Skills:
- Cell media development; high-throughput microbioreactors and in situ analytics.
- Intensified inoculum/fed-batch and perfusion development.
- Data science/predictive modeling (MFA, omics, ML), CFD, and PAT integration.
- Late-stage commercial process development, tech transfer, scale-down model qualification, process characterization; biologics CMC cycle and GMP site tech transfer.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).