Principal Scientist, Upstream Process Development
Merck
August 25, 2026
On-site
Rahway, NJ
Operations
Job Responsibilities:
- Lead biologic upstream process development for first-in-human and commercial processes by developing high-yield, robust, scalable cell culture processes.
- Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to enable successful PPQs and BLAs.
- Advance upstream platform process technical strategy and champion process improvement initiatives.
- Initiate collaborations to assess new technologies and industry strategies.
- Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
- Stay current on external patent/literature environment; present/publish externally and pursue patenting strategies.
- Mentor and educate junior scientists.
Minimum Education Required:
- Ph.D. with 6+ years industry experience OR Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry, or related field.
Required Experience and Skills:
- Upstream process and technology development accomplishments with strong publication/presentation record.
- CHO fed-batch cell culture experience and understanding of downstream & analytics.
- Hands-on cell culture bioreactor experience (microbioreactors, bench/pilot-scale) plus scaleup/tech transfer.
- Knowledge of cell culture media, CHO biology/metabolism, DOE statistics, and computational fluid dynamics.
- Ability to direct planning, execution, analysis, and documentation of cell culture process development stages.
- Matrixed environment collaboration with internal/external partners and vendors.
- Knowledge of biologics CMC development cycle.
- Late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
- Initiative, creativity, and innovation in problem solving; ability to develop staff and build collaborative teams.
Preferred Experience and Skills:
- Intensified inoculum and perfusion process development; high-throughput microbioreactors and in situ analytics; media development/media chemistry.
- Data science/predictive modeling (MFA, omics, ML) and experience integrating PAT; CFD.
- Experience leading cross-functional program development teams.
Required Skills (examples): Adaptability; Cell Culture Process Development; Leadership/Mentoring; Regulatory Filings; Quality by Design; Technology Transfer; Strategic Thinking; Data Analysis; Innovative Thinking.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.
- Lead biologic upstream process development for first-in-human and commercial processes by developing high-yield, robust, scalable cell culture processes.
- Provide technical direction for process development, characterization, commercialization, and regulatory filing activities to enable successful PPQs and BLAs.
- Advance upstream platform process technical strategy and champion process improvement initiatives.
- Initiate collaborations to assess new technologies and industry strategies.
- Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
- Stay current on external patent/literature environment; present/publish externally and pursue patenting strategies.
- Mentor and educate junior scientists.
Minimum Education Required:
- Ph.D. with 6+ years industry experience OR Master with 8+ years industry experience in Chemical Engineering, Bioengineering, Biochemistry, or related field.
Required Experience and Skills:
- Upstream process and technology development accomplishments with strong publication/presentation record.
- CHO fed-batch cell culture experience and understanding of downstream & analytics.
- Hands-on cell culture bioreactor experience (microbioreactors, bench/pilot-scale) plus scaleup/tech transfer.
- Knowledge of cell culture media, CHO biology/metabolism, DOE statistics, and computational fluid dynamics.
- Ability to direct planning, execution, analysis, and documentation of cell culture process development stages.
- Matrixed environment collaboration with internal/external partners and vendors.
- Knowledge of biologics CMC development cycle.
- Late-stage commercial process development, technology transfer, scale-down model qualification, and process characterization.
- Initiative, creativity, and innovation in problem solving; ability to develop staff and build collaborative teams.
Preferred Experience and Skills:
- Intensified inoculum and perfusion process development; high-throughput microbioreactors and in situ analytics; media development/media chemistry.
- Data science/predictive modeling (MFA, omics, ML) and experience integrating PAT; CFD.
- Experience leading cross-functional program development teams.
Required Skills (examples): Adaptability; Cell Culture Process Development; Leadership/Mentoring; Regulatory Filings; Quality by Design; Technology Transfer; Strategic Thinking; Data Analysis; Innovative Thinking.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if current employee). Application deadline is stated on the posting.