Principal Scientist, Upstream Development
Merck
5 hours ago
On-site
Rahway, NJ
Operations
Principal Scientist, Upstream Development
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 to support PPQs and BLAs.
- Advance upstream platform process technical strategy and champion process improvement.
- Initiate collaborations to assess new technologies/industry strategies.
- Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
- Monitor external patent/literature environment; present/publish externally and pursue patenting strategies.
- Supervise, coach, and educate junior scientists.
Qualifications:
- Ph.D. with 8+ years industry experience; Master with 10+ years; or Bachelor’s with 14+ years in Chemical Engineering, Bioengineering, Biochemistry, or related field.
- Proven accomplishments in upstream process/technology development with strong publication/presentation record.
- Experience with CHO fed-batch cell culture; understanding of downstream & analytics.
- Hands-on cell culture bioreactors (micro/bench/pilot) and scale-up/tech transfer.
- Working knowledge of media, CHO cell biology/metabolism, DOE statistics, and computational fluid dynamics.
- Ability to plan, execute, analyze, and document all stages of cell culture process development.
- Knowledge of biologics CMC development cycle.
Preferred:
- Intensified inoculum and perfusion process development.
- Early-/late-stage commercial process development and technology transfer/scale-down model qualification.
- High-throughput microbioreactor systems and advanced in situ analytics.
- Media development/solution chemistry.
- Data science/predictive modeling (MFA, omics, machine learning), PAT integration, and CFD.
- Experience leading cross-functional program teams.
Benefits (explicitly listed): medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Deadline is stated on the posting.
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 to support PPQs and BLAs.
- Advance upstream platform process technical strategy and champion process improvement.
- Initiate collaborations to assess new technologies/industry strategies.
- Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
- Monitor external patent/literature environment; present/publish externally and pursue patenting strategies.
- Supervise, coach, and educate junior scientists.
Qualifications:
- Ph.D. with 8+ years industry experience; Master with 10+ years; or Bachelor’s with 14+ years in Chemical Engineering, Bioengineering, Biochemistry, or related field.
- Proven accomplishments in upstream process/technology development with strong publication/presentation record.
- Experience with CHO fed-batch cell culture; understanding of downstream & analytics.
- Hands-on cell culture bioreactors (micro/bench/pilot) and scale-up/tech transfer.
- Working knowledge of media, CHO cell biology/metabolism, DOE statistics, and computational fluid dynamics.
- Ability to plan, execute, analyze, and document all stages of cell culture process development.
- Knowledge of biologics CMC development cycle.
Preferred:
- Intensified inoculum and perfusion process development.
- Early-/late-stage commercial process development and technology transfer/scale-down model qualification.
- High-throughput microbioreactor systems and advanced in situ analytics.
- Media development/solution chemistry.
- Data science/predictive modeling (MFA, omics, machine learning), PAT integration, and CFD.
- Experience leading cross-functional program teams.
Benefits (explicitly listed): medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate and sick days.
Application: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Deadline is stated on the posting.