Senior Upstream Bioprocess Scientist, CMC & Scale-Up

JRNLClub; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck & Co. in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams developing CMC packages for biologics. You will direct upstream process development, ensure robust cell culture platforms, and engage in regulatory filings for PPQs and BLAs.

Collaboration with academia and vendors is expected. The role emphasizes mentorship of junior scientists, data-driven problem solving, and innovation in processing strategies for both early and late-stage development with a strong

Qualifications

• Mentoring and educating junior scientists.
• Proven record of upstream process and technology development with a strong publication/presentation track record.
• Experience in CHO fed-batch cell culture and understanding of downstream & analytics.
• Hands-on experience with cell culture bioreactors including microbioreactors, bench-scale and pilot-scale systems.
• Knowledge of cell culture media, CHO biology and metabolism, DOE statistics and CFD.
• Ability to plan, execute, analyze, and document all stages of cell culture process development.
• Ability to work in a matrixed team with internal and external partners.
• Experience with biologics CMC development cycle and tech transfer.

Responsibilities

• Lead biologics upstream process development for first-in-human and commercial processes.
• Provide technical direction for process development, characterization, and regulatory filings.
• Advance upstream platform process 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 innovation.
• Mentor and educate junior scientists and build collaborative teams.

Skills

Mentoring junior scientists

Cross functional leadership

Data science

Computational Fluid Dynamics (CFD)

CHO fed-batch experience

Education

Ph.D. in Chemical Engineering / Bioprocessing

Master's degree in a related field

Tools

Cell culture bioreactors

Microbioreactors

Bench-scale bioreactors

Pilot-scale bioreactors

Job description

Merck & Co. in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams developing CMC packages for biologics. You will direct upstream process development, ensure robust cell culture platforms, and engage in regulatory filings for PPQs and BLAs.

Collaboration with academia and vendors is expected. The role emphasizes mentorship of junior scientists, data-driven problem solving, and innovation in processing strategies for both early and late-stage development with a strong