Lead Biologics Upstream Process Scientist

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

Benefits offered by this job

401(k) plan

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams in developing CMC packages for biologics assets.

You will drive upstream process development, provide technical direction for PD, characterization, and regulatory filings, and mentor junior scientists. The role emphasizes collaboration across Discovery, Pre-clinical and Early Development, and with the Manufacturing Division for commercialization, including data science and digital tool usage to solve

Qualifications

• Mentoring and educating junior scientists.
• Proven record of upstream process and technology development with publications.
• Experience in CHO fed-batch cell culture and tools for downstream analytics.
• Hands-on experience with cell culture bioreactors and scale-up/tech transfer.
• Knowledge of DOE statistics and CFD.
• Ability to plan, execute, and document cell culture process development.
• Ability to work in a matrixed, cross-functional team.
• Knowledge of biologics CMC development cycle.
• Experience with late-stage process development and tech transfer.

Responsibilities

• Lead biologic 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 drive process improvements.
• Initiate collaborations to assess new technologies and industry strategies.
• Collaborate with academia, industry, and vendors to drive development and adoption of new processes.
• Monitor external patents and literature; publish and pursue patents as appropriate.
• Mentor and educate junior scientists.

Skills

Mentoring

Upstream process development

CHO fed-batch

Bioreactors

DOE statistics

CFD

Project leadership

Cell culture strategy

Regulatory filings

Cross-functional collaboration

Education

Ph.D. with 6+ years or M.S. with 8+ years in Chemical Engineering/Bioengineering/Biochemistry

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams in developing CMC packages for biologics assets.

You will drive upstream process development, provide technical direction for PD, characterization, and regulatory filings, and mentor junior scientists. The role emphasizes collaboration across Discovery, Pre-clinical and Early Development, and with the Manufacturing Division for commercialization, including data science and digital tool usage to solve