Lead Biologics Upstream Process Development Scientist

Merck; Rahway (NJ); On-site; USD 150,000 - 210,000; Full time

Job summary

Merck in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams in developing CMC packages for biologics. You will direct upstream process development, scale-up, and tech transfer for cell culture assets advancing from early development to clinic and commercial supply.

The role requires a Ph.D. with 6+ years in industry, strong leadership, and a track record of publications and collaborations, plus experience with CHO fed-batch work, DOE, and CFD.

Qualifications

• Ph.D. with 6+ years of industry experience in Chemical Engineering, Bioengineering, Biochemistry or a related field.
• Proven record of upstream process development with publications and presentations.
• Experience in CHO fed-batch cell culture and understanding of downstream analytics.
• Hands-on experience with bioreactors at bench-to-pilot scale and tech transfer activities.
• Knowledge of DOE statistics and computational fluid dynamics.
• Ability to lead planning, execution, analysis and documentation of cell culture process development.
• Ability to work in a matrixed team and collaborate with vendors and partners.

Responsibilities

• Leading biologic upstream process development for first-in-human and commercial processes.
• Providing technical direction for process development, characterization, commercialization, and regulatory filings.
• Advancing upstream platform process strategy and championing continuous improvement initiatives.
• Initiating collaborations to assess new technologies and industry strategies.
• Collaborating with academia, industry partners, and vendors to drive development and innovation.
• Mentoring and educating junior scientists.

Skills

Upstream process development

Cell culture

Cross-functional leadership

DOE statistics

Process scale-up

Tech transfer

Education

Ph.D. in Chemical/Bioengineering/Biochemistry

Job description

Merck in Rahway, NJ seeks a Principal Scientist to lead cross-functional teams in developing CMC packages for biologics. You will direct upstream process development, scale-up, and tech transfer for cell culture assets advancing from early development to clinic and commercial supply.

The role requires a Ph.D. with 6+ years in industry, strong leadership, and a track record of publications and collaborations, plus experience with CHO fed-batch work, DOE, and CFD.