Associate Principal Scientist, Upstream Development
Merck
5 hours ago
On-site
Rahway, NJ
Operations
Associate Principal Scientist — Biologics Upstream Process Development
Responsibilities:
- Participate in and/or lead upstream process development of first-in-human and commercial processes by developing high-yield, robust, scalable cell culture processes.
- Lead process development, process characterization, and regulatory filing activities to support successful PPQs and BLAs.
- Partner cross-functionally (Discovery, Cell Line, Downstream Process Development, Analytical Sciences, Manufacturing) to deliver integrated clinical/commercial process solutions achieving Quality by Design targets with robust control strategies.
- Advance upstream platform processes through process improvement to increase operational efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
- Monitor external patent/literature environment; actively present/publish and pursue patenting strategies.
Qualifications:
- Ph.D. with 4+ years’ experience OR Master’s with 8+ years’ OR Bachelor’s with 12 years in chemical engineering, bioengineering, biological engineering, or related field.
Required Skills/Experience:
- Hands-on mammalian cell culture and fed-batch experience producing recombinant proteins.
- Working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale production.
- Knowledge of statistical methods (DoE, multivariate analysis) and tools (e.g., SIMCA, JMP).
- Understanding of bioreactors (microbioreactors, bench/pilot-scale) and scale-up principles.
- Proven upstream process/technology development with strong publication/presentation record.
- Ability to plan, execute, analyze, document all stages of cell culture process development; communicate complex data.
- Excellent written/verbal/interpersonal communication; cross-functional collaboration.
- Initiative, creativity, and innovation; laboratory productivity; deliver objectives under aggressive timelines.
Preferred Skills/Experience:
- Cell culture media development; high-throughput microbioreactors and in situ analytics; intensified inoculum/fed-batch and perfusion process development.
- Data science/predictive modeling (MFA/omics/ML), CFD, and PAT integration.
- Late-stage commercial process development, tech transfer, scale-down model qualification, process characterization.
- Biologics CMC development cycle; scale-up/down and tech transfer to GMP manufacturing.
Application:
- Apply via https://jobs.merck.com/us/en. Deadline is stated on the posting.
Responsibilities:
- Participate in and/or lead upstream process development of first-in-human and commercial processes by developing high-yield, robust, scalable cell culture processes.
- Lead process development, process characterization, and regulatory filing activities to support successful PPQs and BLAs.
- Partner cross-functionally (Discovery, Cell Line, Downstream Process Development, Analytical Sciences, Manufacturing) to deliver integrated clinical/commercial process solutions achieving Quality by Design targets with robust control strategies.
- Advance upstream platform processes through process improvement to increase operational efficiency and reduce costs.
- Collaborate with academia, industry partners, and vendors to drive development and adoption of new process technologies.
- Monitor external patent/literature environment; actively present/publish and pursue patenting strategies.
Qualifications:
- Ph.D. with 4+ years’ experience OR Master’s with 8+ years’ OR Bachelor’s with 12 years in chemical engineering, bioengineering, biological engineering, or related field.
Required Skills/Experience:
- Hands-on mammalian cell culture and fed-batch experience producing recombinant proteins.
- Working knowledge of CHO cell biology, metabolism, cell culture media, and engineering principles for large-scale production.
- Knowledge of statistical methods (DoE, multivariate analysis) and tools (e.g., SIMCA, JMP).
- Understanding of bioreactors (microbioreactors, bench/pilot-scale) and scale-up principles.
- Proven upstream process/technology development with strong publication/presentation record.
- Ability to plan, execute, analyze, document all stages of cell culture process development; communicate complex data.
- Excellent written/verbal/interpersonal communication; cross-functional collaboration.
- Initiative, creativity, and innovation; laboratory productivity; deliver objectives under aggressive timelines.
Preferred Skills/Experience:
- Cell culture media development; high-throughput microbioreactors and in situ analytics; intensified inoculum/fed-batch and perfusion process development.
- Data science/predictive modeling (MFA/omics/ML), CFD, and PAT integration.
- Late-stage commercial process development, tech transfer, scale-down model qualification, process characterization.
- Biologics CMC development cycle; scale-up/down and tech transfer to GMP manufacturing.
Application:
- Apply via https://jobs.merck.com/us/en. Deadline is stated on the posting.