Associate Principal Scientist, Upstream Process Development
Merck
12 days ago
On-site
Rahway, NJ
Operations
Associate Principal Scientist – Upstream Process Development
Responsibilities:
- Participate in and/or lead upstream process development for first-in-human and commercial cell culture processes (high yield, robust, scalable).
- Lead process development, characterization, and regulatory filing activities to support PPQs and BLAs.
- Partner cross-functionally (Discovery, Cell Line, Downstream/Analytical Sciences, Manufacturing) to deliver integrated clinical/commercial manufacturing solutions with QbD targets and robust control strategies.
- Improve upstream platform processes to increase efficiency and reduce costs.
- Collaborate with academia/industry/vendors to drive new process technologies.
- Stay current with external literature; present/publish and pursue patent strategies.
Minimum Education:
- Ph.D. with 4+ years’ experience OR Master’s with 8+ years’ experience in chemical engineering, bioengineering/biological engineering, or related field.
Required Skills/Experience:
- Hands-on mammalian cell culture and fed-batch experience producing recombinant proteins.
- CHO cell biology/metabolism/media and large-scale recombinant protein system knowledge.
- Statistical methods (DoE, multivariate analysis) and tools (e.g., SIMCA, JMP).
- Bioreactor knowledge (micro/pilot scale) and scale-up principles.
- Track record in upstream process/technology development with publication/presentation.
- Ability to plan/execute/analyze/document cell culture process development and communicate complex data.
- Strong verbal/written/interpersonal skills; cross-functional collaboration in matrix environments; initiative/innovation; lab productivity; meet aggressive timelines.
Preferred:
- Media development; high-throughput microbioreactors and in situ analytics.
- Intensified inoculum/fed-batch and perfusion development.
- Data science/predictive modeling (MFA, omics, ML) and PAT integration.
- Late-stage commercial development/tech transfer/scale-down model qualification.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if internal).
Responsibilities:
- Participate in and/or lead upstream process development for first-in-human and commercial cell culture processes (high yield, robust, scalable).
- Lead process development, characterization, and regulatory filing activities to support PPQs and BLAs.
- Partner cross-functionally (Discovery, Cell Line, Downstream/Analytical Sciences, Manufacturing) to deliver integrated clinical/commercial manufacturing solutions with QbD targets and robust control strategies.
- Improve upstream platform processes to increase efficiency and reduce costs.
- Collaborate with academia/industry/vendors to drive new process technologies.
- Stay current with external literature; present/publish and pursue patent strategies.
Minimum Education:
- Ph.D. with 4+ years’ experience OR Master’s with 8+ years’ experience in chemical engineering, bioengineering/biological engineering, or related field.
Required Skills/Experience:
- Hands-on mammalian cell culture and fed-batch experience producing recombinant proteins.
- CHO cell biology/metabolism/media and large-scale recombinant protein system knowledge.
- Statistical methods (DoE, multivariate analysis) and tools (e.g., SIMCA, JMP).
- Bioreactor knowledge (micro/pilot scale) and scale-up principles.
- Track record in upstream process/technology development with publication/presentation.
- Ability to plan/execute/analyze/document cell culture process development and communicate complex data.
- Strong verbal/written/interpersonal skills; cross-functional collaboration in matrix environments; initiative/innovation; lab productivity; meet aggressive timelines.
Preferred:
- Media development; high-throughput microbioreactors and in situ analytics.
- Intensified inoculum/fed-batch and perfusion development.
- Data science/predictive modeling (MFA, omics, ML) and PAT integration.
- Late-stage commercial development/tech transfer/scale-down model qualification.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if internal).