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Associate Principal Scientist, Downstream Process Development

Merck
12 days ago
On-site
Rahway, NJ
Operations
Associate Principal Scientist – Downstream Process Development and Engineering

Job Responsibilities
- Contribute to CMC development by leading downstream process development and transfer to clinical and commercial manufacturing sites.
- Develop strategies for process and pipeline-facing innovation.

Responsibilities Include
- Lead biologic downstream process development for first-in-human and commercial processes by developing high-yield, robust, scalable processes; independently design and execute experiments using relevant operational parameters and analytical inputs.
- Provide technical supervision for process development and characterization.
- Collaborate with upstream process development, Biologics Analytical R&D, and cross-functional teams across Research and Manufacturing.
- Advance downstream platform process technical strategy; champion process improvement initiatives.
- Assess new technologies/sciences/industry strategies and relevance.
- Collaborate with academia, industry partners, and vendors to drive adoption of new process technologies.
- Stay current on external patent/literature landscape; present/publish externally and pursue patenting strategies.
- Mentor junior scientists.

Education Requirements
- Ph.D. with 3+ years industry experience OR Master with 6+ years OR BS with 8+ years in Chemical Engineering, Biochemical Engineering, or related field.

Required Skills
- Downstream process/technology development record with publication/presentation track record.
- Engineering understanding of recombinant protein purification unit operations; independently design/execute purification experiments.
- Direct planning, execution, analysis, and documentation for downstream development stages.
- Matrixed team collaboration with internal/external partners and vendors.
- Knowledge of biologics CMC development cycle.
- Initiative, creativity, and innovative problem solving.

Preferred Skills
- High-throughput experimentation with automation platforms (e.g., TECAN).
- Experience using/programming process control systems (e.g., DeltaV, PCS 7).
- Integrated/continuous processing and multi-column chromatography systems (e.g., BioSMB, PCC).
- Data science approaches for downstream processes/predictive modeling (multivariate analysis, ML/AI, PAT).

Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees); apply no later than the day before the posting end date (listed as 06/20/2026).