Senior Bioprocess Scientist: Fermentation & Enzyme Transfer

Merck & Co.; Rahway (NJ); In loco; USD 117.000 - 184.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in Rahway, NJ, is seeking a Senior Scientist, Engineering to develop and de-risk safe, robust manufacturing processes for late-stage small molecule projects.

You will leverage expertise in microbial fermentation, downstream processing, and technology transfer to support global manufacturing and regulatory filings. You will mentor staff, work in a highly collaborative environment, and ensure compliance with cGMPs, GDPs, and quality systems while advancing internal capabilities and

Competenze

• PhD in Chemical Engineering or related field required.
• 3 years of experience in chemical/pharmaceutical process development.
• Experience with microbial fermentation and downstream processing; scale-up knowledge.
• Ability to lead experimental programs addressing design, robustness, and productivity.
• Experience with process scale-up and technology transfer from lab to pilot/factory.
• Mentor staff and collaborate across a cross-functional team.
• Strong communication, organization, and writing skills.

Mansioni

• Develop safe, robust manufacturing processes via characterization, technology transfer, validation, and supply support for late-stage projects in the small molecule pipeline.
• Optimize enzyme manufacturing process control across scales with microbial fermentation and downstream processing.
• Mentor junior staff and enhance laboratory capabilities for fermentation and downstream processing.
• Support transfer of technologies to commercial manufacturing.
• Apply Quality Risk Management and DOE-based experimental design.
• Conduct hands-on lab and kilo-lab experiments.
• Ensure compliance with cGMPs and GDPs and participate in risk assessments and deviations.

Conoscenze

Biocatalysis

Fermentation

Bioprocess Engineering

cGMP Regulations

Quality by Design

Technology Transfer

Process Design

Process Development

Process Scale Up

Regulatory Submissions

GMP

Small Molecule Drug Development

Vaccine Development

Formazione

PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or a related field

Descrizione del lavoro

Merck & Co. in Rahway, NJ, is seeking a Senior Scientist, Engineering to develop and de-risk safe, robust manufacturing processes for late-stage small molecule projects.

You will leverage expertise in microbial fermentation, downstream processing, and technology transfer to support global manufacturing and regulatory filings. You will mentor staff, work in a highly collaborative environment, and ensure compliance with cGMPs, GDPs, and quality systems while advancing internal capabilities and