Principal Scientist, Biologics Sterile Product Development

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking an experienced leader in biologics sterile product development to drive late-stage formulation and process development for non-oral dosage forms, including injectables and implants.

You will collaborate across functions to design robust drug product strategies and ensure scalable manufacturing. The role emphasizes technical leadership, strategic planning, and documentation for regulatory filings, with opportunities to mentor scientists and contribute to

Qualifications

• Ph.D. or equivalent with relevant industry experience in biologics.
• Experience leading formulation development for late-stage programs.
• Ability to drive development with regulatory awareness.

Responsibilities

• Lead/ contribute to innovative approaches for biologics sterile product development.
• Guide formulation development activities in matrix teams to define robust processes.
• Demonstrate technical leadership on program development teams and drive milestones.
• Mentor scientists and support tech transfers at external sites.
• Contribute to patents, publications and regulatory filings.

Skills

Biologics

Formulation development

Design of Experiments

Regulatory filings

Team leadership

Communication

Education

Ph.D. in Chemical Engineering or Biomedical Engineering or Pharmaceutical Sciences

B.S./M.S. in Engineering or Pharmaceutical Sciences

Job description

Merck & Co., Inc. in Rahway, NJ is seeking an experienced leader in biologics sterile product development to drive late-stage formulation and process development for non-oral dosage forms, including injectables and implants.

You will collaborate across functions to design robust drug product strategies and ensure scalable manufacturing. The role emphasizes technical leadership, strategic planning, and documentation for regulatory filings, with opportunities to mentor scientists and contribute to