Senior Principal Scientist, Sterile Drug Product Development

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

Job summary

Merck is seeking a Senior Scientist to lead biologics sterile product development, including formulation and process design for non-oral dosage forms. The role emphasizes experimental design, data analysis, and cross-functional collaboration to ensure scalable, compliant drug products from late-stage development to regulatory submission.

The candidate will mentor scientists, drive technology advancement, and support internal and external manufacturing, with responsibilities spanning project

Qualifications

• Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 3 years relevant industry experience.
• B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 8 years relevant industrial experience.

Responsibilities

• Lead/ contribute towards biologics sterile product development through experimental design and data analysis.
• Support early and late-stage development including robust drug product composition and scalable processes.
• Lead and mentor scientists; interface with stakeholders and drive milestones.
• Lead and sponsor process scale-up and tech transfers at external sites.
• Advance science and technology through publications, patents, and presentations.

Skills

Biologics process development

Formulation development

Design of Experiments (DOE)

Drug delivery

Regulatory filings

Project leadership

Scientific collaboration

Technical expert

Education

Ph.D. in Chemical Engineering

Ph.D. in Biomedical Engineering

Job description

Merck is seeking a Senior Scientist to lead biologics sterile product development, including formulation and process design for non-oral dosage forms. The role emphasizes experimental design, data analysis, and cross-functional collaboration to ensure scalable, compliant drug products from late-stage development to regulatory submission.

The candidate will mentor scientists, drive technology advancement, and support internal and external manufacturing, with responsibilities spanning project