Biologics Sterile Product Lead & Innovator

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

Benefits offered by this job

Medical, dental, vision insurance

Retirement benefits including 401(k)

Paid holidays and vacation

Compassionate and sick days

Job summary

Merck & Co., Inc. in Rahway, NJ, is seeking an Associate Principal Scientist (R4) to lead biologics sterile product development, including designing experiments, developing robust drug products, and guiding regulatory filings.

The role requires strong leadership within matrix teams and a deep understanding of formulation science. The successful candidate will mentor scientists, drive innovation, and coordinate activities with external sites, ensuring milestones are met and knowledge is shared

Qualifications

• Experienced in biologics process development and characterization for late-stage programs.
• Capable of leading formulation development activities in matrix team environments.
• Recognized as a technical expert with proven ability to identify and develop innovative ideas.

Responsibilities

• Lead/contribute towards innovative approaches for biologics sterile product development through experimental designs and data analysis.
• Support both early and late-stage development candidates including screening and development of robust drug product composition and scalable processes.
• Build deep fundamental knowledge around the drug product to ensure milestones and regulatory documentation are completed.
• Lead program development teams and collaborate across functions to drive milestones.
• Mentor scientists and drive organizational strategic objectives.

Skills

Biologics process development

Late-stage formulation development

Matrix team leadership

Regulatory filing experience

Scientific communication

DOE (Design of Experiments)

Education

Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline

B.S. or M.S. in Engineering, Pharmaceutical Sciences or related discipline

Job description

Merck & Co., Inc. in Rahway, NJ, is seeking an Associate Principal Scientist (R4) to lead biologics sterile product development, including designing experiments, developing robust drug products, and guiding regulatory filings.

The role requires strong leadership within matrix teams and a deep understanding of formulation science. The successful candidate will mentor scientists, drive innovation, and coordinate activities with external sites, ensuring milestones are met and knowledge is shared