Biologics Upstream Process Lead—Commercialization

Merck & Co.; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co. is seeking a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC) in Rahway, NJ. The role leads upstream cell culture programs, guides process development, and manages technology transfer to support licensure and commercial manufacturing.

You will oversee a team of scientists, drive late-stage pipeline programs, and collaborate with Quality, Regulatory, and external partners to ensure regulatory readiness and successful supply of biologics products.

Qualifications

• Deep expertise in cell culture process development and commercialization.
• Ability to independently design, direct, execute, analyze, and document all stages of process development.
• Experience supporting biologics commercialization, including late-stage development and/or commercial manufacturing.
• Strong leadership and collaboration within cross functional, matrixed organizations.

Responsibilities

• Lead upstream drug substance teams supporting late-stage clinical and commercial programs with licensure in mind.
• Provide technical leadership for laboratory scale and manufacturing scale studies for characterization and validation.
• Author and review technical and regulatory documentation supporting submissions.
• Drive technology transfer activities to internal and external manufacturing sites, including scale-up and readiness.

Skills

Biologics Upstream

Process Development

Technology Transfer

Regulatory Submissions

Leadership

Education

BS in Chemical/Biological Engineering

MS in Chemical/Biological Engineering

PhD in Related Discipline

Job description

Merck & Co. is seeking a Principal Scientist/Director in Biologics Drug Substance Commercialization (BDSC) in Rahway, NJ. The role leads upstream cell culture programs, guides process development, and manages technology transfer to support licensure and commercial manufacturing.

You will oversee a team of scientists, drive late-stage pipeline programs, and collaborate with Quality, Regulatory, and external partners to ensure regulatory readiness and successful supply of biologics products.