Biologics Upstream Leader - Commercialization & Scale-Up

MSD; West Point (PA); On-site; USD 173,000 - 273,000; Full time

Job summary

MSD is seeking a Principal Scientist/Director in Biologics Drug Substance Commercialization to lead upstream cell culture programs and drive late-stage and commercial efforts. You will mentor teams, shape process development, and oversee tech transfer to ensure licensure and scalable manufacturing.

The role requires deep upstream processing expertise, proven leadership, and experience with regulatory submissions and cross-functional collaboration across Manufacturing, Quality, and External

Qualifications

• Deep expertise in cell culture process development and commercialization.
• Experience leading teams on late-stage and commercial biologics programs.
• Proven ability to drive process development, tech transfer, and regulatory documentation.

Responsibilities

• Provide scientific and technical leadership for upstream and integrated drug substance programs across late-stage and commercial efforts.
• Oversee technology transfer to internal and external sites, including scale-up and validation activities.
• Drive cross-functional collaboration with QA, Regulatory, and external partners to enable licensure and manufacturing readiness.
• Mentor and develop a team of upstream scientists to foster innovation and operational excellence.
• Lead strategic initiatives related to platform evolution, digital systems, and long-term capabilities.

Skills

Upstream biologics processing

Leadership & mentoring

Technology transfer

Process characterization

Regulatory submissions

Education

BS/MS/PhD in Chemical/Biological Engineering

Job description

MSD is seeking a Principal Scientist/Director in Biologics Drug Substance Commercialization to lead upstream cell culture programs and drive late-stage and commercial efforts. You will mentor teams, shape process development, and oversee tech transfer to ensure licensure and scalable manufacturing.

The role requires deep upstream processing expertise, proven leadership, and experience with regulatory submissions and cross-functional collaboration across Manufacturing, Quality, and External