Biologics Upstream Process Leader – Commercialization

Merck; West Point (PA); On-site; USD 180,000 - 250,000; Full time

Job summary

Our Company is seeking a Principal Scientist/Director in Biologics Drug Substance Commercialization to drive late-stage and commercial programs in upstream cell culture. You will lead a team of scientists, guide high-impact process development, and manage technology transfer and validation to support licensure and commercial manufacture.

The role requires deep expertise in upstream biologics processing, demonstrated commercialization and scale-up experience, and strong leadership abilities.

Qualifications

• BS/MS/PhD in a relevant discipline with substantial industry experience.
• Experience in commercialization and scale-up of biologics.
• Hands-on experience with advanced antibody therapeutics.
• Familiar with regulatory submissions and analytical methods.
• Knowledge of cGMPs and lean leadership principles.

Responsibilities

• Provide technical leadership in upstream biologics processing and commercialization.
• Oversee process development and scale-up activities.
• Lead technology transfer and validation for licensure and commercial manufacturing.
• Ensure regulatory compliance and cross-functional collaboration.
• Drive innovation and operational excellence across the manufacturing division.

Skills

Leadership

Biologics processing

Process development

Regulatory compliance

Education

BS/MS/PhD in relevant discipline

Job description

Our Company is seeking a Principal Scientist/Director in Biologics Drug Substance Commercialization to drive late-stage and commercial programs in upstream cell culture. You will lead a team of scientists, guide high-impact process development, and manage technology transfer and validation to support licensure and commercial manufacture.

The role requires deep expertise in upstream biologics processing, demonstrated commercialization and scale-up experience, and strong leadership abilities.