Biologics Upstream Commercialization Leader

MSD; West Point (PA); In loco; USD 173.000 - 273.000; Tempo pieno

Descrizione del lavoro

MSD is seeking a Principal Scientist/Director for Biologics Drug Substance Commercialization to lead late‑stage and commercial biologics programs. You will oversee upstream processing, science strategy, and cross‑functional collaboration to enable licensure and manufacturing readiness.

The role emphasizes leadership, mentorship, and hands-on process development with an emphasis on scale‑up, regulatory submissions, and continuous improvement in a fast-paced environment.

Competenze

• BS/MS/PhD with substantial industry experience in biologics.
• 16+ years (BS), 12+ years (MS), or 8+ years (PhD) of relevant industry experience.
• Deep expertise in cell culture process development and commercialization.
• Experience supporting biologics commercialization and late-stage development.

Mansioni

• Provide scientific and technical leadership for upstream cell culture and drug substance programs.
• Lead technology transfer, process validation, and license readiness activities.
• Collaborate across Manufacturing, Quality, Regulatory, and external partners.
• Mentor scientists and drive a culture of innovation and operational excellence.

Conoscenze

Bioprocess Engineering

Biologics Manufacturing

Cross-Functional teamwork

Process Characterization

Regulatory submissions

Leadership

Technology Transfer

Process Development

Lean leadership

Mentorship

Formazione

BS in Chemical/Biochemical Engineering or related

MS in Chemical/Biochemical Engineering or related

PhD in Chemical/Biochemical Engineering or related

Strumenti

Technology Transfer

Descrizione del lavoro

MSD is seeking a Principal Scientist/Director for Biologics Drug Substance Commercialization to lead late‑stage and commercial biologics programs. You will oversee upstream processing, science strategy, and cross‑functional collaboration to enable licensure and manufacturing readiness.

The role emphasizes leadership, mentorship, and hands-on process development with an emphasis on scale‑up, regulatory submissions, and continuous improvement in a fast-paced environment.