Biologics Drug Substance Commercialization Lead

MSD Malaysia; Northern (KY); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Our Company’s Biologics Drug Substance Commercialization (BDSC) team seeks a Principal Scientist/Director to lead upstream cell culture process development and commercialization for late-stage and commercial programs.

You will mentor scientists, drive tech transfer and validation, and coordinate with QA, Regulatory, and external partners to support global manufacturing readiness and regulatory submissions.

Qualifications

• Deep technical expertise in cell culture process development and commercialization.
• Experience leading late-stage or commercial biologics programs.
• Strong leadership and collaboration skills within cross-functional teams.

Responsibilities

• Provide scientific leadership for upstream cell culture process development and commercialization.
• Oversee technology transfer, scale-up, validation, and continued process verification.
• Collaborate with Regulatory, QA, and external partners to support licensure and commercial manufacturing.

Skills

Biologics

Bioprocess Engineering

Leadership

Process Characterization

Regulatory Submissions

Education

PhD in Chemical Engineering/Biological Engineering

16+ years experience (BS)

Job description

Our Company’s Biologics Drug Substance Commercialization (BDSC) team seeks a Principal Scientist/Director to lead upstream cell culture process development and commercialization for late-stage and commercial programs.

You will mentor scientists, drive tech transfer and validation, and coordinate with QA, Regulatory, and external partners to support global manufacturing readiness and regulatory submissions.