Senior Biologics Upstream Process Leader & Commercialization

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

Benefits offered by this job

Annual bonus

Long-term incentives

Medical benefits

401(k)

Job summary

Merck & Co., Inc. is seeking a Director/Principal Scientist in Biologics Drug Substance Commercialization (BDSC) to drive late-stage upstream cell culture development and commercialization.

You will lead a team, oversee process characterization, tech transfer, and regulatory readiness for licensure and commercial supply. Join a cross‑functional environment with Manufacturing, Quality, and Regulatory partners, shaping strategy and mentoring scientific staff.

Qualifications

• Deep expertise in cell culture process development for biologics.
• Experience supporting commercialization and late-stage programs.
• Proven ability to lead teams and coordinate cross-functional work.

Responsibilities

• Lead upstream and/or integrated drug substance teams supporting late-stage and commercial programs.
• Provide technical leadership for laboratory and manufacturing scale studies.
• Author and review regulatory documentation for submissions.
• Drive technology transfer to internal and external sites.
• Mentor and develop upstream scientists and staff.

Skills

Cell culture process development

Biologics commercialization

Leadership

Technology transfer

Regulatory submissions

Cross-functional collaboration

GMP manufacturing

Scale-up

Analytical methods

Education

PhD in Chemical/Biological Engineering

MS in Chemical/Biological Engineering

BS in Chemical/Biological Engineering

Job description

Merck & Co., Inc. is seeking a Director/Principal Scientist in Biologics Drug Substance Commercialization (BDSC) to drive late-stage upstream cell culture development and commercialization.

You will lead a team, oversee process characterization, tech transfer, and regulatory readiness for licensure and commercial supply. Join a cross‑functional environment with Manufacturing, Quality, and Regulatory partners, shaping strategy and mentoring scientific staff.