Senior Director, Biologics Upstream Process Commercialization

MSD; Upper Gwynedd Township (Montgomery County); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in Pennsylvania's West Point area seeks a Principal Scientist/Director for Biologics Drug Substance Commercialization (BDSC).

This senior leader drives late-stage and commercial biologics programs, focusing on upstream cell culture, process development, and technology transfer to support licensure and manufacturing. The role leads a team, guides process characterization and regulatory readiness, and collaborates across functions to advance complex biologics programs with strong

Qualifications

• Deep expertise in upstream biologics processing and commercialization.
• Proven ability to lead late-stage development and regulatory submissions.
• Strong leadership, mentoring, and cross-functional collaboration.

Responsibilities

• Provide technical leadership for upstream processing and characterization.
• Lead technology transfer, scale-up, and validation for commercial programs.
• Collaborate across Manufacturing, Quality, and Regulatory teams.
• Drive regulatory readiness and continuous improvement initiatives.

Skills

Biologics

Process Development

Cell Culture

Regulatory Submissions

Cross-Functional Teamwork

Leadership

Process Characterization

Scale-Up

Lean Leadership

Education

BS in Chemical/Biological Engineering

MS in a related field

PhD in a related discipline

Tools

Technology Transfer

Job description

Merck & Co., Inc. in Pennsylvania's West Point area seeks a Principal Scientist/Director for Biologics Drug Substance Commercialization (BDSC).

This senior leader drives late-stage and commercial biologics programs, focusing on upstream cell culture, process development, and technology transfer to support licensure and manufacturing. The role leads a team, guides process characterization and regulatory readiness, and collaborates across functions to advance complex biologics programs with strong