Senior Biologics Cell Culture Commercialization Lead

MSD; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Biologics Cell Culture Commercialization Leader to guide strategic direction and regulatory filings for late-stage biologics programs. Lead cross-functional teams to advance process development, tech transfer, and licensure while driving business improvements and a culture of excellence.

The role emphasizes leadership of CMC teams, collaboration with global manufacturing, and accountability for program milestones in a fast-paced, regulated environment.

Qualifications

• Proven leadership of functional teams in biologics development & commercialization.
• Deep expertise in cell culture commercialization and manufacturing operations.
• Strong understanding of regulatory requirements.
• Ability to lead without authority, build trust, and inspire accountability.

Responsibilities

• Technical Strategy: Deliver robust DS strategies for successful commercialization and oversight of cell culture process development and regulatory filings.
• Technical leadership: Independently conduct and direct planning, execution, analysis and documentation of cell culture process commercialization.
• CMC RA: Experience supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections.
• Leadership: Establish and mentor Cell Culture CMC teams and align resources to priorities.
• Cross-Functional Collaboration: Unite diverse teams to achieve program goals while promoting compliance and safety.
• Project Management: Drive schedules, set priorities, and monitor performance metrics.

Skills

Biologics

Bioprocessing

CMC Biologics

Commercial Developments

Commercialization

Leadership

Maintenance Supervision

Mammalian Cell Culture

Manufacturing Scale-Up

Mentorship

Regulatory Compliance

Regulatory Processes

Situational Leadership

Education

Bachelor's in Chemical Engineering, Bioengineering, Biological Engineering, or related field

Master's in Chemical Engineering, Bioengineering, Biological Engineering, or related field

Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or related field

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Biologics Cell Culture Commercialization Leader to guide strategic direction and regulatory filings for late-stage biologics programs. Lead cross-functional teams to advance process development, tech transfer, and licensure while driving business improvements and a culture of excellence.

The role emphasizes leadership of CMC teams, collaboration with global manufacturing, and accountability for program milestones in a fast-paced, regulated environment.