Senior Regulatory CMC Biologics Lead Scientist

HireLifeScience; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Scientist (R3) for Regulatory CMC Biologics to lead regulatory CMC projects and ensure milestone delivery across development and life cycle.

You will develop robust global CMC strategies, manage regulatory documentation, and coordinate with cross-functional teams, while maintaining strict compliance. Hybrid work option with comprehensive benefits.

Qualifications

• At least 5 years in Regulatory CMC with biologics or vaccine substance experience.
• Experience shaping global regulatory strategies and risk assessment.
• Strong leadership and cross-functional collaboration abilities.

Responsibilities

• Serve as Regulatory CMC Project Lead and deliver regulatory milestones.
• Develop robust CMC regulatory strategies and assess global requirements.
• Manage CMC documentation: INDs, BLA/MAA, and responses to questions.
• Identify and elevate potential regulatory issues to leadership.
• Maintain strict compliance across activities.

Skills

Regulatory CMC

Biologics

Regulatory Affairs

Leadership

Project management

Education

B.S. in science or related field (advanced degree preferred)

Tools

eCTD

Job description

Merck & Co., Inc. in Rahway, NJ, seeks a Senior Scientist (R3) for Regulatory CMC Biologics to lead regulatory CMC projects and ensure milestone delivery across development and life cycle.

You will develop robust global CMC strategies, manage regulatory documentation, and coordinate with cross-functional teams, while maintaining strict compliance. Hybrid work option with comprehensive benefits.