Director of External Analytics & Biologics Operations

Merck & Co.; Rahway (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Merck & Co. in Rahway, NJ, is seeking a highly experienced leader to head the Pharmaceutical Analysis and Digital Technologies group within Development Sciences and Clinical Supplies.

You will manage a team of 10–12 scientists overseeing externalized analytical deliverables across Biologics, ADCs, and vaccines, ensuring regulatory compliance and seamless collaboration with internal Process, QA, and Manufacturing teams.

Qualifications

• Ph.D. with minimum 8 years experience or Master's with 10 years or Bachelor's with 15 years of experience.
• Pharmacology/CMC related expertise strongly preferred.
• Experience in overseeing large molecule analytical method development and external collaborations.

Responsibilities

• Execute externalization strategy and optimize operating model to deliver results.
• Oversee analytical deliverables for drug substance/product at external partners under GMP.
• Develop external analytical capabilities with internal SMEs.
• Transfer methods to commercial QC labs to support registrational targets.
• Ensure high-quality documentation consistent with compliance standards.
• Collaborate with ACO leadership to shape team direction and pipeline assets.

Skills

Adaptability

Analytical Chemistry

Analytical Method Development

Analytical Thinking

Biologics License Application (BLA)

Chemistry

Chromatographic Techniques

Commercialization

Drug Development

Laboratory Research

People Leadership

People Management

Pipeline Development

Regulatory Compliance

Regulatory Submissions

Scientific Analysis

Scientific Research

Team Leadership

Education

Ph.D. in a related field

Master's degree

Bachelor's degree

Job description

Merck & Co. in Rahway, NJ, is seeking a highly experienced leader to head the Pharmaceutical Analysis and Digital Technologies group within Development Sciences and Clinical Supplies.

You will manage a team of 10–12 scientists overseeing externalized analytical deliverables across Biologics, ADCs, and vaccines, ensuring regulatory compliance and seamless collaboration with internal Process, QA, and Manufacturing teams.