Director, Externalized Biologics Analytics & Strategy

Merck; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck in Rahway, NJ is seeking a Senior Leader to head the Pharmaceutical Analysis and Digital Technologies group. You will oversee a team of 10–12 scientists, directing externalized analytical deliverables for biologics, ADCs, and vaccines across development stages.

You will drive externalization strategy, collaborate with QA, Process, and Manufacturing, and build capabilities with external partners. Strong leadership and GMP knowledge are essential.

Qualifications

• Ph.D. with at least 8 years of experience, or master's 10+ years, or bachelor's 15+ years.
• Strong background in large molecule analytical development and externalization.
• Excellent communication and project management skills are essential.

Responsibilities

• Execute externalization strategy and optimize operating model.
• Oversee analytical deliverables from external partners to ensure GMP compliance.
• Manage transfer of methods to commercial QC labs for registrational targets.
• Ensure high-quality documentation from external partners.
• Collaborate with internal stakeholders to shape future team direction.
• Develop talent and align development plans with individual strengths.

Skills

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

Adaptability

Education

Ph.D. with minimum 8 years experience

Master's with minimum 10 years experience

Bachelor's with minimum 15 years experience

Tools

GMP knowledge

HA guidelines familiarity

Job description

Merck in Rahway, NJ is seeking a Senior Leader to head the Pharmaceutical Analysis and Digital Technologies group. You will oversee a team of 10–12 scientists, directing externalized analytical deliverables for biologics, ADCs, and vaccines across development stages.

You will drive externalization strategy, collaborate with QA, Process, and Manufacturing, and build capabilities with external partners. Strong leadership and GMP knowledge are essential.