Director, External Analytics & Capabilities

Merck & Co.; West Point (PA); In loco; USD 190.000 - 270.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in West Point, PA, USA, seeks a transformative leader to head the Pharmaceutical Analysis and Digital Technologies team within Development Sciences and Clinical Supplies.

You will guide a group of 10–12 scientists, driving externalized analytical deliverables for biologics, ADCs, and vaccines across development stages. The role demands SME-level expertise in large molecule CMC, GMP, and HA guidelines, with a strong focus on cross-functional collaboration with Process, Quality

Competenze

• Ph.D. with at least eight years of relevant experience or an equivalent combination.
• Master's degree with at least ten years of experience or a bachelor's with at least fifteen years.
• Demonstrated expertise in large molecule CMC development and externalization strategies.

Mansioni

• Execute externalization strategy and optimize operating model for external partners.
• Oversee analytical deliverables and quality control for drug substance/product with GMP compliance.
• Develop external analytical capability with internal SMEs and strategic partners.
• Transfer methods to commercial QC labs supporting registrational targets.
• Ensure high-quality external documentation aligned with regulatory expectations.
• Collaborate with leadership to shape future direction and pipeline delivery.

Conoscenze

People Leadership

People Management

Team Leadership

Analytical Chemistry

Analytical Method Development

Analytical Thinking

Biologics License Application (BLA)

Chemistry

Chromatographic Techniques

Commercialization

Drug Development

Lab Research

Pipeline Development

Regulatory Compliance

Regulatory Submissions

Scientific Analysis

Scientific Research

Formazione

Ph.D. with 8+ years experience

M.S. with 10+ years experience

B.S. with 15+ years experience

Descrizione del lavoro

Merck & Co. in West Point, PA, USA, seeks a transformative leader to head the Pharmaceutical Analysis and Digital Technologies team within Development Sciences and Clinical Supplies.

You will guide a group of 10–12 scientists, driving externalized analytical deliverables for biologics, ADCs, and vaccines across development stages. The role demands SME-level expertise in large molecule CMC, GMP, and HA guidelines, with a strong focus on cross-functional collaboration with Process, Quality