Director, Chemistry & Raw Materials QC – Biologics

MSD Malaysia; Wilmington (DE); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays

Job summary

Merck in Wilmington seeks a Director of Chemistry & Raw Materials to lead analytical chemistry testing for biologics at the new QC site. You will drive method development, validation, and transfer, ensuring GMP compliance and regulatory readiness across the supply chain.

With 12+ years in biotech/pharma, you will build and mentor a high-performing team, manage budgets, and partner with R&D, Manufacturing and Regulatory to support CMC filings and inspections.

Qualifications

• Bachelor’s degree in a technical discipline with 12+ years in biotech/pharma.
• Experience with separations, method validation and tech transfer for biologics; ADC experience preferred.
• Strong leadership, budgeting and cross-functional stakeholder engagement; regulatory inspection experience preferred.

Responsibilities

• Lead startup activities for chemistry and raw materials labs, including design, readiness, equipment qualification and validation.
• Oversee chromatographic and separation-based method execution and lifecycle management.
• Develop and maintain laboratory capability strategy and capital plans.
• Lead investigations of OOS/OOT, CAPA and root-cause analysis; support regulatory filings.

Skills

Analytical Instrumentation

Analytical Method Transfer

Analytical Testing

Biochemistry

Chromatography

Quality Control Systems

People Leadership

Technical Transfer

Education

Bachelor's degree in Chemistry/Biochemistry

Master’s or PhD preferred

Tools

Laboratory Automation

Job description

Merck in Wilmington seeks a Director of Chemistry & Raw Materials to lead analytical chemistry testing for biologics at the new QC site. You will drive method development, validation, and transfer, ensuring GMP compliance and regulatory readiness across the supply chain.

With 12+ years in biotech/pharma, you will build and mentor a high-performing team, manage budgets, and partner with R&D, Manufacturing and Regulatory to support CMC filings and inspections.