Executive Director, Analytical Development and Quality Control Lead

Executive Director, Analytical Development and Quality Control Lead

Merck – Wilmington Biotech Campus

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company's biologics‑based medicines, including immuno‑oncology, and will establish internal capability to manufacture high‑potent compounds when full manufacturing operations begin in 2029.

The laboratory will bring together late‑stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle.

• Oversee recruiting and hiring of analytical development and QC staff.
• Manage, plan, and direct the QC laboratories, ensuring compliant testing and achievement of supply commitments.
• Ensure compliance with safety, environmental, and regulatory requirements, including CGMP regulations.
• Lead quality control oversight and leadership at the Wilmington Biotech Campus.
• Responsible for QC related testing: analytical, biochemistry, microbiology, environmental monitoring, raw materials.
• Lead implementation of stability program and laboratory investigations.
• Collaborate with R&D for transfer and validation of analytical methods and specifications.
• Provide site‑based analytical CMC information for filings, respond to regulatory queries.
• Develop and maintain SOPs, protocols, and technical reports.

BSc +15 years, MSc +12 years, or PhD +10 years experience in biotechnology and/or pharmaceutical industry.

• Significant experience in a comparable leadership role within analytical development and/or QC.
• Proven ability to lead a QC laboratory team with >5 years experience.
• Deep experience in analytical method development, validation and transfer for high‑potent compounds and biologics.
• Knowledge of compendial guidelines such as USP 1220, ICH Q2/Q14.
• Understanding of regulatory codes for US and international codes, standards, and practices.
• Recruitment and selection experience.

• Experience in ADC and biologics method validation and technology transfer.
• Release testing of clinical materials.
• Management of potent and sterile drug products.
• Commercialization of ADC programs through PPQ and launch.
• Drug substance/Conjugation analytical experience.

Salary: $ – $ plus potential annual bonus and long‑term incentive.

Benefits include medical, dental, vision, retirement, 401(k), paid holidays, vacation, sick days, and more.

We are an Equal Employment Opportunity Employer and provide equal opportunities for all applicants. We comply with affirmative action requirements for protected veterans and people with disabilities. For more information on your rights, visit our EEOC resources.

Requisition : R372525
Job Posting End Date: 01/12/2026