Director, Quality Control Chemistry & Raw Materials

Merck · Wilmington (biotech), DE

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QualityFull-time$173k–$273kCompany career page

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Role summary

Director-level role leading quality control chemistry and raw materials operations at a new biotech manufacturing facility in Wilmington, Delaware. Responsible for laboratory start-up, analytical program oversight, team leadership, and ensuring compliant testing for biologics and antibody-drug conjugates.

What they're looking for

Bachelor's degree in biochemistry, chemistry, or equivalent technical discipline; Master's or PhD preferred
Minimum 12 years biotechnology or pharmaceutical industry experience; ADC experience preferred
Technical expertise in separations, method validation, and technology transfer for biologics
Experience managing raw materials testing programs and supplier quality in regulated environments
Proven QC laboratory team leadership and regulatory inspection experience
Knowledge of ICH Q2/Q14, USP <1220>, and quality systems
Project management, risk assessment, and cross-functional stakeholder engagement skills

What you'll be doing

Lead chemistry and raw materials laboratory start-up including design, equipment qualification, validation, and compliant workflows
Establish testing capabilities for raw materials, in-process samples, and product analysis aligned with global standards
Manage day-to-day operations ensuring cGMP compliance, regulatory readiness, and inspection-ready documentation
Lead investigations of out-of-specification events, stability trends, and deviations; drive root cause analysis and corrective actions
Build, develop, and manage high-performing analytical team; oversee budgets, capital planning, and continuous improvement initiatives

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