Quality Control Lab Operational Readiness
Merck · Wilmington (biotech), DE
QualityFull-time$129k–$203kCompany career page
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Role summary
Quality Control Associate Director leading operational readiness for a new biologics manufacturing facility in Wilmington. The role oversees QC laboratory start-up planning, execution, and transition to routine operations, managing cross-functional workstreams including sample management, documentation, materials readiness, and inspection preparation.
What they're looking for
- Experience leading laboratory operational readiness or facility start-up initiatives
- Knowledge of QC laboratory operations, analytical testing, and GMP compliance
- Project management and cross-functional stakeholder coordination skills
- Proficiency with master scheduling, dependency mapping, and risk identification
- Experience with LIMS systems, sample management, and SOPs development
- Advanced degree in chemistry, life sciences, or related field preferred
What you'll be doing
- Develop and maintain QC laboratory operational readiness schedule aligned to site Integrated Master Schedule and milestones
- Define document readiness strategy and ensure SOPs, work instructions, and training materials meet start-up timelines
- Design end-to-end sample management operating model with workflows, LIMS functionality, and data integrity controls
- Establish stage-gates with entry/exit criteria and lead stakeholder reviews at critical project milestones
- Provide visibility to readiness risks, issues, and decisions through structured governance and performance dashboards
Privacy & handoff
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