Description
Plan, direct, and coordinate analytical laboratory services supporting R&D, manufacturing, and regulatory needs, ensuring method development/validation, data integrity, compliance, and timely client deliverables.
- • Collaborate with scientists, QA, manufacturing, and clients to scope studies, set analytical strategies, and provide technical guidance.
- • Build and manage client relationships; explain proposals, set specifications, present results, and communicate project status.
- • Plan and direct analytical testing, method development, validation, and sample throughput.
- • Design and coordinate investigations, method selection, validation protocols, and execution.
- • Review project progress; audit raw data; approve test reports, certificates of analysis, and data packages.
- • Hire, schedule, mentor, and evaluate analysts and laboratory staff.
- • Translate business goals into service roadmaps, KPIs, capacity plans, and continuous improvement initiatives.
- • Develop and enforce SOPs, data integrity practices (ALCOA+), and quality systems (GLP/GMP/ISO 17025).
- • Introduce new instruments or methods; oversee IQ/OQ/PQ; train staff on instrumentation and software.
- • Oversee sample receipt, chain of custody, LIMS records, and turnaround times.
- • Perform complex analyses and troubleshoot methods, instruments, and data issues as needed.
- • Lead investigations for deviations, OOS/OOT results, and implement CAPAs.
- • Support regulatory inspections and client audits; ensure compliance documentation is current.
- • Manage budgets, inventory, capital projects, vendor contracts, and service agreements.
- • Promote EHS compliance, chemical hygiene, and lab safety; ensure waste management and hazard communication.
- • Present technical updates to clients, leadership, and at industry meetings.
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Tasks & skills:
O*NET occupational data (work activities, skills, knowledge).
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Last reviewed: Jan 2026