Analytical Laboratory Manager
On-site · Mooresville, North Carolina, United States
Job Summary
The Analytical Laboratory Manager supervises a team of analytical chemists and oversees method development, validation, and method verification activities for intermediates, final products, formulation prototypes, pre-commercial stability samples, investigational samples, and plant trial samples, ensuring compliance with cGMPs, GLPs, and SOPs. Responsibilities include planning and supervising analytical development activities, leading investigations and problem solving, managing method development/validation and testing workflows, maintaining accurate documentation, reviewing and approving protocols/reports, ensuring audit-ready safety and housekeeping, collaborating with QC, R&D, and Project Management, supporting lifecycle management of analytical methods, coordinating method transfers, driving AD personnel scheduling to meet cycle times, and developing KPIs and SOPs. The role also includes equipment maintenance/calibration, budget oversight, and People Leader responsibilities such as hiring/training, performance appraisal, and maintaining an inclusive workplace.
Required Qualifications
- Bachelor’s degree in chemistry, biochemistry, or related science
- 10 years’ experience in a quality control laboratory role or equivalent
- 5 years’ leadership/management experience
- Experience with analytical techniques (e.g., UPLC, GC, UV, AAS, FTIR, ICP-MS, dissolution)
- Knowledge of cGMP, GLPs, SOPs
- Ability to lead, plan, and coordinate analytical development
- Strong documentation and data review skills
- Proficiency with MS Office tools
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