Director of Pharmaceutical Laboratory Services
About The Position
We are looking for an experienced, scientifically rigorous, and commercially minded Director of Pharmaceutical Laboratory Services to lead laboratory operations within the pharmaceutical industry. We are a pharmaceutical company committed to producing high-quality, safe, and effective medicines in accordance with applicable regulatory and quality standards. Our operations depend on robust scientific expertise, reliable laboratory services, strong technical governance, and a culture of quality across every stage of manufacturing and product release. We are looking for an experienced Director of Pharmaceutical Laboratory Services to lead the development and growth of a pharmaceutical analytical testing laboratory. This person will be responsible for building laboratory capabilities, developing quality systems, overseeing testing and equipment, hiring and managing laboratory staff, and ensuring compliance with FDA, cGMP, and USP requirements. The ideal candidate is a hands-on laboratory leader with strong experience in pharmaceutical testing, analytical chemistry, quality control, and laboratory operations.
Requirements
- Bachelor's degree or higher in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Microbiology, Biochemistry, or a related field. Advanced degree preferred.
- 5+ years of pharmaceutical analytical testing or laboratory experience.
- 5+ years of laboratory leadership experience.
- Experience building, expanding, or significantly improving a pharmaceutical laboratory.
- Strong knowledge of pharmaceutical testing and analytical method development/validation.
- Experience working in a cGMP and FDA-regulated environment.
- Experience with laboratory audits or regulatory inspections.
- Experience with laboratory equipment such as HPLC, GC, LC-MS, ICP-MS, FTIR, UV-Vis, or similar technologies.
- Strong understanding of laboratory quality systems and data integrity.
- Strong leadership, communication, and problem-solving skills.
Responsibilities
- Lead the development and growth of the pharmaceutical laboratory.
- Evaluate current laboratory equipment, processes, staffing, and capabilities.
- Develop plans for new pharmaceutical testing services.
- Select, purchase, install, and qualify laboratory equipment.
- Develop, transfer, and validate analytical testing methods.
- Oversee pharmaceutical testing, including: Potency and assay, Identity and purity, Sterility, Microbial limits, Bacterial endotoxins, Dissolution, Stability testing Raw material and finished product testing
- Develop and maintain laboratory quality systems.
- Ensure compliance with FDA, cGMP, USP, ICH, and data-integrity requirements.
- Oversee investigations, deviations, CAPA, OOS results, and change controls.
- Prepare the laboratory for customer audits and regulatory inspections.
- Hire, train, and manage analytical chemistry and microbiology staff.
- Review and approve SOPs, testing methods, validation reports, and Certificates of Analysis.
- Work with leadership on budgets, equipment purchases, staffing, pricing, and business growth.
- Help identify opportunities to expand into additional pharmaceutical and biopharmaceutical testing services.
Benefits
- Health
- Dental
- 401(k)
- PTO
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What This Job Offers
Job Type
Full-time
Career Level
Director
