Lab Director

About the role

The Laboratory Director will provide scientific, technical, and operational leadership for a microbiology/pharmaceutical and quality-control laboratory. The successful candidate must have industry experience with stability studies, sterility testing, antimicrobial effectiveness testing (AET), stability programs, and other applicable United States Pharmacopeia (USP) procedures. The role requires an independent and detail-oriented leader with strong knowledge of pharmacology, pharmaceutical product testing, regulatory compliance, and laboratory operations. Experience in analytical chemistry is strongly preferred.

Roles & responsibilities

• Direct daily laboratory operations, including personnel, workflow, scheduling, equipment, documentation, supplies, and project priorities
• Provide technical oversight for stability studies, sterility testing, AET, microbial enumeration, specified-microorganism testing, bioburden, environmental monitoring, method suitability, growth-promotion testing, and related USP procedures
• Oversee stability-study protocols, sample schedules, data review, trending, and reporting
• Ensure compliance with current USP requirements, cGMP, GLP, Good Documentation Practice (GDP), approved SOPs, and applicable regulatory expectations
• Serve as a subject-matter expert for relevant compendial procedures, including USP <51>, <61>, <62>, and <71>
• Review and approve test methods, protocols, laboratory data, technical reports, certificates of analysis, and SOPs
• Lead method verification, validation, transfer, troubleshooting, and continuous-improvement activities
• Investigate deviations, out-of-specification (OOS) and out-of-trend (OOT) results, laboratory incidents, and data-integrity concerns; develop appropriate CAPAs
• Recruit, train, supervise, and mentor laboratory personnel while promoting safety, accountability, and scientific rigor
• Support audits, inspections, client communications, regulatory responses, and cross-functional projects

Required education & experience

• PhD in microbiology, pharmaceutical microbiology, pharmacology, pharmaceutical sciences, biology, biochemistry, or a related scientific field, with at least 1-2 years of relevant pharmaceutical or regulated-industry experience; or MS in a relevant scientific field with a minimum of 5-6 years of relevant pharmaceutical or regulated-industry experience
• Industry experience with USP compendial practices and pharmaceutical microbiology or quality-control laboratory operations is required
• Hands-on experience with sterility testing, stability testing, AET, and related USP procedures is required
• Knowledge of pharmacology, pharmaceutical dosage forms, and product-quality testing is required
• Education, training, or practical experience in analytical chemistry is strongly preferred
• Previous laboratory leadership or personnel-supervision experience is preferred

Skills & competencies

• Strong knowledge of aseptic technique, contamination control, cGMP, GLP, GDP, data integrity, and regulated laboratory documentation
• Ability to work independently, exercise sound scientific judgment, manage competing priorities, and resolve technical problems
• Strong leadership, organization, project-management, and decision-making skills
• Excellent written and verbal communication skills for interactions with employees, clients, auditors, and management
• Familiarity with laboratory software, electronic data systems, Microsoft Office, and preferably a laboratory information management system (LIMS)