Supervisor, Microbiology
On-siteNashville, Tennessee, United States
Job Summary
Oversee microbiological testing activities for raw materials, components, drug products, stability, and validation samples. Manage environmental monitoring, aseptic process simulation, and gowning qualification programs while ensuring laboratory compliance with cGMPs, FDA/ICH guidance, and internal SOPs. Lead and mentor analysts, foster continuous improvement, and prepare protocols, technical reports, and documentation for CMC activities. Review laboratory data for accuracy, resolve project-related issues, and ensure personnel and equipment compliance. Prepare annual laboratory budgets and conduct performance assessments. Serve as a subject matter expert and lead cross-functional teams supporting formulation, process development, and scale-up. Work in regulated development environments, maintaining audit-ready standards.
Required Qualifications
- Bachelor's degree in biology, or related science
- 8-10 years of experience in a pharmaceutical laboratory management role
- Strong knowledge of SOPs, laboratory procedures, FDA and ICH guidance, USP regulations, microbiological testing techniques, and cGMP
- Strong track record of leadership skills and influence
- Strong interpersonal skills
- Ability to work cross-functionally both internally and externally
- Must be a leader, mentor, and self-motivated to develop a high performing team
- Must possess excellent written and verbal communication skills, interpersonal skills, management skills, strong work ethic, and organizational skills
- Demonstrated analytical and problem-solving skills
- Must be able to lift up to 15 pounds at times
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