Director of Microbiology will be responsible for overseeing all aspects of microbiological testing related to pharmaceuticals and process environments, ensuring compliance with regulatory standards, implementing quality control measures, and providing technical expertise to support our clients' needs. Additionally, the ideal candidate for this position is responsible for the acquisition, training, development, and retention of employees.
- What You Will DoLead and manage the microbiology department, including staff recruitment, training, and performance evaluation for sterile lab, non-sterile lab and R&D lab.
- Develop and implement strategies to optimize laboratory operations and ensure efficient workflow.
- Oversee the execution of microbiological testing procedures, including microbial identification, enumeration, detection of objectionable microorganisms, antimicrobial effectiveness testing and preservatives effectiveness testing.
- Ensure compliance with relevant regulatory requirements (e.g., FDA, ISO) and accreditation standards (e.g., ISO 17025).
- Collaborate with clients to understand their testing requirements and provide technical support and guidance.
- Review and approve test data, reports, and documentation generated by the microbiology department.
- Stay abreast of industry trends, new technologies, and regulatory changes related to microbiological testing.
- Ensure appropriate investigation of OOS, discrepancies, errors, failures requiring documented review and action.
- Participate in internal and external GMP audits where possible.
- Manage microbial methods transfer and methods validation activities, including transfer/validation strategy and approval of protocols and reports.
- Introduce advanced concept of microbiology laboratory to keep the laboratory forward-looking and competitive in the industry
- Manage, motivate, coach and mentor direct reports
- Who You ArePh.D. in Microbiology, Molecular Biology or Cell Biology with at least 10 years (or MS with at least 15 years) of directly relevant experience (excluding graduate research) in GMP environment, preferably pharmaceutical product analysis.
- Minimum of 5-7 years of team management experience in an FDA-regulated contract laboratory or biotechnology & pharmaceutical company with progressive levels of responsibility are required.