Job Details

What We're Looking For

We are seeking a dynamic and experienced Director of Microbiology to lead our microbiology department. The 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 Do

• Lead 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.
• Undertake any other duties as required.

Who You Are

• Ph.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.
• Expert with pharmaceutical microbial testing and related equipment/instrument. This includes hands-on experience in USP compliant sterile and non-sterile microbiological testing procedures for pharmaceuticals.
• In depth knowledge of technical details regarding testing methodologies such as USP <51>, USP <60>, USP <61>, USP <62>, USP <71>, USP <85>, rapid alternative microbiology testing methods (For bioburden & sterility testing), solid phase flow cytometry, whole genome sequencing, etc.
• Knowledge of microbiological practices such as described in USP <1117>, and FDA's Bacteriological Analytical Manual
• Knowledge of microbiological criteria for drug products such as described om USP <1111>.
• Experience with microbial contamination control within aseptic processes.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Wide knowledge of analytical microbiological methods and electronic systems used in the Microbiology Lab.
• Excellent leadership, communication (written and oral), and interpersonal skills.
• A record of peer-reviewed technical publications is desirable.
• Strong analytical and problem-solving ability.
• Ability to effectively manage multiple projects and prioritize tasks in a fast-paced customer-oriented environment.
• Experience working in a contract testing laboratory or similar industry is preferred.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

Who We Are

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.

Equal Opportunity Employer
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