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What We're Looking For
The Microbiology Manager is primarily focused on ensuring regulatory compliance, policy & procedural compliance, and oversight of technical issues relating to tests conducted in the Microbiology lab (Sterile & Non-Sterile). Additionally, the ideal candidate for this position is responsible for the acquisition, training, development, and retention of employees.
What You Will Do
• The ideal candidate for this position will schedule testing of the incoming samples, oversee microbial testing, EM monitoring of the aseptic areas, general laboratory operations (ordering supplies, culture media, operating laboratory equipment, sample receipt, lab notebooks, records and data, authoring/review/integrity following good documentation practices), gowning qualifications, aseptic operator qualifications, and contamination control activities
• Provide technical support for facility micro-contamination control
• Ensure Micro-Lab EHS compliance
• Ensure timely completion of testing (e.g., DS, DP release and stability testing, raw materials testing) to ensure timely generation and reporting of test results
• 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 4 to 6 years of experience. Masters Microbiology, Molecular Biology or Cell Biology with 10 years of experience in GMP environment preferably pharmaceutical product analysis. Ph.D. is preferred.
• Minimum of 3 years working experience and 1 year's 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.
• Familiar with the USP testing methodologies such as USP , USP , USP , USP , USP , USP etc.
• Experience with microbial contamination control of aseptic process
• 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 Micro-Lab.
• Strong leadership/team management skills and experience.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Excellent project management skills.
• Hands-on approach, with a ‘can do' attitude.
• Ability to prioritize, demonstrating good time management skills.
• 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 .
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