The Microbiology Manager reports to the Associate Director, Microbiology and primary responsibilities will be to manage and coordinate staff performing microbiological testing in support the manufacturing of aseptically processed, terminally sterilized pharmaceutical products and oral solid dosage products. Provides technical leadership, daily oversight and subject matter expertise as needed to manage the QC microbiology laboratory functions:

• Microbiological testing of raw-materials, in-process materials and finished products
• Developing and validating microbial test methods for bioburden, sterility, liquid particle counts and endotoxin
• Reading and reviewing environmental monitoring data

In this role you will be the primary contact for the microbiology laboratory, collaborating with personnel outside of the department, facilitating timely and right the first time data management and reporting and assuring testing is completed in support of manufacturing timelines and regulatory standards.

Major Responsibilities

• Help in Preparation of OpEx and Capex Budget for the microbiology laboratory. Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site
• Take appropriate steps to reduce waste and losses in the analysis process and build improved efficiency
• Provide day-to-day tactical and logistic support for coordinating execution of activities and/or projects according to timeliness
• Supervise the testing of in-process, final product and stability samples
• Review and approve data, procedures and testing in support of batch release
• Anticipate and respond to technical problems, coordinate investigations and help develop appropriate solutions, assuring compliance is maintained and timeliness are met.
• Write, Evaluate and approve deviations/ investigations reports
• Supervise, coach and develop staff to ensure all activities are performed and documented according to policies, procedures and consistent with cGMP and regulatory requirements
• Conduct annual reviews for all direct reports and assist in setting performance objectives and developmental plans
• Prepare laboratory for internal and external audits and participate in internal and external audit as required as SME
• Write, revise and update standard Operating procedure as necessary to ensure compliance
• Ensure annual maintenance contact renewal (if any), for calibration of laboratory instruments
• Ensure requalification and calibration of instruments in micro lab as per the schedule
• Order and maintain inventory of the laboratory reagents, media and supplies as necessary to ensure smooth operations
• Procure and qualify new equipment in the laboratory
• Review of change controls, incidents, protocols and deviations of other departments related to microbiology
• Must be able to successfully complete gown qualification program
• Responsible for microbiology laboratory personnel performance
• Responsible for coordination with Production / R&D/QA/QC for various activities related to microbiology laboratory
• Interact with different departments in case of OOT, OOAC, OOAL and OOS observations related to microbiology
• Train and implement cGMP practices related to microbiology at all the manufacturing and related departments
• Stay current with regulatory and compliance requirements for the microbiology laboratory and update SOPs as necessary to ensure compliance
• Suggest continuous improvement for laboratory procedures and practices

Qualifications

• Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent required. Master’s degree in microbiology or equivalent, preferred
• Requires 5-7 of years of experience in the field of Pharmaceutical (formulation facility), Background of functions of Microbiology and experience of working with Injectable facility.
• Proven ability to quickly learn and understand complex topics
• Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience
• Microbiology laboratory skills and knowledge, such as aseptic techniques, is required
• Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines
• Superior written and verbal communication skills, with a keen eye for detail
• Proven ability to prioritize and handle multiple projects simultaneously
• Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis
• Proven ability to prioritize and handle multiple projects simultaneously
• Strong organizational, analytical, troubleshooting and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis
• Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
• Excellent verbal and written communication
• Experience handling regulatory audits