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
Monroe, North Carolina