Are you looking to make a direct impact with a pharmaceutical organization manufacturing sterile products? Our client is hiring a Microbiology Manager to manage and coordinate staff performing microbiological testing in support the manufacturing of aseptically processed, terminally sterilized pharmaceutical products.
Major Responsibilities :
- 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 dataHelp 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
- 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 Pharmaceuticals
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Job Type: Full-time
Pay: From $100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Relocation assistance
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Ability to Commute:
Ability to Relocate:
- Charlotte, NC: Relocate before starting work (Required)
Work Location: In person