QC - Microbiology Manager

Manages the QC Microbiology team and provides critical microbiology support to manufacturing and facilities.

 

Essential Duties and Responsibilities:

• Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of raw materials, intermediates (in process) and bulk drug substance in a cGMP regulatory environment.
• Implement and manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
• Responsible for all QC microbiological aspects of cGMP compliance and sample analysis.
• Design and oversee microbiological validations as needed for drug substance, in-process controls and buffers.
• Manage the design, validation and execution of the clean utilities qualification and re-qualification program.
• Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice on QC related topics as needed.
• Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
• Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Review and approve method protocols, reports and SOPs.
• Assist in the preparation for internal/customer/regulatory inspections.
• Ensure a safe working environment within the laboratory.
• Proactively identify and implement lab process improvements, lean initiatives.
• Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
• Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
• Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.
• Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
• May be required to work shift.

Education and Experience:

BS/BA in Microbiology or closely related field with 6+ years' experience in microbiology lab, preferably in the pharmaceutical or biotech industry with 3+ years' experience in a leadership role in microbiology laboratory manageme

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