QC - Microbiology Manager

21 Aug 2020
18 Sep 2020
Justin Pankinas
Job Type

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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