Manager of Microbiology

Overview

The Manager of Quality Control (QC) - Microbiology is responsible for overseeing the Quality Control strategies and operations, including testing functions in support of the development and testing services of Phase I-III and Commercial Microbiological testing and Environmental Monitoring functions. The QC Microbiology Manager ensures compliance with GMP and company specifications as well as relevant pharmacopeia compendia. The Manager identifies areas for continuous improvement and/or implementation of industry best practices and drives implementation in the laboratory.

The Manager keeps the Head of Quality informed of all departmental activities and product-related events.

• Provides technical supervision and leadership of teams assigned to perform environmental monitoring, product release testing, routine, and non-routine microbiological testing.
• Collaborates with other departments to provide microbiology expertise and support for smooth running of GMP manufacturing operations.
• Oversees and maintains the quality control microbiological testing program (including sterility, bioburden, identifications, Environmental Monitoring, and outsourced test laboratories).
• Participates in and carries out continuous quality improvements in the QC laboratory.
• Identifies and resolves internal quality control microbiological testing issues.
• Ensures compliance with cGMP and safety requirements within the QC microbiological laboratory.
• Schedules and provides technical oversight of microbiological testing performed internally and externally sourced to support GMP manufacturing and pre-clinical activities and studies.
• Participates in project-specific, system, client, and vendor audits.
• Participates in internal audits of GMP QC data and records, monitoring files and study files. Reviews new and executed documents for compliance with stated SOPs, formats, and regulatory requirements (especially protocols, deviations, investigations, amendments, etc.).
• Writes and/or reviews SOPs pertaining to Quality Control microbiological operations, STM’s (standard test methods), and qualification and stability protocols (if needed) to insure appropriate codification of GMP procedures.
• Ensures QC microbiological laboratories and facilities are always in an audit-ready status.
• Serves as a back-up to QC client representative in meetings for microbiological matters.
• Acts as technical QC microbiological SME in support of client needs and projects and during third-party inspections/audits.
• Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
• Engages actively with Project Management and other department functions to ensure GMP programs are properly supported to achieve expectations; maintains effective and professional communication between all parties, including the customer.
• Identifies, maintains, and reports functional KPIs to site management.
• Performs other duties as assigned.

• Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Preferred 15+ years relevant work experience in Quality Control laboratories.
• Preferred three to five (10-15) years of leadership/ supervisory/management experience in commercial laboratory operations.
• 10 years of applied Microbiology experience in a commercial pharmaceutical, GMP manufacturing environment (preferably parenteral and in a CMO/CDMO/Clinical Environment).
• Experience in Analytical or Microbiological testing including Environmental Monitoring.
• Auditing and compliance experience in a biopharmaceutical or clinical research organization and/or federal regulatory experience is strongly preferred.
• Experience in a GMP environment to include ICH guidelines, FDA guidelines, USP and EP, and other applicable regulatory guidance (US and EU).
• Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff and management across functional groups and levels.
• Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrates the ability to analyze data and information and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrates knowledge and experience with electronic Quality Management Systems such as Master Control and Track Wise.
• Demonstrates solid understanding of current federal, local, and international regulations regarding production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrates familiarity with Microsoft Office programs (Word, Excel, PowerPoint, Project, Teams, Outlook, etc.).
• Demonstrates the ability to…