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Senior Manager, QC Microbiology

Workforce Genetics

Senior Manager, QC Microbiology

Baltimore, MD
Full Time
Paid
  • Responsibilities

    Are you looking for a job with a mission oriented biotech where you can have a real impact at work and in the world? We're hiring for a Senior Manager, QC Microbiology to support the development of vaccines for COVID-19 and other infectious diseases

    Overview

    Responsible for managing and oversight of routine and non-routine microbiological activities. This includes scheduling and execution of the environmental monitoring testing program, utility testing program, raw material, in-process, and product release testing requirements and well as ensuring adequate resources to support non-routine method qualification, area re-qualification, growth promotion, and reagent control activities. The manager will provide support in transferring new microbiological projects into the Bayview site and maintain routine analysis and release of product. The manager will serve in supporting other sites as needed and support documentation required to conduct laboratory and data services in a complaint manner.

    Responsibilities 

    • Manages the Microbiology laboratory support of production by ensuring the timely release of manufacturing areas, utilities, raw materials, in-process, and finished products
    • Serves as the technical subject matter expert on microbiological assays and techniques
    • Defines and manages the activities of the Microbiology Laboratory to assure that all test samples meet the raw materials, intermediate, final product, and stability specifications
    • Provides expertise and troubleshoots microbiology related issues
    • Authors, reviews, and approves SOPs, validation protocols, investigations, and batch records specifications as they relate to this department
    • Work with the Microbiology staff to author Microbiology related deviations, CAPA, OOS, and OOL investigations
    • Responsible for cGMP compliance of the laboratory and personnel
    • Define the development needs in the Microbiology Laboratory
    • Represent microbiology in meetings with Production, Quality Assurance, Engineering, Regulatory Affairs, and other related departments
    • Provide industrial microbiology regulatory/technical guidance to site
    • Advises, recommends, and implements resolutions for quality problems and regulatory commitments to site management
    • Interact with other departments as required to define and/or verify the scope of work for a project; i.e. Provide testing services for validation work
    • Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force. Recommends promotions and salary increases as deemed necessary
    • Ensure the completion of projects within budget limits and time projections
    • Participate in and attend professional seminars, conferences, and conventions

    Education and Experience 

    • Bachelor’s Degree in Microbiology/Biology or related field
    • Minimum of 10 years of experience, including 5 or more years of supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, validation, and manufacturing processes
    • Must have previous hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, Enhancement and Inhibition, LAL, Sterility, and Bioburden Testing
    • Competent in the use of various computer programs of Microsoft Access and Excel
    • Excellent communication, documentation, and organization skills
    • In depth knowledge of FDA regulations pertaining to cGMPs, international regulations, and industry practices
    • Experience performing extensive investigations related to microbiology/biology issues