• Sr. Manager Microbiology

    Job Location US-NY-Melville
    ID
    2018-4124
    # of Openings
    1
    Category
    Manufacturing
    Type
    Direct Hire
  • Overview

    Primary responsibilities will be to support, plan, manage, and execute the daily, short term and long term activities, and goals associated with microbiology lab, environmental monitoring, and product testing programs within the Quality Operations team to support the manufacturing of biologic products.

    Responsibilities

    Responsible for the strategy and direction of the Quality Control Microbiology group which includes product testing, environmental monitoring, clean room management and associated activities. This position manages department team members, including hiring and personnel management of department employees. The incumbent provides leadership and structure to the planning and strategic direction of the day to day and long term work activities. The position will focus on compliance utilizing practical, flexible, and lean laboratory concepts and implement these concepts into the daily operation and functions of the department. Out of the box thinking is a requirement for approaching compliance, regulatory, quality, and operational challenges. Departmental responsibilities include appraising performance, employee management, and departmental related activities such as task definition, laboratory management, and personnel organization. The incumbent provides strategic leadership, participates in compliance directives, coaches and supports laboratory staff in day to day activities. The organization is managed with a view to combining lean lab concepts with effective and compliant procedures and processes for meeting the regulatory requirements. Supports 3 shift manufacturing schedules with available resources, demonstrating creativity and flexibility, in order to provide appropriate presence and availability of staff as needed.

     

    Main Responsibilities:

    • Provide leadership and guidance to day to day operations of QC Microbiology group
    • Manage staff, perform human resource activities such as hiring, performance management and reviews
    • Assures laboratory is organized in a manner to effectively meet test schedules, setting priorities, assuring adequate coverage is provided for off-shift and weekend activities
    • Provide appropriate coaching and development opportunities for laboratory staff members, encouraging out of box participation across and beyond job descriptions and assigned routine activities.
    • Coaches and leads the microbiology team in best practices, risk management of requirements, and organizational tools.
    • Builds partnerships and assures communication with colleagues and peers across departments
    • Responsible for approving or rejecting all drug product related procedures or specifications.
    • Support internal and external audits as the microbiology, sterilization, endotoxin bioburden, and environmental monitoring and inspection subject matter expert.
    • Support regulatory submissions
    • Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks that maintain an effective operation to support business needs.
    • Contribute as SME to development, review, approval and execution of various qualification/validation initiatives
    • Develop laboratory expense and personnel tools for determining near and long term resource and materials requirements for budgeting and project management purposes
    • Assures laboratory data and reports are prepared and presented in a meaningful, timely, and logical manner.
    • Assures consistency with practices within the Quality Control Chemistry and Microbiology laboratories.
    • Assure appropriate knowledge management and cross training occurs within the group, assuring continuity to testing and facility support
    • Assure appropriate training matrices are sustained to assure laboratory readiness
    • Assist and take ownership for development, initiation, authorship, and closure of change controls, CAPAs and deviations- even across departmental boundaries
    • Responsible for ensuring laboratory operations are in compliance with current USP/Annex 1/ISO
    • Assure appropriate procedures are applied regarding all phases of EM and microbiology laboratory operations

    Qualifications

    • Develop laboratory expense and personnel tools for determining near and long term resource and materials requirements for budgeting and project management purposes
    • Assures laboratory data and reports are prepared and presented in a meaningful, timely, and logical manner.
    • Assures consistency with practices within the Quality Control Chemistry and Microbiology laboratories.
    • Assure appropriate knowledge management and cross training occurs within the group, assuring continuity to testing and facility support
    • Assure appropriate training matrices are sustained to assure laboratory readiness
    • Assist and take ownership for development, initiation, authorship, and closure of change controls, CAPAs and deviations- even across departmental boundaries
    • Responsible for ensuring laboratory operations are in compliance with current USP/Annex 1/ISO
    • Assure appropriate procedures are applied regarding all phases of EM and microbiology laboratory operations

     

    #CB

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed