• Manager, Microbiology

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1211
    Category
    Quality Control
  • Overview

    The microbiology manager will manage the microbiology team with responsibility for all people aspects, such as coaching, talent development, recruitment and performance management. The successful candidate will provide technical expertise, trouble-shooting and microbiological support to the site. In addition the candidate will liaise with technical subject matter experts from other company sites as well as participate in technical forums.

    Responsibilities

    Responsibilities:

    • Manage a team within the QC Microbiology department involved in the validation, testing and review of raw materials, intermediates (in process) and drug product testing in a cGMP regulatory environment.
    • Responsible for all QC microbiological aspects of cGMP compliance and review of sample analysis.
    • Ensure robust contamination control strategies are developed and implemented.
    • Provide, review and make recommendations for environmental trending and monitoring data for site personnel and management.
    • Support manufacturing personnel and other departments as required in the identification of microbiological root cause analysis and provide technical microbiological support and advice on QC related topics as needed.
    • Demonstrated expertise and knowledge of sterility testing using specialized equipment (e.g. BacT) and diagnostic microbiology. Provide expertise and assistance to troubleshoot and resolve plant / product sterility issues. 
    • Ensure all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
    • Review and approve investigations, SOPs and reports.
    • Oversee laboratory investigations and generate reports in response to invalid assays, Deviations, OOS/OOT
    • Oversee the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate
    • Ensure CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
    • Participate in inspections for regulatory/internal/corporate audits.
    • Present micro data reports clearly and concisely to senior management, including QC performance metrics and trends.
    • Proactively identifies and implements improvements and lean initiatives.
    • Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
    • Contribute to the development of department budget and provide sound financial stewardship, management and control
    • Work closely with the Quality Leadership Team on key operational and strategic areas
    • Ensure compliance with safety, health, environmental and cGMP and other applicable regulations. 

     

     

     

    Preferred Laboratory Experience

    • Microbiology
    • Environmental monitoring
    • Microbial Identification
    • Bioburden
    • Validation studies
    • Familiar with USP methodology

    Qualifications

    Requirements:

    • S. degree in Microbiology or Biotechnology or other relevant scientific discipline with 8+ years industry experience within the pharmaceutical or biotechnology industry along with previous supervisory and/or leadership experience.
    • In depth knowledge of current regulatory requirements in support of cGMP manufacturing operations.
    • Experience in aseptic operations preferred
    • Team player, who is dynamic, motivated and excited to work with a wide range of internal experts and functions.
    • Excellent communications and decision-making skills, leading with initiative and ambition, and a proven ability to deliver excellence.
    • Collaborate and foster internal team work with other cross-functional areas and sites.
    • Has ability to change the thinking of or gain acceptance of others in sensitive situations.
    • Maintains the highest standards of ethical behavior.
    • Results orientated and performance driven.
    • Strong analytical ability and associated problem solving.
    • Experience with regulatory inspections (e.g. FDA)
    • Report, standards, policy writing skills required
    • May be required to work alternate shifts

     

    Working Conditions and Physical Requirements:

    • Ability to sit or stand for extended periods of time 
    • Intermittent walking to gain access to work areas
    • Finger dexterity sufficient to use a computer and to complete paperwork activities
    • Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
    • Hearing sufficient to communicate with individuals by telephone and in person
    • Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
    • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
    • May be required to work alternate shifts
    • Ability to gown aseptically for work in Clean Room environments
    • Job performed in a lab, office, or utility (noisy) environment
    • Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
    • Dendreon is an EEO/AA employer M/F/D/V.

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