• Manager, Bioassay

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1210
    Category
    Quality Control
  • Overview

    The Manager, Bioassay is responsible for the oversight, planning, coordination, and supervision of technical and operational activities in the Bioassay laboratory. 

    Responsibilities

    Responsibilities:

    • Manage bioassay operations related to planning and management of laboratory control systems and QC programs, resource management and vendor management.
    • Oversee execution of testing including routine analysis and raw material testing.
    • Well versed in various analytical techniques such as Flow Cytometry, ELISAs, and cell bioassays and other applicable methods to the testing of biopharmaceuticals.
    • Provide guidance during validation and technology transfer of analytical methodologies and stability programs.
    • Review and approve standards, methods and procedures for inspecting, testing and evaluating the quality of company products.
    • Evaluate and determine corrective actions to be taken to ensure conformity with quality specifications.
    • Ensure finished products conform to company standards and satisfy GMP regulations.
    • Ensure adherence to department, site and corporate SOPs and other regulatory requirements.
    • Accountable for the management of Laboratory Investigation Reports (LIR) and data trending.
    • Interact with agents from regulatory agencies and participate in regulatory inspections.
    • Select, develop and evaluate personnel to ensure functional objectives are met.
    • Provide technical insight to other departments as part of cross-functional project teams.
    • Contribute to the development of the department budget and monitor expenditures.

    Scope:

    • Establishes operational objectives and assignments and delegates assignments to direct report managers. Objectives are reviewed to determine success of operation. 
    • Involved in developing, modifying and executing company policies that affect immediate operations and may also have company-wide effect.
    • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
    • Develops and ensures budgets, schedules and performance requirements are met.
    • Erroneous decisions will result in critical delays in schedules and/or unit operations and may jeopardize overall business activities.
    • Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.

    Qualifications

    Job Requirements:

    • Bachelor’s degree in a scientific discipline.
    • Typically 10+ years related progressive experience in cGMP/FDA regulated industry, and a minimum of 5 years supervisory experience is preferred.
    • Strong knowledge of basic lab testing techniques, preferably in Immunology.
    • Experience in conducting laboratory investigation, writing nonconformance, implementing CAPAs and initiating change controls.
    • Familiarity with technology transfer and building a quality infrastructure to support commercialization. Experience with validating analytical methods and processes related to instrument and laboratory management systems 
    • Strong level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys)
    • High attention to detail, quality and compliance with strict adherence to test procedures and protocols
    • Ability to learn new technologies and processes quickly and to understand the technical concepts behind each assay performed.
    • Strong experience in applying GMP in QC lab in conformance to US/ROW standards.
    • Knowledge of cGMP/QSR/ICH and FDA device/drug/biologics regulations preferred.
    • Proficient in MS Office applications.
    • Ability to effectively negotiate and build collaboration amongst individuals.
    • Demonstrated ability to develop, coach, and mentor key employees.
    • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
    • Comfortable ina fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.

     

     

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