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Associate Director, Quality Control

Company: EPM Scientific
Location: Framingham
Posted on: August 4, 2022

Job Description:

Job Title : Associate Director, Quality ControlSummary : Are you someone who is passionate about having a hand in changing the lives of patients across the globe? My client is working with a novel class of cancer therapeutics to target a variety of difficult to treat cancers including Lung Cancer, Melanoma, Solid Tumors and MSI-high tumors. The unique dual mechanism action of these Oncolytic Immunotherapies are designed to combine and enhance the effectiveness of several different modalities including immunotherapy, chemotherapy, radiation and small molecules. My client is looking for someone who is seeking an opportunity to support a brand new lab and build out a team of their own. This is a great opportunity for any seasoned professionals in the QC Microbiology space.The Associate Director, Quality Control will be responsible for :

  • Setting up and maintaining the QC Microbiology and Analytical laboratories and systems.
  • Establishing and overseeing the environmental, water and gas monitoring program, including environmental qualification of clean room suites and aseptic fill finish (Grade A/B).
  • Continue to develop the EM program with regulatory requirements and develop robust procedures to monitor and identify any trends.
  • Over seeing the day-today operations of the QC Microbiology laboratories including sample management, equipment maintenance and calibration, testing schedules and identification/isolation of detected microbes.
  • Establishing and maintaining procedures for QC testing, including writing and reviewing SOPs, protocols and reports.
  • Ensuring that all analytical and microbiological methods are qualified/validated appropriately.The Associate Director, Quality Control should have the following requirements :
    • Bachelor's Degree in Chemistry, Biochemistry, Microbiology or a related science.
    • At least 10 years in a GMP/GLP laboratory experience in a Microbiology testing capacity and at least 3 years of management experience in a GMP-regulated environment.
    • Excellent analytical skills and technical experience, preferably with setting up a testing laboratory and/or supporting a manufacturing facility.
    • Excellent organizational and communication skills.If this sounds like something you would be interested in, please apply!

Keywords: EPM Scientific, Framingham , Associate Director, Quality Control, Executive , Framingham, Massachusetts

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