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Group Leader, Analytical Development

Company: CPS, Inc.
Location: Waterloo
Posted on: February 15, 2021

Job Description:

Group Leader, Analytical Development

Reporting to the Director, Research and Development, the Group Leader of Analytical Development will provide management oversight and leadership to a group of approximately 5 to 8 direct reports with varying levels of degrees and experience. Strict compliance with cGMP guidelines is required to perform most job tasks.

  • Safely and efficiently manage a group of 5-8 direct reports with varying levels of experience and degrees, in order to develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
  • Effectively and professionally communicate project status to internal and external clients during weekly teleconferences and email correspondence
  • Investigate and solve analytical technical issues
  • Assist with or lead efforts to transfer documented analytical methods to QC and PSG departments
  • Provide guidance and/or project leadership for cross-functional project teams
  • Provide guidance to lab personnel on safe lab practices
  • Perform analytical chemistry assays based on new and existing methodologies and qualify reference materials
  • Training staff on analytical techniques and instrumentation
  • Participation in the evaluation of new business opportunities
  • Maintain lab notebooks documenting work and writing technical reports to document analytical methods
  • Maintain compliance with cGMP SOPs and DEA regulations
  • Coordinate off-site testing as necessary
  • If you'd like to hear more about this opportunity and others we are currently working on, please contact Steve Sapita at .

    JO: 264.20SS

    Requirements
    • 4-year degree in Chemistry, with analytical emphasis. Advanced degree preferred
    • At least 5 years of industrial experience in a method development role and validation role with a focus on small scale pharmaceutical method validation
    • Demonstrated success in validating analytical methods to support production in a safe, efficient and economically viable manner
    • Mastery of compliance requirements within cGMP, safety, and regulatory environments required
    • Strong operational knowledge of analytical instrumentation including HPLC, GC, GPC, LC/MS, FTIR, UV-VIS, NMR, and data stations required
    • Experience in pharmaceutical laboratory experience required
    • Familiarity with cGMP regulations required
    • Working knowledge of Empower 2 beneficial
    • Project management experience strongly preferred
    • Windows based computer knowledge
    • Strong leadership skills and multitasking
    • Coordination and problem-solving skills
    • Interpersonal and people skills
    • Planning, organization and project management skills
    • Employee training and development skills
    • Oral and written communication skills
    • If you'd like to hear more about this opportunity and others we are currently working on, please contact Steve Sapita at .

      JO: 264.20SS

Keywords: CPS, Inc., Waterloo , Group Leader, Analytical Development, Other , Waterloo, Iowa

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