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