Group Lead - Analytical Development


Waterloo, IA 50701



Group Leader – Analytical Development – Pharmaceutical / Drug Substances

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.

Job Accountabilities and Responsibilities

  • Safety 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
  • Participate 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

Job Qualifications

  • 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, GC/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
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