Reporting to the Director, Analytical 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.

• 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

• 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 3 beneficial
• Project management experience strongly preferred
• Windows based computer knowledge

• 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