- 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
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Group Leader, Analytical Development - Charles City, United States - Cambrex
Description
Overview:
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.
Responsibilities:
