Cambrex
Group Leader, Analytical Development
US-IA-Charles City
Job ID: 2024-3688
Type: Regular Full-Time
# of Openings: 1
Category: Analytical Development
Cambrex - Charles City
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
- 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
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
PI239476899
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