Job Overview
The Group Leader of Analytical Development will supervise day to day laboratory activities while providing leadership in the development, validation, transfer, and verification of the analytical methods used on site. This supervisory role will be focused on training of staff, career development support, project management, customer interaction, provide management oversight project results reporting, team collaboration, plant support work and bench to analytical technology transfer.
Responsibilities
- Safely and efficiently managing a group of 5-8 direct reports with varying levels of experience and degrees to develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products.
- Effectively and professionally communicating project status to internal and external clients during weekly teleconferences and email correspondence.
- Investigating and solving analytical technical issues.
- Assisting with or leading efforts to transfer documented analytical methods to Quality Control and Process Support departments
- Providing guidance and/or project leadership for cross functional project teams
- Providing guidance to laboratory personnel on safe laboratory practices
- Perform analytical chemistry assays based on new and existing methodologies and qualify reference materials.
- Training staff on analytical techniques and instrumentation
- Participating in the evaluation of new business opportunities
- Maintaining laboratory notebooks documenting work and writing technical reports to document analytical methods
- Maintain compliance with GMP SOPs and DEA regulations
- Coordinate off-site testing as necessary
- Participation in design/execution in R&D initiatives
- Grow/maintain connections with dependent departments
Qualifications/Skills
- 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, 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 3 beneficial
Education, Experience & Licensing Requirements
- 4 year degree in Chemistry, with analytical emphasis. Advanced degree beneficial
- 8 or more years of industrial experience in a method development and validation role with a focus on small scale pharmaceutical method validation
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