Analytical Development, Group Leader

Cambrex•Charles City, IA

10d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Working knowledge of Empower 3 beneficial

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