Group Leader, Analytical Development

Cambrex•Charles City, IA

6h•Onsite

About The Position

Cambrex is a leading global contract development and manufacturing organization (CDMO) with over 40 years of experience and a team of over 2,000 professionals. They provide drug substance, drug product, and analytical services across the entire drug lifecycle, serving as a trusted partner in branded and generic markets. Cambrex aims to foster a culture where colleagues engage in meaningful work, learn new skills in a safe environment, and strengthen connections. The company offers a competitive benefits package and career growth opportunities, committed to quality and safety. The Group Leader of Analytical Development will supervise daily laboratory activities, providing leadership in the development, validation, transfer, and verification of on-site analytical methods. This supervisory role includes staff training, career development support, project management, customer interaction, management oversight of project results, team collaboration, plant support, 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.
4 year degree in Chemistry, with analytical emphasis.
8 or more years of industrial experience in a method development and validation role with a focus on small scale pharmaceutical method validation

Nice To Haves

Working knowledge of Empower 3 beneficial
Advanced degree 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