Analytical Development, Group Leader

Cambrex - Charles City; Charles City (IA); On-site; USD 110,000 - 140,000; Full time

Job summary

Cambrex - Charles City seeks a Group Leader of Analytical Development to supervise day-to-day lab activities and provide leadership in development, validation, transfer, and verification of analytical methods on site.

The role emphasizes staff training, career development, project management, customer interaction, and reporting results while ensuring GMP compliance, DEA regulations, and cross-functional collaboration with QC and Process Support teams.

Qualifications

• Supervise a group of 5-8 direct reports in method development and validation.
• Coordinate effective communication of project status via calls and emails.
• Investigate and solve analytical technical issues promptly.
• Lead transfer of methods to QC and Process Support.
• Guide cross-functional project teams and provide leadership.
• Promote safe laboratory practices and GMP compliance.
• Document work in notebooks and write technical reports.

Responsibilities

• Maintain and validate analytical testing methodologies for materials and products.
• Oversee training programs and staff development.
• Assist with off-site testing coordination as needed.
• Support R&D initiatives and connect with dependent departments.

Skills

Leadership

Project management

Team training

Communication

Analytical chemistry

Education

Bachelor's degree in Chemistry

Advanced degree beneficial

Job description

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

• 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

Equal employment opportunity, including veterans and individuals with disabilities.