Analytical Development Senior Scientist III; Minneapolis, MN TALENT Pipeline

Company Information

You Matter to Cambrex.

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid‑phase peptide synthesis, solid‑state science, material characterization, and highly potent APIs.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast‑paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer‑focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

The Senior Scientist III will provide technical support for multiple project teams. This individual will evaluate and interpret analytical results, develop, validate and transfer analytical methods for APIs, API intermediates and raw materials. Strict compliance with cGMP guidelines is required to perform most job tasks.

• Safely and effectively develop, establish, and validate analytical testing methodologies used to control raw materials, production intermediates, and final products
• Actively participate in teams assembled to investigate and solve analytical technical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control
• Perform analytical chemistry assays based on new and existing methodologies
• Operate analytical instrumentation such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer
• Write technical reports to document analytical methods
• Maintain laboratory notebooks documenting work
• Maintain compliance with GMP SOPs and DEA regulations
• Transfer documented analytical methods to the QC and Process Support Group departments
• Set up new or existing analytical methods for compound identification, purity and potency testing
• Coordinate off‑site testing as necessary
• Conduct testing of analytical samples for the Chemical Development Department as needed
• Qualify reference materials
• May also perform other duties as required

Analytical Chemistry Knowledge: Strong understanding of the fundamentals of Analytical Chemistry.

Cross Discipline Knowledge: Good understanding of the principles of cross‑functional departments, including organic chemistry and engineering.

GMP/Regulatory Knowledge: Demonstrated understanding of industrial GMP and practical application to Cambrex programs;
Ability to help identify risks for regulatory compliance of violation of site SOP.

Instrumentation: Demonstrated ability to use, train, investigate root cause issues with HPLC, GC, good understanding of MS.

Communication: Good written and oral communication skills, ability to communicate with clients without manager supervision.

Problem Solving: Strong demonstration of problem solving, ability to lead investigations.

Time Management: Able to maintain timeline of key activities and use time efficiently; ability to handle projects without supervision though requires regular check in with manager.

Leadership: Regularly seeks to share ideas and learning across the group/site; pushes new initiatives from the ground up.

Technical Documentation and Review: Ability to author and review key technical…