Principal Scientist - ARD

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!

Principal Scientist 1 – ARD will independently conduct development and optimization for methods that have no starting point for intermediates and final products. Develop and optimize robust analytical methods for final product that are validatable. Maintain laboratory notebook and perform data review. Maintain lab instrumentation. Conduct method development and optimization on LC/MS and/or GC/MS. Troubleshoot instrument issues. Work with Process Chemistry department to support analytical needs for process development and manufacturing.

Ensure compliance with applicable Company SOPs and regulatory guidances. Perform laboratory investigations and non‑routine project work including QC issues. Author analytical procedures, protocols, and reports. Act as Analytical lead for internal projects including responsibility for all Analytical aspects of the project from development through technical support of QC for final product release.

With minimal support, understand regulatory requirements and recommend Analytical approaches to clients and CHP colleagues.

With some support, lead larger‑scope projects including cross‑site projects within Cambrex.

• Develop and optimize analytical methods for intermediates and final product.
• Maintain and review notebook and data entries.
• Write analytical procedures, protocols, reports and similar documents.
• Review and revise SOPs.
• Perform laboratory investigations.
• Lead laboratory investigations for Analytical and QC.
• With support lead larger‑scope projects.
• Train and mentor laboratory colleagues.
• Maintain equipment.
• This position works with and handles hazardous materials and wastes. Responsible for recognizing emergency situations concerning hazardous materials and wastes.

Analytical Chemistry Knowledge: Beginning to demonstrate an understanding of advanced theories in Analytical Chemistry and method development.

Cross‑Discipline Knowledge: Higher level of 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; some ability to provide feedback to clients re: clinical strategy.

Instrumentation: Advanced knowledge of HPLC, GC, MS, and ability to train and troubleshoot problems with equipment (and help others).

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…