Analytical Scientist I – GMP & Lab Data

Cambrex Corp.; Durham (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Cambrex Corporation seeks a highly motivated analyst to execute analytical methods and provide support for release and stability testing of drug substances and drug products. You will organize routine work under supervision and interpret data within cGMP guidelines.

Responsibilities include method setup, data analysis, documentation in LIMS, and contributing to SOPs and CAPAs while maintaining safety and quality in a fast-paced environment.

Qualifications

• Experience with analytical method development support.
• Familiar with FDA and cGMP regulations.
• Ability to work under supervision and in team.
• Proficient in analytical instruments (HPLC, GC, etc.).
• Capable of documenting data and results accurately.
• Strong written and verbal communication.

Responsibilities

• Execute analytical methods for in-process control, release testing, and stability.
• Maintain knowledge of instrumentation and techniques.
• Prepare and review development reports.
• Ensure compliance with cGMP and regulatory guidelines.
• Communicate results to supervisor.
• Maintain lab notebook and LIMS records.

Skills

HPLC

GC

NMR

IR

MS

Empower

ChemDraw

Microsoft Word

PowerPoint

Excel

Problem-solving

Attention to detail

Education

B.S./B.A. Chemistry

Tools

LIMS

Empower

ChemDraw

Microsoft Word

PowerPoint

Excel

Job description

Cambrex Corporation seeks a highly motivated analyst to execute analytical methods and provide support for release and stability testing of drug substances and drug products. You will organize routine work under supervision and interpret data within cGMP guidelines.

Responsibilities include method setup, data analysis, documentation in LIMS, and contributing to SOPs and CAPAs while maintaining safety and quality in a fast-paced environment.