Analytical Scientist II: Method Development & QC

Cambrex Corp.; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Cambrex Corp. is seeking a scientist to execute analytical methods for in-process control, release testing, and stability monitoring of drug substances and drug products under cGMP guidelines.

You will design, optimize, and document methods, maintain traceable records, and ensure regulatory compliance while collaborating with cross-functional teams. The role requires strong data interpretation, instrument proficiency (HPLC/GC/NMR), and the ability to communicate results clearly in group

Qualifications

• B.S./B.A. Chemistry with 4+ years of experience in related industry or MS with 0+ years related experience
• Working knowledge of FDA and cGMP regulations
• Ability to write technical documentation and SOPs
• Strong attention to detail and problem-solving skills
• Ability to operate laboratory equipment and present results clearly

Responsibilities

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines
• Participate in experimental design and development of methods and testing requirements
• Maintain compliant records with minimal supervision
• Write technical documents with assistance
• Ensure compliance with cGMP and regulatory guidelines
• Analyze information for technical correctness and communicate results to supervisor
• Maintain laboratory equipment and supplies, and contribute to safety programs

Skills

Analytical testing

cGMP

Data analysis

Team collaboration

Method development

Instrument maintenance

Documentation

Regulatory compliance

SOP adherence

Problem solving

Education

B.S./B.A. Chemistry, 4+ years

Tools

HPLC

GC

NMR

IR

MS

Empower

ChemDraw

Microsoft Word

PowerPoint

Excel

Job description

Cambrex Corp. is seeking a scientist to execute analytical methods for in-process control, release testing, and stability monitoring of drug substances and drug products under cGMP guidelines.

You will design, optimize, and document methods, maintain traceable records, and ensure regulatory compliance while collaborating with cross-functional teams. The role requires strong data interpretation, instrument proficiency (HPLC/GC/NMR), and the ability to communicate results clearly in group