Senior Analytical Scientist – Method Development & Validation

Cambrex Corp.; Few (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare

Life Insurance

Retirement Planning

Job summary

Cambrex is seeking an experienced analytical scientist to execute methods for in-process control, release testing, and stability monitoring of drug substances and products. You will independently develop methodologies, design experiments, and maintain compliant records with minimal supervision while communicating results to clients and senior staff.

The role requires strong knowledge of analytical techniques, FDA/cGMP regulations, and hands-on laboratory skills.

Qualifications

• Degree in chemistry with advanced experience in drug substance/product analysis.
• Experience designing and qualifying analytical methods and supporting cGMP projects.
• Familiarity with FDA/regulatory expectations and quality systems.

Responsibilities

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products.
• Independently develop and evaluate methodologies, design and implement experiments.
• Participate in experimental design and testing requirements to demonstrate method suitability.
• Maintain compliant records with little or no supervision.
• Write technical documents with assistance.
• Train and mentor junior staff as needed.

Skills

Experimental design

Analytical techniques

FDA & cGMP knowledge

Attention to detail

Team collaboration

Education

B.S./B.A. Chemistry with 8+ years OR M.S. with 4+ years OR PhD with 0+ years experience

Tools

Empower

ChemDraw

Microsoft Word

PowerPoint

Excel

Job description

Cambrex is seeking an experienced analytical scientist to execute methods for in-process control, release testing, and stability monitoring of drug substances and products. You will independently develop methodologies, design experiments, and maintain compliant records with minimal supervision while communicating results to clients and senior staff.

The role requires strong knowledge of analytical techniques, FDA/cGMP regulations, and hands-on laboratory skills.