Senior Analytical Scientist II: Method Development & Leadership

Cambrex Corp.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Cambrex Corp. in Durham, NC seeks an experienced Analytical Scientist to execute analytical methods and support release and stability testing of drug substances and products.

The role requires independent organization, data interpretation, and strong understanding of method development and validation. You will interact with clients, design experiments, maintain compliant records, write technical documents, and contribute to cGMP compliance.

Qualifications

• Experience designing and executing analytical methods and method development.
• Strong knowledge of cGMP and regulatory requirements.
• Hands-on with HPLC, GC and related analytical techniques.
• Ability to read compendial methodologies and SOPs.
• Familiarity with laboratory data systems and documentation.

Responsibilities

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
• Independently develop and evaluate methodologies; design and implement experiments.
• Participate in experimental design and testing requirements to demonstrate method suitability.
• Maintain compliant laboratory records with minimal supervision.
• Write technical documents with assistance and communicate results to supervision.
• Operate and maintain instrumentation and software for analytical work.
• Mentor and train other team members; lead small projects as needed.

Skills

Experimental design

Advanced laboratory techniques

Cross-functional chemistry

Analytical instruments

SOPs & regulatory

Team training

Data interpretation

HPLC / GC

Education

BS/BA Chemistry with 8+ years

MS Chemistry with 4+ years

PhD with 0+ years

Tools

Empower

ChemDraw

Microsoft Word

PowerPoint

Excel

Job description

Cambrex Corp. in Durham, NC seeks an experienced Analytical Scientist to execute analytical methods and support release and stability testing of drug substances and products.

The role requires independent organization, data interpretation, and strong understanding of method development and validation. You will interact with clients, design experiments, maintain compliant records, write technical documents, and contribute to cGMP compliance.