Analytical Scientist II - Method Development & QC

Cambrex Corp.; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Cambrex Corp. is a leading global CDMO providing drug substance, drug product, and analytical services. The role focuses on executing analytical methods, release and stability testing, and data interpretation to support regulatory compliance.

Based in Durham, NC, you will work under supervision, collaborate with scientists, and contribute to method development and troubleshooting while maintaining detailed laboratory records and safety practices.

Qualifications

• Working knowledge of experimental design, including chemistry supporting method development.
• Working knowledge of analytical techniques and instrumentation such as NMR, IR, MS and HPLC.
• Able to comply to SOPs and basic regulatory compliance (FDA, cGMP).
• Strong data analysis and technical writing skills.
• Good attention to details and problem-solving abilities.
• Familiarity with computer software and LIMS systems.

Responsibilities

• Execute analytical methods for in-process control, release testing and stability monitoring of bulk drug substances and drug products under cGMP guidelines.
• Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.
• Maintains compliant records with little or no supervision.
• Able to write technical documents with assistance.
• Strong understanding and proficiency in use and maintenance of instrumentation and methodologies.
• Participate in cGMP activities and ensure regulatory compliance.

Education

B.S./

Tools

HPLC

NMR

IR

MS

Empower

ChemDraw

Job description

Cambrex Corp. is a leading global CDMO providing drug substance, drug product, and analytical services. The role focuses on executing analytical methods, release and stability testing, and data interpretation to support regulatory compliance.

Based in Durham, NC, you will work under supervision, collaborate with scientists, and contribute to method development and troubleshooting while maintaining detailed laboratory records and safety practices.