Principal Scientist, Analytical Development GMP Methods

Cambrex; Charles City (IA); On-site; USD 140,000 - 190,000; Full time

Job summary

Cambrex in Charles City, IA seeks a Principal Scientist I to provide technical support for multiple project teams. You will develop, validate and transfer analytical methods for APIs, intermediates and raw materials, ensuring strict GMP compliance and robust documentation.

The role requires PhD with extensive experience (or MS/BS with substantial pharma lab background) and ability to lead investigations, coordinate tests, and train staff across Analytical Development and Quality Control.

Qualifications

• Ph.D. or master's/BS with extensive lab pharma experience; transfer to manufacturing preferred.
• Demonstrated understanding of GMP and regulatory requirements in the pharmaceutical industry.
• Experience in developing, validating, and transferring analytical methods for APIs and materials.

Responsibilities

• Develop, establish, and validate analytical testing methodologies for materials and products.
• Lead investigations and collaborate cross-functionally to resolve analytical issues.
• Perform assays using standard analytical methods and document results.
• Train and troubleshoot with analytical instrumentation (HPLC, GC, GC/MS, FTIR).
• Write and review technical reports and SOPs; maintain notebooks and documentation.
• Coordinate external testing and transfer methods to QC and other groups.

Skills

Analytical chemistry

Cross-discipline knowledge

GMP/Regulatory knowledge

Communication

Problem solving

Time management

Leadership

Technical documentation

External influence

Operational excellence

Education

Ph.D. in Chemistry or related field

M.S. in Chemistry or related field

B.S. in Chemistry or related field

Tools

HPLC

GC

GC/MS

FTIR

Titrator

Particle Size Analyzer

Job description

Cambrex in Charles City, IA seeks a Principal Scientist I to provide technical support for multiple project teams. You will develop, validate and transfer analytical methods for APIs, intermediates and raw materials, ensuring strict GMP compliance and robust documentation.

The role requires PhD with extensive experience (or MS/BS with substantial pharma lab background) and ability to lead investigations, coordinate tests, and train staff across Analytical Development and Quality Control.