Analytical Development Scientist III — Method Validation

Cambrex Corp.; Charles City (IA); On-site; USD 85,000 - 110,000; Full time

Job summary

Cambrex Corp. is seeking a Senior Scientist III to provide analytical support across project teams, developing, validating, and transferring methods for APIs, intermediates, and raw materials in a cGMP environment.

The role emphasizes analytical chemistry expertise, instrumentation proficiency, and collaboration with Development and Quality groups to ensure regulatory compliance and robust data generation.

Qualifications

• Ph.D./MS/BS with extensive lab experience in pharmaceutical analytics and cGMP is required.
• Experience applying analytical methods to APIs, intermediates, and raw materials under GMP.
• Strong documentation and cross-functional collaboration skills are essential.

Responsibilities

• Safely develop and validate analysis methods for raw materials, intermediates, and APIs.
• Investigate analytical issues with teams across Analytical Development, Chemical Development, and QC.
• Perform assays using established analytical techniques and write technical reports.
• Transfer validated methods to QC and Process Support groups.
• Coordinate off-site testing and ensure regulatory compliance of SOPs.
• Lead local initiatives and mentor junior scientists.

Skills

Analytical Chemistry

Cross Discipline Knowledge

GMP/Regulatory Knowledge

Instrumentation

Communication

Problem Solving

Time Management

Leadership

Technical Documentation

External Influence

Industry Credibility

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 Corp. is seeking a Senior Scientist III to provide analytical support across project teams, developing, validating, and transferring methods for APIs, intermediates, and raw materials in a cGMP environment.

The role emphasizes analytical chemistry expertise, instrumentation proficiency, and collaboration with Development and Quality groups to ensure regulatory compliance and robust data generation.