Senior Analytical Development Scientist II – GMP Method Expert

Cambrex Corp.; Charles City (IA); On-site; USD 90,000 - 120,000; Full time

Job summary

Cambrex Corp. is seeking a Senior Scientist II to provide technical support across project teams, evaluating analytical results and developing/validating methods for APIs and intermediates in a GMP setting.

The role requires strong analytical chemistry knowledge, experience with instruments like HPLC and GC, and ability to write technical documentation while maintaining strict regulatory compliance.

Qualifications

• Ph.D. in Chemistry or related field with minimum 2 years of experience or M.S. in Chemistry or related field with minimum 6 years of experience or B.S. in Chemistry with 10 years in lab environment.
• Excellent verbal and written communication/interpersonal skills, organizational skills, and ability to work in a diverse team environment.

Responsibilities

• Safely develop, establish, and validate analytical testing methodologies for materials and final products.
• Participate in teams to investigate analytical issues within Analytical Development, Chemical Development, Process Support and Quality Control.
• Perform analytical chemistry assays using new or existing methods.
• Operate analytical instrumentation (HPLC, GC, FTIR, Titrator, P3D or similar) and support method transfers.
• Write technical reports documenting analytical methods and maintain lab notebooks.
• Ensure GMP SOPs and DEA regulations are followed.
• Transfer analytical methods to QC and Process Support groups.
• Set up new/existing methods for compound ID, purity, potency testing.
• Coordinate off-site testing as needed.
• Conduct testing for Chemical Development as required.
• Qualify reference materials and support OE initiatives.
• May perform other duties as required.

Skills

Analytical Chemistry

Cross Discipline

GMP/Regulatory Knowledge

Instrumentation

Communication

Problem Solving

Time Management

Leadership

Technical Documentation

External Influence

Industry Credibility

Operational Excellence

Change Orientation

Education

Ph.D. in Chemistry

M.S. in Chemistry

B.S. in Chemistry

Tools

HPLC

GC

FTIR

Titrator

Particle Size Analyzer

Mass Spectrometry (MS)

Job description

Cambrex Corp. is seeking a Senior Scientist II to provide technical support across project teams, evaluating analytical results and developing/validating methods for APIs and intermediates in a GMP setting.

The role requires strong analytical chemistry knowledge, experience with instruments like HPLC and GC, and ability to write technical documentation while maintaining strict regulatory compliance.