Analytical Development Lead Scientist – GMP Method Transfer

Cambrex Corp.; Charles City (IA); On-site; USD 120,000 - 160,000; Full time

Job summary

Cambrex Corporation seeks a Principal Scientist I to provide analytical development support for API substances and intermediates. The role involves method development, transfer to QC, and ensuring GMP compliance across multiple project teams.

Responsibilities include validating analytical methods, instrument troubleshooting, and writing technical documentation. Strong leadership, communication, and cross‑functional collaboration are essential in this fast‑paced, quality‑driven environment.

Qualifications

• Ph.D. in Chemistry or related field with minimum 8 years of experience.
• MS with 10+ years of experience in lab/pharma environment.
• B.S. with 12+ years of experience; pharma experience preferred.
• Transfer processes to commercial scale manufacturing.
• Excellent verbal and written communication/interpersonal skills.

Responsibilities

• Safely develop, establish, and validate analytical testing methodologies for raw materials, intermediates, and final products.
• Participate in teams to investigate analytical issues within Analytical Development, Chemical Development, Process Support Group and Quality Control.
• Perform analytical chemistry assays based on new and existing methodologies.
• Operate analytical instruments such as HPLC, GC, GC/MS, FTIR, Titrator, Particle Size Analyzer.
• Write technical reports documenting analytical methods and maintain lab notebooks.
• Maintain GMP SOP compliance and DEA regulations; transfer methods to QC and Process Support.
• Coordinate off-site testing and qualify reference materials.
• Lead investigations and drive problem solving within projects as needed.

Skills

Analytical Chemistry Knowledge

Cross Discipline Knowledge

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 or related field

M.S. in Chemistry or related field

B.S. in Chemistry or related field

Tools

HPLC

GC

MS

FTIR

Titrator

Particle Size Analyzer

Job description

Cambrex Corporation seeks a Principal Scientist I to provide analytical development support for API substances and intermediates. The role involves method development, transfer to QC, and ensuring GMP compliance across multiple project teams.

Responsibilities include validating analytical methods, instrument troubleshooting, and writing technical documentation. Strong leadership, communication, and cross‑functional collaboration are essential in this fast‑paced, quality‑driven environment.