Senior Analytical Scientist - GMP Method Development & Transfer

Germer International - Pharmaceutical Recruiting; Waterloo (IA); On-site; USD 120,000 - 170,000; Full time

Job summary

Germer International - Pharmaceutical Recruiting is seeking a Principal Scientist to lead analytical method development, validation, and transfer for APIs, intermediates, and raw materials. The role focuses on evaluating results and ensuring compliance in a highly technical environment.

The candidate will develop testing methodologies, interpret data, and document methods while coordinating with QA and Production.

Qualifications

• Ph.D. in Chemistry or related field with minimum 6 years of lab experience.
• M.S. in Chemistry or related field with minimum 10 years of lab experience.
• B.S. degree in Chemistry or related field with 14 years of lab experience.

Responsibilities

• Develop, establish, and validate analytical testing methodologies for raw materials, intermediates, and final products.
• Investigate and resolve analytical technical issues within Analytical Development and Quality Control teams.
• Perform analytical chemistry assays based on new and existing methodologies.
• Operate analytical instruments such as HPLC, GC, GC/MS, FTIR, and titration equipment.
• Write technical reports documenting analytical methods and maintain lab notebooks.
• Ensure compliance with GMP SOPs and relevant regulations (DEA).
• Transfer validated methods to QC and Process Support Group departments.
• Set up new or existing analytical methods for identity, purity, and potency testing.
• Coordinate off-site testing as needed and support Chemical Development.

Skills

Analytical chemistry

Method development

Data interpretation

Team collaboration

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

Germer International - Pharmaceutical Recruiting is seeking a Principal Scientist to lead analytical method development, validation, and transfer for APIs, intermediates, and raw materials. The role focuses on evaluating results and ensuring compliance in a highly technical environment.

The candidate will develop testing methodologies, interpret data, and document methods while coordinating with QA and Production.