Senior Scientist - Quality Control

Senior Scientist in Quality Control at Thermo Fisher Scientific's Boston location, supporting pharmaceutical and biopharmaceutical drug development. The role involves performing analytical testing, maintaining GMP compliance, and contributing to method validation and continuous improvement initiatives in a laboratory setting.

Responsibilities

• Perform in-process, release, and stability testing independently following established SOPs
• Maintain accurate testing records and ensure cGMP/GDP compliance
• Participate in method validations, transfers, and troubleshooting of analytical methods
• Report out-of-trend and out-of-specification results to management
• Author and review analytical data, SOPs, protocols, and compliance documentation

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biology, or related life sciences
• 4+ years GMP pharmaceutical or biopharmaceutical industry experience (or 2+ years with Master's degree, or PhD)
• Knowledge of chromatography, dissolution, and Karl Fischer techniques
• Experience with analytical equipment: HPLC, GC, KF, dissolution, TOC, UV, IR, pH meter
• Strong understanding of cGMP concepts and regulatory practices
• Excellent attention to detail and written/oral communication skills
• Legally authorized to work in US without sponsorship