Senior Scientist, Analytical Development

PTC Therapeutics seeks a Senior Scientist in Analytical Development to support method development, validation, and implementation for early and late-stage pharmaceutical projects. The role involves cross-functional collaboration with internal teams and external contract organizations to ensure analytical methods meet regulatory standards and support drug submissions.

Responsibilities

• Develop and implement analytical methods for NCEs and drug products using chromatography and related techniques
• Coordinate analytical testing requirements for APIs and drug products; oversee method transfer and validation at CMOs
• Investigate unknown impurities and conduct impurity identification using HPLC, LC/MS, and GC/MS
• Compile analytical data from internal and external sources; author and review regulatory documents for submissions
• Manage laboratory instrumentation procurement, installation, and qualification; coordinate cross-functional analytical activities

Requirements

• Master's degree in Chemistry, Biochemistry, or Pharmacy with 5+ years analytical development experience; or PhD with 4+ years experience
• Extensive hands-on experience developing and validating analytical methods (HPLC, LC/MS, GC/MS, dissolution, particle size)
• Demonstrated proficiency troubleshooting analytical methods and managing laboratory instrumentation
• Working knowledge of US and international CMC regulations, GMP, 21 CFR, and ICH guidelines
• Experience with LIMS and chromatographic data systems; proficiency in Microsoft Office
• Strong communication skills, ability to work independently and collaboratively in fast-paced environments
• Experience designing forced degradation studies and reviewing analytical data at release and stability