Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology

PTC Therapeutics seeks a contractor bioanalytical scientist to perform quantitative analyses of biological samples using techniques such as LC-MS/MS and ELISA in support of clinical and preclinical drug development. The role involves assay development, validation, regulatory compliance, and cross-functional collaboration within a matrixed team environment.

Responsibilities

• Perform quantitative bioanalysis of biological samples including plasma, urine, and cells for regulated studies
• Develop, validate, and qualify bioanalytical assays under FDA and global health authority regulations
• Collaborate with clinical and preclinical development teams to meet project timelines and deliverables
• Ensure scientific quality and regulatory compliance of bioanalytical projects and maintain detailed documentation
• Present results and project updates to development team members and contribute to analytical reports

Requirements

• Master's degree in biology, chemistry, biochemistry, pharmaceutical science, or related discipline
• Bachelor's degree with minimum 2 years regulated bioanalysis experience in clinical or preclinical samples
• Proficiency with LC-MS/MS, qPCR, ELISA, MSD, and flow cytometry analytical techniques
• Knowledge of FDA and global health authority bioanalytical method validation guidelines
• Applied understanding of GLP, GDP, and relevant regulatory requirements
• Strong written and verbal communication skills with Microsoft Office proficiency
• Ability to work independently and collaboratively in fast-paced, multi-disciplinary environments

Compensation: $35 - $46/hour