GxP Bioanalytical Scientist – Clinical Pharmacology

PTC Therapeutics, Inc; Pennington (NJ); On-site; USD 48,000 - 63,000; Full time

Job summary

PTC Therapeutics, Inc. in the United States seeks a Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology to perform quantitative analyses of biological samples in support of clinical and preclinical development of small and large molecule products.

The role covers assay development/validation (LC-MS/MS, qPCR, ELISA/MSD, flow cytometry), regulatory compliance, data interpretation, and cross-functional collaboration to support regulatory submissions.

Qualifications

• Master's or Bachelor's with regulatory bioanalysis experience (clinical/preclinical).
• Experience applying analytical techniques to regulated bioanalysis (LC-MS/MS, qPCR, ELISA, MSD, flow).
• Understanding of FDA or global health authority method validation guidelines.
• Ability to work on complex problems and present data clearly.

Responsibilities

• Perform quantitative analysis of biological samples for clinical/preclinical development.
• Develop/validate bioanalytical assays and conduct regulated bioanalysis.
• Collaborate with cross-functional drug development teams and manage timelines.
• Ensure scientific quality and GLP/GDP compliance; maintain notebooks.
• Present results and timelines at project team meetings.

Skills

LC-MS/MS

qPCR

ELISA

MSD

Flow cytometry

Bioanalytical method validation

Data analysis

MS Excel

MS PowerPoint

Regulatory compliance

Education

Master's degree in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or related

Bachelor's degree in the same disciplines with at least 2 years of regulated bioanalysis experience

Tools

MS Excel

MS PowerPoint

Job description

PTC Therapeutics, Inc. in the United States seeks a Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology to perform quantitative analyses of biological samples in support of clinical and preclinical development of small and large molecule products.

The role covers assay development/validation (LC-MS/MS, qPCR, ELISA/MSD, flow cytometry), regulatory compliance, data interpretation, and cross-functional collaboration to support regulatory submissions.