GxP Bioanalytical Scientist — Clinical Pharmacology

PTC Therapeutics, Inc.

Pennington (NJ)

On-site

USD 48,000 - 63,000

Full time

2 days ago

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Job summary

PTC Therapeutics, Inc. is seeking a Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology to perform quantitative bioanalyses supporting clinical and preclinical development of small and large molecules.

You will work with LC-MS/MS, qPCR, ELISA/MSD and flow cytometry to generate data for regulatory submissions. The role involves coordinating bioanalytical studies, ensuring project timelines, and maintaining GLP/GDP compliance in a fast-paced team environment.

Qualifications

Master’s or Bachelor’s with relevant bioscience degree and regulated bioanalysis experience.
Experience applying LC-MS/MS, qPCR, ELISA/MSD and flow cytometry to bioanalysis.
Knowledge of FDA bioanalytical method validation guidelines.

Responsibilities

With guidance, performs quantitative analysis of biological samples in clinical/preclinical development.
Develops, validates/qualifies bioanalytical assays and conducts regulated bioanalysis.
Collaborates with development teams and manages bioanalytical project timelines.
Ensures scientific quality of bioanalytical projects.
Adheres to safety and regulatory guidelines.
Supports writing analytical reports.
Complies with GLP and GDP.
Maintains a detailed laboratory notebook.
Represents bioanalysis on project teams and presents results.
Performs other tasks as needed by management.