GxP Bioanalytical Scientist for Clinical Pharmacology

PTC Therapeutics, Inc.; Hopewell (NJ); Presencial; USD 48.000 - 63.000; A tiempo parcial

Descripción de la vacante

PTC Therapeutics, Inc. is seeking a Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology to support quantitative analyses of biological samples in development programs. Responsibilities include LC-MS/MS, qPCR, ELISA/MSD, and flow cytometry under GLP/GDP compliance.

You'll coordinate cross-functional studies, interpret data, and present results to project teams, contributing to regulatory submissions and scientific quality in a fast-paced, matrixed environment.

Formación

• Master's degree in biology, chemistry, biochemistry, pharma science, pharmacology or related field, or Bachelor's with 2+ years regulated bioanalysis experience.
• Experience with regulatory bioanalysis of clinical/preclinical samples (plasma, urine, cells).
• Knowledge of FDA or global health authority bioanalytical method validation guidelines.
• Ability to work on complex problems and collaborate in a fast-paced team.

Responsabilidades

• Quantitatively analyze biological samples for small/large molecules in development.
• Develop, validate/qualify bioanalytical assays and conduct regulated bioanalysis.
• Coordinate bioanalytical studies and manage project timelines.
• Ensure scientific quality and comply with GLP and GDP.
• Present results and timelines at project team meetings.

Conocimientos

LC-MS/MS

qPCR

ELISA

MSD

Flow cytometry

Educación

Master's degree in biology/chemistry or related

Bachelor's degree with 2+ years regulated bioanalysis

Herramientas

MS Excel

MS PowerPoint

Descripción del empleo

PTC Therapeutics, Inc. is seeking a Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology to support quantitative analyses of biological samples in development programs. Responsibilities include LC-MS/MS, qPCR, ELISA/MSD, and flow cytometry under GLP/GDP compliance.

You'll coordinate cross-functional studies, interpret data, and present results to project teams, contributing to regulatory submissions and scientific quality in a fast-paced, matrixed environment.