GxP Bioanalytical Scientist, Clinical Pharmacology

ptcbio; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

PTC Therapeutics seeks a Contractor, GxP Bioanalytical Scientist in Clinical Pharmacology to perform quantitative analyses of biological samples (LC-MS/MS, qPCR, ELISA, MSD, flow cytometry) in support of clinical/preclinical development and regulatory submissions.

You will collaborate across development teams, develop and qualify bioanalytical assays, manage project timelines, ensure GLP/GDP compliance, and document results in analytical reports.

Qualifications

• Master's degree or Bachelor's with 2+ years in regulated bioanalysis of clinical/preclinical samples.
• Experience with LC-MS/MS, qPCR, ELISA, MSD and flow cytometry.
• Knowledge of GLP/GDP and analytical report writing (preferred).

Responsibilities

• Perform quantitative analysis of biological samples for small and large molecules in clinical/preclinical development.
• Develop, validate/qualify bioanalytical assays and conduct regulated bioanalysis.
• Collaborate with clinical/preclinical drug development teams.
• Manage and ensure bioanalytical project timelines.
• Ensure scientific quality of bioanalytical projects and compliance.
• Adhere to GLP and GDP; maintain detailed laboratory notebook.
• Assist in writing analytical reports.
• Present results and timelines at project team meetings.
• Support regulatory submissions as needed.

Skills

LC-MS/MS

qPCR

ELISA

MSD

Flow cytometry

Bioanalytical method validation

Regulatory knowledge

Data interpretation

MS Office

Communication skills

Education

Master's degree in biology/chemistry/biochemistry/pharmaceutical science/pharmacology

Bachelor's degree in related discipline + 2+ years regulated bioanalysis experience

Job description

PTC Therapeutics seeks a Contractor, GxP Bioanalytical Scientist in Clinical Pharmacology to perform quantitative analyses of biological samples (LC-MS/MS, qPCR, ELISA, MSD, flow cytometry) in support of clinical/preclinical development and regulatory submissions.

You will collaborate across development teams, develop and qualify bioanalytical assays, manage project timelines, ensure GLP/GDP compliance, and document results in analytical reports.