Contract, Bioanalytical Scientist, Gxp Bioanalytical, Clinical Pharmacology

PTC Therapeutics, Inc.; Pennington (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An innovative company is seeking a Bioanalytical Scientist to join their team. This role involves performing quantitative analyses of biological samples to support clinical and preclinical development. The ideal candidate will have a strong background in analytical techniques such as LC-MS/MS and qPCR, along with excellent problem-solving and communication skills. In this office/laboratory-based position, you will collaborate cross-functionally, ensuring compliance with regulatory standards while contributing to impactful projects. This is a fantastic opportunity to make a significant difference in the field of clinical pharmacology.

Qualifications

• Educational background in relevant fields is essential.
• Experience in bioanalytical techniques is crucial.

Responsibilities

• Conduct quantitative analysis of biological samples.
• Develop and validate bioanalytical assays.
• Ensure compliance with GLP and GDP standards.

Skills

LC-MS/MS

qPCR

ELISA

Flow Cytometry

Microsoft Office

Communication Skills

Problem-solving Skills

Organizational Skills

Education

PhD in relevant field

Master's in relevant field

Bachelor's in relevant field

Job description

Contract, Bioanalytical Scientist, Gxp Bioanalytical, Clinical Pharmacology

Join to apply for the Contract, Bioanalytical Scientist, Gxp Bioanalytical, Clinical Pharmacology role at PTC Therapeutics, Inc.

Job Description Summary

The Bioanalytical Scientist, GxP Bioanalytical, Clinical Pharmacology provides quantitative bioanalyses of biological samples supporting the clinical and preclinical development of small and large molecule products. The analyses include LC-MS/MS, qPCR, cell-based assays, ligand binding assays (ELISA/MSD), and immunogenicity assays, governed by FDA or other global health authority regulations.

They coordinate and execute bioanalytical studies within clinical/preclinical projects, interpret data, and support regulatory submissions. The role involves working cross-functionally with internal departments and external resources, ensuring compliance with regulatory requirements and SOPs.

Essential Functions

• Perform quantitative analysis of biological samples supporting development projects.
• Develop, validate, and conduct regulated bioanalytical assays.
• Ensure scientific quality of bioanalytical projects.
• Maintain safety and regulatory compliance.
• Support analytical report writing and documentation.
• Adhere to GLP and GDP standards.
• Maintain detailed laboratory notebooks.
• Perform additional tasks as assigned.

Knowledge/Skills/Abilities

• Relevant educational background: PhD, Master’s, or Bachelor’s with experience.
• Experience with analytical techniques like LC-MS/MS, qPCR, ELISA, MSD, flow cytometry.
• Knowledge of bioanalytical method validation guidelines.
• Ability to work on complex problems and collaborate effectively.
• Proficiency with Microsoft Office.
• Excellent communication skills.
• Strong problem-solving and organizational skills.
• Preferred: experience with CROs, report writing, and laboratory procedures.

Additional Details

Position is office/laboratory based with up to 10% travel. PTC is an equal opportunity employer, welcoming applicants from diverse backgrounds.