Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team , fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: www.ptcbio.com Job Description Summary: The Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology provides quantitative bioanalyses of biological samples in support of the clinical and/or preclinical development of small and large molecule products. The quantitative sample analyses may include LC-MS/MS, qPCR assays, cell-based assays, ligand binding assays (ELISA/MSD) and immunogenicity assays. The analyses may include those governed by FDA or other global health authority regulations. He/She will be coordinating and executing bioanalytical studies within clinical / preclinical projects, interpreting data and providing timely support to the broader development program(s) including regulatory submissions. The incumbent works cross-functionally with internal departments and external resources as part of PTC’s drug development teams. The Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . Job Description: ESSENTIAL FUNCTIONS Primary duties/responsibilities:   With guidance, performs the quantitative analysis of biological samples in support of small and large molecules clinical and/or preclinical development. This may include those governed by FDA or other global health authority regulations. With guidance, develops, validates/qualifies bioanalytical assays and conducts regulated bioanalysis. Collaborates with clinical/preclinical drug development program teams. Manages and ensures the bioanalytical project timeline is met. Responsible for the scientific quality of the bioanalytical projects in support of clinical and/or preclinical development. Abides by all safety and regulatory guidelines. May support in writing analytical reports Complies with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP). Maintains a detailed laboratory notebook. Represents the bioanalysis function on the development program teams and presents results, timelines, etc. at project team meetings. Performs other tasks and assignments as needed and specified by management.   KNOWLEDGE/SKILLS/ABILITIES REQUIRED * Minimum level of education and years of relevant work experience.   Master’s degree in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline or Bachelor’s degree in these same disciplines and a minimum of 2 years of experience and…