Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology
About The Position
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.
Requirements
- 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 progressively responsible experience in regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.).
- Demonstrated experience applying analytical techniques to the regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.) using LC-MS/MS, quantitative PCR (qPCR), ELISA, Mesoscale Discovery (MSD) and flow cytometry techniques.
- Applied understanding and knowledge of bioanalytical method validation guidelines governed by FDA or other global health authorities.
- Demonstrated ability to work on complex problems to produce experimental data across one or more projects.
- Demonstrated technical proficiency, scientific creativity, the ability to collaborate with others and the ability to think independently within a fast-paced, matrixed, team environment consisting of internal and external team members.
- Possesses detailed and expert knowledge of scientific principles and concepts.
- Demonstrated ability to work effectively in a multi-disciplinary team environment.
- Proficiency with Microsoft Office. particularly MS Excel and MS PowerPoint.
- Excellent verbal and written communication skills.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Demonstrates an understanding of the strategic alignment of his/her work with corporate goal(s) and demonstrates the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Nice To Haves
- Experience in writing analytical reports, laboratory operating procedures and work instructions.
- Experience in working within or with a Contract Research Organization (CRO).
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.
Benefits
- Extending life’s moments for children and adults living with a rare disease.
- Inclusive culture where everyone feels valued, respected, and empowered.
- Welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
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What This Job Offers
Career Level
Mid Level
