Job Description Summary:
Bioanalytical Scientist, GxP Bioanalytical, 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.
Bioanalytical Scientist , GxP Bioanalytical, 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.
- 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.
- 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.
- PhD in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline or Master's degree in these same disciplines with a minimum of 3 years of experience or Bachelor's degree in these same disciplines with a minimum of 5 years of experience and progressively responsible experience in regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.).
* Special knowledge or skills needed and/or licenses or certificates required.
- 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 and 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.
*Special knowledge or skills and/or licenses or certificates preferred.
- Experience in writing analytical reports, laboratory operating procedures and work instructions.
- Experience in working within or with a Contract Research Organization (CRO).
* Travel requirements Up to 10% Office/Laboratory based position EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. Click here to return to the careers page
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PTC Therapeutics, Inc
Apr 10, 2025