Contract, Bioanalytical Scientist, Gxp Bioanalytical, Clinical Pharmacology

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,