Contractor, GxP Bioanalytical Scientist, Clinical Pharmacology

PTC Therapeutics, Inc; Hopewell Township (NJ); Sur place; USD 48 000 - 63 000; Plein temps

Résumé du poste

PTC Therapeutics, Inc is seeking a Contractor, GxP Bioanalytical Scientist in Clinical Pharmacology to perform quantitative analyses of biological samples for clinical and preclinical development, including LC-MS/MS, qPCR, ELISA and MSD.

The role requires coordinating bioanalytical studies across projects, interpreting data, and supporting regulatory submissions while ensuring GLP/GDP compliance and cross-functional collaboration. Up to 10% travel is expected.

Qualifications

• Master's or Bachelor's with required experience in regulated bioanalysis of clinical/preclinical samples.
• Experience applying analytical techniques to regulated bioanalysis (plasma, urine, cells) using LC-MS/MS, qPCR, ELISA, MSD and flow cytometry.
• Knowledge of FDA/good laboratory practice guidelines and global health authority expectations.
• Ability to work on complex problems, collaborate in a fast-paced, matrixed team environment.

Responsabilités

• Perform quantitative analysis of biological samples for clinical/preclinical development using LC-MS/MS, qPCR, ELISA, MSD and flow cytometry.
• Develop, validate/qualify bioanalytical assays and conduct regulated bioanalysis.
• Coordinate and manage bioanalytical study timelines with cross-functional teams.
• Ensure scientific quality and regulatory compliance for bioanalytical projects (GLP/GDP).
• Support writing analytical reports and maintain detailed laboratory records.
• Present results and timelines to development program teams.

Formation

Master's degree in biology/chemistry/biochemistry/pharmaceutical sciences or pharmacology

Bachelor's degree with 2+ years regulated bioanalysis experience

Outils

LC-MS/MS

qPCR

ELISA

MSD

Flow cytometry

Description du poste

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 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 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.
• undefined
• Experience in working within or with a Contract Research Organization (CRO).

* Travel requirements

• Up to 10%

*Physical requirements (only note if the job requires physical capacity beyond general office work)

• Office/Laboratory based position

Expected Hourly Range: $35 - 46/hour. The hourly salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

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.