Associate Scientist II, Analytical Development (Biological Assays) - Gene Therapy - Military Veterans

at PTC Therapeutics

Pennington, New Jersey

Job Description Summary:

Job Description:

The Associate Scientist II, Analytical Development - Gene Therapy is responsible for the development, execution, and analysis of analytical assays supporting Process Development and Manufacturing. Additional responsibilities include communicating results to management/supervisor, authoring test methods and development reports, training staff, equipment maintenance and other lab support functions as assigned.

The incumbent serves as a SME for analytical assays on cross-functional teams comprised of internal and external stakeholders in support of CMC objectives..

The Associate Scientist II, Analytical Development - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPS0 as appropriate.

Primary duties/responsibilities:

  • Develops and optimizes gene therapy product characterization assays for analytical method transfer to support process development and manufacturing including (but not limited to) qPCR, cell-based, and immunoassays.

  • Generates, reports, and archives assay data.

  • Analyzes and interprets data. Assesses data trends and proposes mitigation strategies as required.

  • Develops critical reagents, maintains cell lines, controls, standards, and reagent inventories.

  • Applies relevant scientific principles and techniques to analytical problems.

  • Maintains detailed, up to date, and witnessed laboratory notebooks.

  • Functions as a subject matter expert for analytical assays. Presents data to internal and external stakeholders as required.

  • Performs other tasks and assignments as needed and specified by management.

* Minimum level of education and years of relevant work experience.

  • A Bachelor's degree in molecular biology, virology, biochemistry or related discipline and a minimum of 8 years of relevant industry experience or a Master's degree in these same disciplines and a minimum of 4 years of relevant experience.

* Special knowledge or skills needed and/or licenses or certificates required.

  • Proficiency with the conduct of qPCR, cell-based assays, and/or immunoassays required.

  • Experience in CMC analytical and regulatory requirements, including development of product specifications and extended analytical characterization.

  • Experience with AAV product characterization and/or release testing preferred.

  • Knowledge of residual DNA, residual host cell protein, or potency assays a plus.

  • Proficiency with Microsoft Office.

  • Excellent verbal and written communication skills.

  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

  • Analytical thinker with excellent problem-solving skills and 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.

  • Small company and/or start-up experience.

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the 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.

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Pennington, New Jersey

PTC is a science-driven, patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for patients with rare disease.

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