SCIENTIST, ANALYTICAL DEVELOPMENT - CELL & GENE THERAPY

Janssen Research & Development, LLC, is recruiting for a Scientist, Analytical Development – Cell & Gene Therapy, located in Malvern, PA.
At Janssen, we never stop working toward a future where disease is a thing of the past.
We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.
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Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension.
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anssen.
om The Biotherapeutics Development - Analytical Development(BioTD-AD) – Cell & Gene Therapy(CGT) group is recruiting a highly energetic and collaborative scientist to join our CAR-T analytical development team in Malvern PA.
Successful candidate will be responsible for analytical method development for cell therapy products e.
., cell-based potency assay development, ELISA based assay development, CAR-T cell characterization assay development.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.
Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science.
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We collaborate with the world for the health of everyone in it.
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anssen.
om and follow us @JanssenGlobal.
Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.
Key Responsibilities.
Responsibility for development, qualification, validation, and transfer activities for CAR-T cell-based potency assays as well as ELISA/MSD based assay.
Incorporating automation into new method development, and adapting existing methods for automation Writing protocols, reports, and performing and coordinating testing to support analytical development, manufacturing process development, process validations, and manufacturing investigations across functional groups.
Writing analytical sections of regulatory submissions is expected and the successful candidate will support regulatory filings.
Providing technical support to QC laboratories, and assisting in investigations Accurately capturing of data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements is expected.
Qualifications Education.
A minimum of a Bachelor’s degree with at least 6 years of related experience OR Master’s degree with at least 3 years of related experience OR a PhD in Biochemistry or cell & molecular biology or immunology or related subject area with 0-1 years’ experience is required Experience and Skills.
Required.
Extensive experience with plate based biochemical assays is required Hands-on experience with ELISA assay development, optimization, and troubleshooting is required Experience with cell-based potency assay development, qualification/validation is required Great organization skills and ability to manage multiple projects simultaneously and independently is required Ability to communicate project results, finding and data to management or matrix team in an efficient manner is required Knowledge of method robustness, DoE, method design and familiarity with assay validation parameters is required Excellent interpersonal skills (written and oral) with the ability to work in a cross functional customer-focused environment is required Preferred.
Experience in Cell therapy or gene therapy functional assays is preferred Experience with Automation of ELISA assay or other cell-based assays is preferred Experience with automated liquid handlers is preferred Experience working with alternative techniques of quantification of analytes.
e.
.
cytokines via MSD is preferred Experience with cell based killing assays, cell proliferation and multiparametric flow cytometry is preferred Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
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