Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Analytical Scientist, CAR-T located in Malvern, PA.

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. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

We are seeking a highly energetic and collaborative, Scientist to join our CAR-T Analytical Development team.

Key Responsibilities:

• Serve as an analytical technical expert for CAR-T in-process and release methods.
• Lead method development, qualification, validation and transfer activities, which includes, writing protocols, reports, and performing and coordinating testing to support manufacturing process development, process validations, and manufacturing investigations.
• Maintain laboratory notebooks and prepare written protocols and reports in a GMP compliant manner.
• Perform instrument IQ/OQ/PQ, review logbooks and maintain general laboratory operations.
• Collaborate with QA and regulatory agencies during audits.
• Accurately capture data in a timely manner, ensuring data integrity and protocol compliance.

Qualifications

Education:

• PhD in Biology, Immunology or other relevant scientific field with at least 2 years of relevant experience OR Master’s degree, with at least 6-7 years of relevant experience OR Bachelor’s degree, with at least 9 years of relevant experience is required.

Experience and Skills:

Required:

• Experience in analytical method development and method/validation process is required.
• Knowledge of basic immunology techniques is required, including mammalian cell culture, immunofluorescence, ELISA, and flow cytometry.
• Capacity to be highly organized and capable of managing/pursuing multiple projects independently is required.
• Ability to communicate project results, findings and data to management in a clear and timely fashion is required.

Preferred:

• Excellent interpersonal skills (written and oral) and the ability to work in a cross-functional customer-focused environment is preferred.
• Hands-on experience with CAR-T or other cell and gene therapy products is preferred.
• CMC experience is preferred.
• Experience working in a cGMP environment is preferred.
• Knowledge of potency assays and/or cellular immunology 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.careers.jnj.com.