Description
Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Senior Scientist, Analytical Development to be located in Malvern, PA.
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The Biotherapeutics Development-Analytical Development (BioTD-AD) group is seeking an upbeat, and highly motivated Senior Scientist to support CAR-T cell therapies. The individual will be a point of contact person overseeing the development of flow cytometric and cell-based test methods for in-process and release assays to support Janssen's CAR-T drug development and production. The Senior Scientist will have the opportunity to engage in multi-functional teams. They will learn from and contribute to industry-leading drug discovery/development programs that has brought numerous quality therapeutics to patients and has made significant contributions to human health.
Key Responsibilities:

• Serve as an analytical technical expert for multi-color flow cytometry and cell-based method development and the activities associated with the automation of the methods.
• Develop, conduct, and advise on method development, optimization, and automation implementation.
• Lead and participate in scientific investigations and trouble-shoot process issues that arise during development.
• Author documentation for internal and external communication.
• Demonstrate excellent communication and interpersonal skills.
• Act as liaison and point of contact for local teams and global operations; serve as a representative on cross-functional teams.
• Work effectively in a team environment as well as contribute individually to meet project objectives and timelines.

Qualifications
Education:

• PhD with 2 years of experience OR Master's degree with 5 years of experience OR Bachelor's degree with 8 years of experience in an appropriate scientific field (i.e., Immunology, Cell biology, Biological Science, or related field) is required.

Experience and Skills:
Required:

• Strong knowledge of multi-color Flow Cytometry method development for cell-based therapies is required.
• Experience with the development and optimization of cell-based methods is required.
• Experience in method development and method qualification/validation is required.
• Experience with implementing automation for end to end (E2E) flow cytometric methods is required.
• Strong analytical problem solving, planning and organizational skills are required.
• Experience implementing and maintaining high quality standards for all aspects of work conducted including adherence to regulatory GLP/GMP, departmental, and safety guidelines is required.
• Ability to work collaboratively and manage multiple projects and workstreams simultaneously is required.
• Ability to communicate project results, findings and data to management in a clear and timely fashion is required.
• Excellent oral and written communication skills are required.

Preferred:

• Knowledge of the connections between clinical, process/product development, and biological outcomes is preferred.
• Experience with the development and registration of cell therapies is a plus.
• Awareness of GMP requirements is desired.
• Ability to make timely decisions and operate effectively in times of ambiguity is highly preferred.
• People leadership experience, working in a team or direct line setting, is a plus.

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.
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