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Associate Director, CART Analytical Scientific Integrator

  • Título Associate Director, CART Analytical Scientific Integrator
  • Função R&D
  • Sub função R&D
  • Local Malvern, Pennsylvania, United States
  • Postado
  • ID obrigatória 2206088392W
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Descrição

Janssen Research and Development, LLC. is recruiting for an Associate Director, CAR-T Analytical Scientific Integrator (Cell Therapy Analytics) in the Biotherapeutics Development - Analytical Development (BioTD - AD) group 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. 

Janssen Research and Development, LLC develops treatments that improve the health and lifestyle of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Scientific Integrator (SI) /Associate director will lead the strategies for our autologous and allogenic cell therapies.  The individual would provide analytical technical and strategic leadership, in addition to representing analytical development on the CMC team(s).

Key Responsibilities:

  • Provide strategic and scientific guidance in analytical development, control strategy and regulatory filing to analytical integrators supporting FIH through commercial licensure.
  • Ensure matrix leaders within the function:
    • Develop cross-functional scientific team consisting of members from each of the analytical sub-functions.
    • Lead the development and execution of analytical strategy, including shaping the strategy to meet global health authority expectations.
    • Be accountable to the CMC team for all analytical deliverables.
    • Responsible for leading the analytical review of each program at governance meetings with support from subject matter experts.
    • Ensure the submission of complete, consistent, comprehensive, high-quality dossiers.
    • Effectively communicate project status, resources, budget, and issues to senior management.
    • Represent analytical at health authority inspections and meetings with health authorities.
    • Accountable for project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and escalation of issues.
    • Interact and influence with various internal and external stakeholders such as Commercial Manufacturing, Regulatory, Quality, Discovery, external partners, and HA.
    • Additional responsibilities include method transfers to commercial sites, analytical control strategy, justification of specifications, and criticality analysis.

Qualificações

Experience and Skills:

Education:

  • M.S. with 8 years of experience in biopharmaceutical development
  • Ph.D. in Biochemistry, immunology, virology, biological science, or related discipline with 6 years of experience in biopharmaceutical development

Required:

  • At least 2 years of experience on cross-functional CMC teams
  • In-depth analytical development experience in cell therapy & viral vector
  • Ability work collaboratively in a complex, matrix environment
  • Excellent oral and written communication skills
  • Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment

Preferred:

  • Strong negotiation skills with a proven ability to execute and get results in a matrix environment
  • Knowledge of potency assays and/or cellular immunology
  • Knowledge of basic immunology techniques is required, including mammalian cell culture, FACS, immunofluorescence, ELISA, and qPCR
  • Experience with the development and registration of cell therapy products
  • Ability to make timely decisions and operate effectively in times of ambiguity
  • Strong analytical problem solving, planning and organizational skills

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location. 

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

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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