At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country (s) that align with your preferred location (s):

United States – Requisition Number: R-018519

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

We are searching for the best talent for an Associate Director, CAR-T Analytical Scientific Integrator - Advanced Therapies to be located in Malvern, PA or Leiden, Netherlands.

Purpose: The Associate Director, CAR-T Analytical Scientific Integrator will provide analytical, technical and strategic leadership to a matrixed team, in addition to representing Advanced Therapy (BioTD-AD) on the CMC team(s). This role is also responsible for working with teams in the preparation of technical documents and regulatory submissions, participating in review, and contributing to development of strategies to follow global requirements.

You will be responsible for:

• Representing analytical development to provide strategic and scientific guidance to CMC project teams for all analytical topics including method development, control strategy and regulatory filings supporting FIH through commercial licensure.
  
• Leading the development and execution of analytical strategy, including shaping the strategy to meet global health authority expectations.
  
• Leading the analytical review of each program at governance meetings with support from subject matter experts.
  
• Ensuring the submission of complete, consistent, comprehensive, high-quality dossiers.
  
• Effectively communicating project status, resources and issues to senior management.
  
• Partnering with Business integrator to ensure accurate and forecasting aligned to CMC deliverables.
  
• Representing analytical at health authority inspections and meetings with health authorities.
  
• Project risk management, including creation of the risk register, developing appropriate risk mitigation strategies and heightened concerns.
  
• Interacting and influencing various internal and external partners such as Commercial Manufacturing, Regulatory, Quality, Discovery, external partners, and health authorities.
  
• Additional responsibilities include method transfers to commercial sites, analytical control strategy, justification of specifications, and criticality analysis.

Qualifications / Requirements:

Education:

• PhD in Biochemistry, Immunology, Virology, Biological Science, or a related field with 6 years of biopharmaceutical development experience OR Master’s degree with 8 years of experience in biopharmaceutical development is required.

Experience and Skills:

Required:

• At least 2 years of experience on cross-functional CMC teams is required.
  
• In-depth analytical development experience in cell therapy & viral vector is required.
  
• Knowledge of basic immunology techniques is required, (mammalian cell culture, FACS, immunofluorescence, ELISA, and qPCR preferred).
  
• Ability work collaboratively in a complex, environment is required.
  
• Excellent oral and written communication skills are required.
  
• Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required.

Preferred:

• Strong negotiation skills with a proven ability to implement and get results in a complex environment is preferred.
  
• Knowledge of potency assays and/or cellular immunology is preferred.
  
• Experience with the development and registration of cell therapy products is preferred.
  
• Ability to make timely decisions and operate effectively in times of ambiguity is preferred.
  
• Strong analytical problem solving, planning and organizational skills are preferred.

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