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Discovery & Pre-Clinical/Clinical Development

Associate Director, Cell Therapy Decisional Analytics

  • Job Title Associate Director, Cell Therapy Decisional Analytics
  • Function Discovery & Pre-Clinical/Clinical Development
  • Sub Function Biotherapeutics R&D
  • Category Senior Manager, Biotherapeutics R&D (PL8)
  • Location Spring House, Pennsylvania, United States
  • Date Posted
  • Requisition Number 2406185128W
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Description

Johnson & Johnson is recruiting an Associate Director, Cell Therapy Decisional Analytics located in Spring House, PA.

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/.

We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in the development and use of a variety of rapid analytical approaches to support cell therapy and lentiviral vector process development.  The successful candidate will lead a team focused on the development and rapid utilization of a variety of analytical methods with an emphasis on high throughput, fast turnaround methodologies to drive rapid decision-making.

The successful candidate will support the development of processes supporting the next generation of autologous and allogeneic cell therapies with an emphasis on their rapid implementation for clinical and in time commercial products, enabling the advancement of these breakthrough treatments for hematological and solid tumor malignancies. S/he will lead a team tasked with the integration of new equipment/technologies and approaches to fast decisional analytical outputs to enable decision-making with respect to process development for both lentiviral vectors and cell therapy processes, resulting in transformative cGMP Manufacturing processes with breakthrough COGs.   The successful candidate will work as part of a cross-functional teams supporting pre-clinical and clinical programs, focused on CMC development. 

Primary responsibilities for this role include but are not limited to:

·         Leverage own extensive experience in cell therapy analytical technologies to guide autologous and allogeneic platform and process development efforts focused on T-cell derived effector cells.

·         Collaborate to develop decisional analytical assays and approaches to enable the rapid development of autologous Lentiviral vector and cell therapy pipeline processes, keeping the requirements of clinical and commercial manufacturing in mind.

·         Utilize start-up and lean principles to enable fast turnaround times for decisional analytical approaches, with an emphasis on speed to decision and high throughput approaches for both accurate and robust data outputs.

·         Help to drive effective decision-making while considering impact to timeline, FTEs/budget, and risks.

·         Lead, mentor and train team members. Provide effective leadership including individual performance goal setting, managing the development of entire team and all individuals, recognize and reward employee contributions, planning and facilitating team activities, responsible for hiring and selecting new personnel and motivating members of the functional area

·         Proactively mitigate potential conflicts and rapidly resolve communication problems with internal partners, cross-functional teams and third-party collaborators

·         Collaborate with and lead/participate in cross-functional teams to facilitate IND-enabling, clinical Phase I/II-enabling activities as well as BLA enabling workstreams.

·         Utilize phase-appropriate process development strategies to identify process parameters and appropriate ranges using QbD principles as applied to cell therapy.

·         Communicate proactively on progress and issues to senior management, to regulatory agencies as necessary, and at national and international conferences as appropriate.

·         Other duties, as necessary

Qualifications

·         PhD in Biological Sciences, Biomedical Engineering or Immunology with at least 9 years of relevant industry experience (academic experience post-graduate also considered) OR MS in Biological Sciences, in Biological Sciences, Biomedical Engineering or Immunology and with at least 12 years of industry experience (relevant academic experience also considered) OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 15 years of industry experience is required.

·         Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required.

·         Knowledge and experience in analytical approaches used to analytically characterize autologous & allogeneic CAR-T cell therapies, Lentiviral vector manufacturing is required.

·         Prior hands-on experience with equipment and analytical methodologies utilized in the characterization of lentiviral vectors and / or T-cell therapeutics is required.

·         Proven leadership skills and problem-solving experience in cell therapy industry with an emphasis on pipeline projects

·         Understanding of pFMEA analysis and process characterization is required, with direct experience in late-stage process development advantageous.

·         Deep understanding of biologics analytical approaches, strategies and best practices as applied to the development of cell therapies is required.

·         S/he must be detail-oriented, highly organized, and able to manage multiple tasks, handle tight timelines and deliver quality data. Must have excellent communication, interpersonal and collaborative skills.

·         Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic. Highly adaptable and responsive, and committed to completing tasks in a timely fashion.

·         Occasional weekend work may be required.

·         This role is based in Spring House, PA and may require up to 10% travel.

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, disability, 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.

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