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Associate Director, Cell Therapy Process Development
Company: Johnson & Johnson
Location: Spring House, PA
Employment Type: Full Time
Date Posted: 09/11/2021
Expire Date: 10/13/2022
Job Categories: Biotechnology and Pharmaceutical, Healthcare, Other, Healthcare, Practitioner and Technician, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Medical, Writing/Authoring
Job Description
Associate Director, Cell Therapy Process Development

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Associate Director, Cell Therapy Process Development to join a growing team focused on cell therapy process development for the development of innovative treatments for cancer. The position is a key part of the growing API Cell and Gene Therapy Organization located in Spring House, PA site.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.

 

We are looking for an energetic, highly-motivated and collaborative associate director candidate with demonstrated expertise in allogeneic cell therapy process development with an emphasis on iPSC derived immune effector cell products. The successful candidate will lead a team focused on translating the promise of allogeneic cell therapies into clinical and commercial products for the treatment of hematological and solid tumor cancers. S/he will lead a team tasked with unit operation development, process development, process scale-up and scale out in combination with process parameter optimization resulting in the development of new production processes for cGMP Manufacturing. The successful candidate will work as part of a cross-functional teams supporting pre-clinical and clinical programs, focused on genetically engineered allogeneic iPSC processes.

 

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

  • Leverage own extensive experience in cell therapy process development to influence and guide allogeneic platform and process development efforts focused on hypoimmunogenic iPSC derived effector cells.
  • Develop future iPSC derived cell therapy pipeline processes, keeping the requirements of clinical and commercial manufacturing in mind
  • 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.
  • Identify, critically assess and evaluate opportunities to improve manufacturing outcomes such as improving success rate, throughput, reducing cost, process time and product quality of the final drug product.
  • Utilize phase-appropriate process development strategies to identify process parameters and appropriate ranges using QbD principles as applied to cell therapy.
  • Dive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners.
  • Communicate program progress and issues to senior management, to regulatory agencies as necessary, and at national and international conferences as appropriate
  • Other duties, as necessary

Qualifications

Education:

  • 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).

 

Experience and Skills:

  • Knowledge of biology/immunology/biochemistry as applied in cell and gene therapy processes is required
  • Knowledge and experience in allogeneic CAR-T cell therapy and T cell biology is required, experience with iPSC cells is highly preferred. Fundamental immunology expertise with prior hands-on experience with equipment and unit operations typically used in process development and manufacture of cell therapy products is also required.
  • Experience with cell culture bioreactor operations and process scale up with application to cell therapy is required; expertise in gene editing and flow cytometry advantageous
  • Proven leadership skills and problem-solving experience in cell therapy industry with an emphasis on pipeline projects is required.
  • Deep understanding of biologics industry process development strategies and best practices as applied from early development to late stage and commercialization is required.
  • S/he must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data is required.
  • Have deep intellectual curiosity, and excellent communication, interpersonal and collaborative skills
  • Highly adaptable and responsive, and committed to completing tasks in a timely fashion
  • Demonstrated ability to work in a dynamic environment as a team player with a strong work ethic
  • Occasional weekend work may be required

 

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


Primary Location
United States-Pennsylvania-Spring House-Welsh & McKean Roads
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D
Requisition ID
2105967061W
Contact Information
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