Johnson & Johnson is recruiting for an Associate Director, Cell Therapy Process Development based 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/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
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We are looking for an energetic and highly motivated Associate Director candidate with demonstrated expertise in autologous cell therapy process development, with an emphasis on CAR-T modified immune effector cell products. The successful candidate will lead a team focused on the development of the next generation of autologous 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 integration of new equipment/technologies, unit operation development and end-to-end process development, resulting in transformative manufacturing processes with enabling COGs ranges for cGMP Manufacturing. 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 process development to guide autologous platform and process development efforts focused on T-cell derived effector cells.
- Develop future autologous 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
