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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

Qualifications

• PhD in Biological Sciences, Biomedical Engineering or Immunology with at least 8 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 11 years of industry experience (relevant academic experience also considered) OR a BS in Biological Sciences, Biomedical Engineering or Immunology and with at least 13 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 autologous CAR-T cell therapy required, together with a demonstrated understanding of T cell biology, and significant knowledge of immunology is required.

• Prior hands-on experience with process automation together with equipment and unit operations typically used in process development and manufacture of autologous cell therapy products is required (such as Miltenyi Prodigy, Cytiva Xuri and cell harvest technologies); expertise in gene editing and flow cytometry analysis is advantageous

• 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 industry process development strategies and best practices as applied from early development to late stage and commercialization

• S/he must be detail-oriented, highly organized, 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.