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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category: People Leader
All Job Posting Locations: Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America
Job Description: 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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
We are searching for the best talent for a Scientific Director, In-vivo CAR-T to be based in Spring House, PA or Malvern, PA.
There is a pre-identified candidate for this position, but all candidates will be considered.
Purpose:
The Individual will provide strategic scientific guidance for in Vivo CAR-T programs in development from New Molecule entity through commercial licensure activities. Role leads CMC and scientific strategy for In‑Vivo CAR‑T development, driving control strategy across programs. Builds organizational capability through mentoring, knowledge sharing, and advancing innovative scientific opportunities into practical development plans.
Responsibilities include the following:
• Develop and implement technical approaches for In‑Vivo CAR‑T CMC development, including process and formulation strategies.
• Lead end-to-end CMC strategy (process development, formulation, scale-up, and tech transfer) with direct impact on program scientific objectives.
• Design technical DOEs to establish and validate the control strategy and ensure alignment with global regulatory expectations and industry best practices.
• Define and drive the scientific strategy, incorporating innovative technologies and state-of-the-art approaches for In‑Vivo CAR‑T.
• Identify, analyze, and resolve high‑impact, complex cross‑departmental technical issues and manufacturing investigations; establish clear resolutions and decision points.
• Own and proactively shape the product control strategy, risk assessments, and critical quality attribute framework.
• Lead preparation, review, and approval of technical and regulatory documents, including regulatory filings, patents, and scientific publications.
• Influence and engage external stakeholders and health authorities to help shape the regulatory landscape and accelerate approval pathways.
• Collaborate closely with internal partners (Supply Chain, Regulatory, Quality, Discovery, external partners) to align development, manufacturing, and commercialization activities.
• Build organizational capability and intellectual capital through mentoring, training, knowledge sharing, and scouting nascent scientific opportunities.
• Influences across disciplines with senior leaders and external partners to drive and align strategic and operational scientific activities between business functions
Qualifications:
• Ph.D. in cell biology, immunology, biological science, or related discipline with at least 10-12 years of experience or a M.S. with 15 years of experience in an academic or industry setting with a focus on CAR-T therapies.
• Proven track record in CMC development with demonstrated successes in IND and BLA approval.
• Proven track record in leading technical/scientific team(s) and direct and/or indirect people management experience.
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners is required.
• Primary in-depth experience in Cell therapy development.
• Excellent interpersonal skills with the ability to adapt effectively to manage a growing portfolio.
• Ability to work collaboratively in a complex, matrix/functional environment.
• Demonstrated ability to be self-motivated and make difficult decisions in a timely fashion. Strong problem-solving and organizational skills are required.
Johnson & Johnson is an 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, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills: Analytical Reasoning, Biochemistry, Business Savvy, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Compliance Management, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Operational Excellence, Pharmacovigilance, Process Improvements, Productivity Planning, Product Strategies, Program Management, Scientific Research, Stakeholder Management