Scientific Director, In-vivo CAR-T

Company Overview

Johnson & Johnson is a leading healthcare company dedicated to innovating medical solutions and improving health worldwide. We foster an inclusive work environment and value the diversity and dignity of our employees.

Scientific Director, In‑vivo CAR‑T

Spring House, PA or Malvern, PA

The Scientific Director will provide strategic scientific guidance for in‑vivo CAR‑T programs from new molecule development through commercial licensure. This role leads CMC and scientific strategy, drives control strategy across programs, and builds organizational capability through mentoring and knowledge sharing.

• 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 shape the regulatory landscape and accelerate approval pathways.
• Collaborate closely with internal partners (Supply Chain, Regulatory, Quality, Discovery, and 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.
• Influence across disciplines with senior leaders and external partners to drive and align strategic and operational scientific activities between business functions.

• Ph.D. in cell biology, immunology, biological science, or related discipline with at least 10–12 years of experience, or an M.S. with 15 years of experience focused on CAR‑T therapies.
• Proven track record in CMC development with demonstrated successes in IND and BLA approval.
• Experience leading technical/scientific teams and direct or indirect people‑management responsibilities.
• Excellent written and oral communication skills and ability to influence peers, superiors, and partners.
• Primary in‑depth experience in cell therapy development.
• Strong interpersonal skills and ability to adapt effectively in a complex, matrix/functional environment.
• Self‑motivated with the ability to make difficult decisions in a timely fashion.
• Strong problem‑solving and organizational 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

• Biochemical and molecular biology expertise
• Experience with CAR‑T platform development
• Familiarity with regulatory strategy for cell therapy
• Leadership in cross‑functional teams
• Proficiency in project management and execution

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. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra‑) or contact AskGS to be directed to your accommodation resource.