Scientific Director, In-vivo CAR-T

Johnson & Johnson

Scientific Director providing strategic guidance for In-vivo CAR-T programs at Johnson & Johnson. Leading CMC strategy and collaborating with internal partners to drive scientific activities.

Posted 7/7/2026full-timeSpring House • Pennsylvania • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in In-Vivo CAR-T CMC development, including process development, formulation strategies, and regulatory compliance. Proven ability to lead cross-functional teams and drive strategic scientific initiatives while influencing stakeholders and managing complex technical challenges.

Highest-signal resume keywords

Ph.D. In Cell BiologyCMC DevelopmentIND And BLA ApprovalCell Therapy DevelopmentTechnical And Scientific Leadership

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Applicant Tracking System Keywords

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Hard Skills

Process DevelopmentFormulation StrategiesTechnical DOE DesignControl Strategy DevelopmentRisk AssessmentRegulatory Document PreparationManufacturing InvestigationsTechnical Problem-SolvingDecision-MakingScientific Publication

Soft Skills

Excellent Communication SkillsInterpersonal SkillsCollaborationSelf-MotivationOrganizational Skills

Industry Keywords

In-Vivo CAR-TRegulatory ComplianceCross-Departmental CollaborationStakeholder EngagementMatrix Environment

About the role

Key responsibilities & impact

Provide strategic scientific guidance for in Vivo CAR-T programs in development from New Molecule entity through commercial licensure activities.
Lead CMC and scientific strategy for In‑Vivo CAR‑T development, driving control strategy across programs.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
401(k) retirement plan
Paid time off
Professional development opportunities
Flexible work arrangements