Associate Director, Product Characterization – In Vivo CAR-T

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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

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.

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 anAssociate Director Product Characterization In Vivo CAR-T to be in Malvern PA.

Purpose:

The Therapeutics Development and Supply Analytical Development (AD) organization is seeking a highly skilled and dedicated Associate Director of Analytical Development to join our Cell and Gene Therapy Analytical Development leadership team. The individual will work with cross-functional teams to develop comprehensive phase-appropriate product characterization approaches for in vivo CAR-T that support product understanding development decisions and health authority expectations. This role is critical in driving the development and execution of innovative analytical comparability and product characterization strategies ensuring the successful advancement of our innovative therapies through global regulatory filings.

You will be responsible for:

• Lead and manage a team of scientists focused on analytical comparability and product characterization for In Vivo and ex vivo cell therapy ensuring robust strategy development in alignment with statistical rigor and global health authority expectations

• Oversee the ideation development and implementation of advanced analytical methodologies associated with comparability and deep characterization of cell and gene therapy products.

• Set the overarching scientific and technical strategy for in vivo CAR-T lentivector characterization shaping cross-functional product understanding and control strategy to support portfolio decisions regulatory readiness and advancement of next-generation cell and gene therapy platforms.

• Lead development of phase-appropriate CQA and control strategy frameworks for targeted lentiviral vectors linking process parameters product quality attributes mechanism of action transduction efficiency biodistribution insertional risk and functional CAR-T cell generation to support development decisions.

• Apply deep immunology and lentivector mechanism expertise to guide product characterization strategy including understanding of immune cell targeting in vivo transduction biology vector-mediated CAR expression and functional generation of therapeutic CAR-T cells.

• Drive strategic scientific communication for internal governance senior leadership external partners and regulatory interactions ensuring complex technical data are translated into clear recommendations and development decisions.

• Collaborate cross-functionally with Process Development Translational Discovery quality assurance regulatory affairs and manufacturing teams to integrate analytical strategies within the broader development processes.

Qualifications:

• Ph.D. in Immunology Biochemistry Virology Molecular Biology Bioengineering or Analytical Chemistry Pharmaceutical Sciences or a related field.

• A minimum of 68 years of relevant industry experience in analytical development for advanced therapy modalities including demonstrated scientific leadership cross-functional influence and strategy ownership in cell and gene therapy development.

• Deep scientific expertise in immunology and lentivector mechanisms with strong understanding of immune cell biology in vivo gene delivery vector targeting transduction CAR expression and functional T cell biology as applied to in vivo CAR-T therapeutic development.

• In-depth knowledge of regulatory requirements and industry best practices related to analytical comparability and product characterization.

• Strong leadership communication and interpersonal skills with a proven ability to influence stakeholders and drive collaborative efforts.

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 () or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning Biochemistry Chemistry Manufacturing and Control (CMC) Clinical Research and Regulations Clinical Trial Designs Developing Others Drug Discovery Development Inclusive Leadership Leadership Molecular Diagnostics Pharmacovigilance Process Improvements Productivity Planning Program Management Quality Assurance (QA) Scientific Research Tactical Planning Team Management Troubleshooting