Full-Time

Associate Director

Product Characterization, In Vivo CAR-T

Deadline 9/25/26
Johnson & Johnson

Johnson & Johnson

10,001+ employees

Global healthcare company offering pharma, devices.

No salary listed

Malvern, PA, USA

In Person

PhD

Category
Biology & Biotech (1)
Required Skills
Quality Assurance (QA)
Biochemistry

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Requirements
  • A Ph.D. in Immunology, Biochemistry, Virology, Molecular Biology, Bioengineering, Analytical Chemistry, Pharmaceutical Sciences, or a related field.
  • A minimum of 6–8+ 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.
Responsibilities
  • 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 critical quality attribute 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 broader development processes.
Desired Qualifications
  • Analytical reasoning.
  • Biochemistry.
  • Chemistry, Manufacturing, and Controls (CMC).
  • Clinical research and regulations.
  • Clinical trial designs.
  • Developing others.
  • Drug discovery and development.
  • Inclusive leadership.
  • Leadership.
  • Molecular diagnostics.
  • Pharmacovigilance.
  • Process improvements.
  • Productivity planning.
  • Program management.
  • Quality assurance.
  • Scientific research.
  • Tactical planning.
  • Team management.
  • Troubleshooting.

Johnson & Johnson operates in three main areas—pharmaceuticals, medical devices, and consumer health products—serving consumers, healthcare professionals, and institutions worldwide. It develops prescription medicines, sells surgical and vision care devices, and offers over-the-counter and personal care products, funded by direct sales, partnerships, and distribution agreements, with heavy investment in research and development. The company differentiates itself by combining three complementary businesses under one umbrella and maintaining a global footprint with an emphasis on science, innovation, and inclusive culture. Its goal is to help people live healthier lives by delivering reliable, high-quality healthcare products and solutions that improve patient outcomes.

Company Size

10,001+

Company Stage

IPO

Headquarters

New Brunswick, New Jersey

Founded

1886

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Simplify Jobs

Simplify's Take

What believers are saying

  • Q2 2026 sales rose 6.6% to $25.3 billion, and guidance topped $101 billion.
  • TECVAYLI's March 2026 approval and TREMFYA's May expansion expand growth before 2027.
  • The July 27, 2026 talc deal removes roughly 76,000 claims and litigation expense.

What critics are saying

  • Stelara sales fell 55.7% in Q2 2026 as Amgen and Sandoz biosimilars flooded pricing.
  • The July 2026 talc settlement still depends on 95% claimant acceptance by 2027.
  • A failed talc resolution or mega-verdict forces asbestos-style reserves, capital strain, and dividend pressure.

What makes Johnson & Johnson unique

  • J&J owns leading franchises in oncology, immunology, and medtech, spanning hospitals and consumers.
  • TECVAYLI plus DARZALEX FASPRO won U.S. approval on March 5, 2026, in earlier-line myeloma.
  • TREMFYA's May 28, 2026 label now claims joint-damage inhibition, unlike rival IL-23s.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Paid Holidays

Remote Work Options

Performance Bonus

Growth & Insights and Company News

Headcount

6 month growth

-4%

1 year growth

-4%

2 year growth

-2%
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