Lead Scientist, In-Vivo CAR-T Potency Method Development

Biopharma Careers; Malvern (AR); On-site; USD 180,000 - 230,000; Full time

Job summary

Johnson & Johnson in Malvern, PA, is seeking a Principal Scientist, In-vivo CAR-T Potency Method Development. You will lead in-vivo potency strategy, develop and validate potency methods, and support tech transfer and lifecycle management for CAR-T products.

The role requires PhD with postdoc/industry experience or BS/MS with extensive pharma experience, including in-vivo CAR-T and regulatory filings. Strong collaboration and data integrity are essential.

Qualifications

• PhD with 2+ years pharma or related industry experience, or BS/MS with 5+ years.
• In-vivo CAR-T experience required.
• Experience in cell-based potency method development for viruses and cell therapies.

Responsibilities

• Lead in-vivo CAR-T potency strategy design and implementation.
• Lead method development, validation, tech transfer, and lifecycle support for in-vivo CAR-T products.
• Collaborate in a matrix environment and mentor team members.
• Support regulatory filings including INDs and BLAs.
• Represent department on cross-functional/external teams as potency expert.
• Communicate complex concepts to partners.
• Capture data and maintain detailed records per cGMP/safety/environmental standards.

Skills

Analytical Reasoning

Biochemistry

Biotechnology

Chemistry

CMC

Clinical Research

Clinical Trial Designs

Coaching

Critical Thinking

Drug Discovery

Emerging Technologies

Molecular Diagnostics

Organizing

Pharmacovigilance

Presentation Design

Process Improvements

Productivity Planning

Scientific Research

Education

PhD + 2 years pharma/related

BS/MS + 5 years pharma/related

Tools

ICH Q14

ICH Q2(R2)

Job description

Johnson & Johnson in Malvern, PA, is seeking a Principal Scientist, In-vivo CAR-T Potency Method Development. You will lead in-vivo potency strategy, develop and validate potency methods, and support tech transfer and lifecycle management for CAR-T products.

The role requires PhD with postdoc/industry experience or BS/MS with extensive pharma experience, including in-vivo CAR-T and regulatory filings. Strong collaboration and data integrity are essential.