Principal 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

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 jnj.com .

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:

Scientific/Technology

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 jnj.com .

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 a Principal Scientist, In-vivo CAR-T Potency Method Development to be located in Malvern, PA.

You will be responsible for:

• Leading in-vivo CAR-T potency strategy design and implementation
• Leading method development, validation, tech transfer, and lifecycle support activities for in-vivo CAR-T products
• Work collaboratively in a matrix environment, supporting and mentoring team members.
• Supporting regulatory filings, including INDs and BLAs.
• Representing the department on cross-functional and external teams and act as a technical expert on potency.
• Communicating complex technical concepts to partners.
• Accurately capturing data in a timely manner, including maintenance of detailed records in compliance with applicable cGMP, safety, and environmental requirements.

Qualifications / Requirements:

• PhD with 2 years of pharmaceutical or related industry experience in addition to a post-doctoral experience is required; OR a BS or MS in a relevant scientific discipline with at least 5 years of pharmaceutical or related industry experience is required.
• Experience with in-vivo CAR-T is required
• Extensive experience in cell-based potency method development for viruses and cell therapies, including assay design and method robustness is required.
• Extensive experience in potency strategies for cell and gene therapies and regulatory recommendations.
• Experience with method validation and method transfer to a QC environment; including in-depth knowledge of ICHQ14 and ICHQ2(R2) is required.
• Strong analytical problem solving, planning and organizational skills are required.

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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

#LI-Onsite

Required Skills:

PreferredSkills:

Analytical Reasoning, Biochemistry, Biotechnology, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Coaching, Critical Thinking, Drug Discovery Development, Emerging Technologies, Molecular Diagnostics, Organizing, Pharmacovigilance, Presentation Design, Process Improvements, Productivity Planning, Scientific Research