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Senior Scientist, Cell Therapy Method Development

4-6+ years
Not Disclosed
10 Sept. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/ B.Pharma/ M.Pharma/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Senior Scientist, Cell Therapy Method Development


Company

Johnson & Johnson


Location

Malvern, Pennsylvania, United States of America

Fully Onsite


Job Function

Discovery & Pre-Clinical/Clinical Development


Job Sub-Function

Biotherapeutics R&D


Job Category

Senior Scientist, Biotherapeutics R&D (ST6)


Requisition Number

R-030670


Date Posted

September 4, 2025


Application Deadline

September 12, 2025 (may be extended)


Company Overview

Johnson & Johnson is a global healthcare innovator committed to developing smarter, less invasive, and personalized treatments to prevent, treat, and cure complex diseases.

Learn more: jnj.com


About Innovative Medicine

  • Patient-inspired, science-based advancements

  • Teams dedicated to developing next-generation medicines

  • Committed to translating research from lab to life

Learn more: jnj.com/innovative-medicine


Role Summary

The Senior Scientist in Cell Therapy Method Development will focus on potency analytical development for cell therapy products, specifically lentivirus and CAR-T cells. This role supports method development, validation, tech transfer, and lifecycle management of cell-based potency assays.


Key Responsibilities

  • Lead development, validation, tech transfer, and lifecycle support for cell-based potency methods.

  • Collaborate and mentor team members within a matrix environment.

  • Support regulatory filings including INDs and BLAs.

  • Represent the department in cross-functional and external teams as a potency technical expert.

  • Communicate complex technical concepts clearly to partners.

  • Maintain detailed, accurate data records compliant with cGMP, safety, and environmental regulations.


Qualifications

Education

  • Bachelor’s degree minimum required.

  • Advanced degree (Master’s or PhD) preferred.

  • PhD or equivalent advanced degree in Biochemistry, Virology, Biological Science, or related field; OR

  • Master’s degree with 4+ years experience in biopharmaceutical development; OR

  • Bachelor’s degree with 6+ years relevant experience.

Experience

  • 4-6+ years in pharmaceutical, industry, or academic biotherapeutics development.

  • Extensive experience with cell-based potency assay development for viruses and cell therapies, including assay design and robustness.

  • Deep understanding of potency strategies for cell therapies and regulatory expectations.

  • Experience in method validation and transfer to QC environments, with knowledge of ICH Q14 and ICH Q2(R2).

Skills

  • Detail-oriented, highly organized, capable of managing multiple tasks and deadlines.

  • Strong written and verbal communication skills for conveying complex scientific concepts.

  • Analytical problem-solving, planning, and organizational abilities.


Additional Information

  • Johnson & Johnson is an Equal Opportunity Employer.

  • We actively seek candidates who are protected veterans or individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

  • Accommodations are available upon request during the interview process.


Accommodation Contact

Email: ra-employeehealthsup@its.jnj.com
Or contact AskGS for accommodation resources.


Tags

#LI-Onsite