Principal Scientist, Product Characterization – Advanced Therapies

Johnson & Johnson

Principal Scientist defining characterization strategies for Johnson & Johnson’s in vivo CAR-T and other advanced therapy products. Leading CQA, control strategy, regulatory, and cross-functional development activities.

Posted 8/5/2026full-timeMalvern • Pennsylvania • 🇺🇸 United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in product characterization strategies for cell and gene therapy, including the application of Quality by Design principles and advanced methodologies for comparability. Proficient in analytical control strategies, regulatory interactions, and mentoring junior scientists in experimental design and quality assurance.

Highest-signal resume keywords

Ph.D. In Biochemistry, Immunology, Virology, Or Biological ScienceCQA Assessment And Control Strategy DevelopmentAnalytical Techniques For Orthogonal CharacterizationRegulatory Interactions For IND/IMPD/BLA/MAAMentoring Junior Scientists And Technicians

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Applicant Tracking System Keywords

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Hard Skills

Product Characterization StrategyQuality By Design PrinciplesComparability StudiesDesign Of Experiments (DOE)Statistical ModelingAnalytical Control StrategyCell And Gene Therapy ProductsProcess-Product RelationshipsTechnical Report WritingSOP Development

Soft Skills

Detail-OrientedHighly OrganizedStrong Written CommunicationStrong Verbal CommunicationExcellent Interpersonal Skills

Industry Keywords

Advanced Therapy Medicinal ProductsCAR TLentiviral VectorsGene TherapyRegulatory RequirementsProduct CharacterizationComparability StudiesBiopharmaceutical DevelopmentCross-Functional CollaborationDynamic Work Environment

About the role

Key responsibilities & impact

Define and implement product characterization strategy for in vivo CAR-T, including LNP, mRNA, and targeted LV modalities from early through late-stage development
Lead identification and justification of CQAs for CGT products using Quality by Design principles
Lead advanced methodologies for comparability and deep characterization of cell and gene therapy products
Develop and refine control strategies linking process parameters to CQAs
Apply DOE and statistical modeling to establish structure-function and process-product relationships
Author or coordinate IND/IMPD/BLA/MAA sections and interact with regulatory agencies on product characterization inquiries
Communicate characterization results and scientific data to cross-functional and project teams and health authorities
Partner with Process Development, data sciences, Janssen Supply Chain, Quality Assurance, and Discovery leaders
Contribute to internal and external technical forums on product characterization strategies for cell and gene therapy products
Identify and collaborate with academic or industry partners on innovative characterization approaches
Monitor industry standards, guidelines, and regulatory requirements for advanced therapies, comparability studies, and product characterization
Author reports and presentations communicating findings and technical data
Contribute to SOPs and best practices for product characterization
Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices

Requirements

What you’ll need

Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of biopharmaceutical development experience, or a Bachelor's or Master's degree with 6–8 years of relevant experience
2+ years of analytical control strategy experience on advanced therapy medicinal products such as CAR T, lentiviral vectors, and gene therapy products
Expertise in CQA assessment and developing control strategies for advanced therapies
Experience designing, executing, and optimizing analytical techniques for orthogonal characterization of cell and gene therapy products
Detail-oriented, highly organized, and able to manage multiple tasks and tight timelines while delivering quality data
Strong written and verbal communication skills for clearly conveying complex scientific concepts
Experience or ability to mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices
Excellent interpersonal skills and ability to operate effectively in a dynamic work environment
Ability to work collaboratively in a complex, matrix environment

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Johnson & Johnson Website LinkedIn All Job Openings 10,000+ employees 🏥 Healthcare 💊 Pharmaceuticals 🧬 Biotechnology Healthcare
Pharmaceuticals
Biotechnology <Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives. Principal Scientist, Product Characterization – Advanced Therapies Job not on LinkedIn 🔥 31 minutes ago 🏢 Malvern – Onsite ⏰ Full Time 🔴 Lead 🧬 Research Scientist 🦅 H1B Visa Sponsor Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Define and implement product characterization strategy for in vivo CAR-T, including LNP, mRNA, and targeted LV modalities from early through late-stage development
Lead identification and justification of CQAs for CGT products using Quality by Design principles
Lead advanced methodologies for comparability and deep characterization of cell and gene therapy products
Develop and refine control strategies linking process parameters to CQAs
Apply DOE and statistical modeling to establish structure-function and process-product relationships
Author or coordinate IND/IMPD/BLA/MAA sections and interact with regulatory agencies on product characterization inquiries
Communicate characterization results and scientific data to cross-functional and project teams and health authorities
Partner with Process Development, data sciences, Janssen Supply Chain, Quality Assurance, and Discovery leaders
Contribute to internal and external technical forums on product characterization strategies for cell and gene therapy products
Identify and collaborate with academic or industry partners on innovative characterization approaches
Monitor industry standards, guidelines, and regulatory requirements for advanced therapies, comparability studies, and product characterization
Author reports and presentations communicating findings and technical data
Contribute to SOPs and best practices for product characterization
Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices 🎯 Requirements
Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of biopharmaceutical development experience, or a Bachelor's or Master's degree with 6–8 years of relevant experience
2+ years of analytical control strategy experience on advanced therapy medicinal products such as CAR T, lentiviral vectors, and gene therapy products
Expertise in CQA assessment and developing control strategies for advanced therapies
Experience designing, executing, and optimizing analytical techniques for orthogonal characterization of cell and gene therapy products
Detail-oriented, highly organized, and able to manage multiple tasks and tight timelines while delivering quality data
Strong written and verbal communication skills for clearly conveying complex scientific concepts
Experience or ability to mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices
Excellent interpersonal skills and ability to operate effectively in a dynamic work environment
Ability to work collaboratively in a complex, matrix environment Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs