Principal Scientist, Product Characterization – Advanced Therapies

Location: Malvern, Pennsylvania; Spring House, Pennsylvania; or Leiden, Netherlands

Base pay: €68,600–€119,600 annually

Company

Johnson & Johnson MedTech develops healthcare innovations and therapies intended to prevent, treat, and cure complex diseases.

What you will do

• Define and implement product characterization strategies for in vivo CAR-T, LNP, mRNA, and targeted lentiviral vector modalities.
• Identify and justify critical quality attributes for cell and gene therapy products using Quality by Design principles.
• Lead comparability studies and deep characterization using advanced analytical methodologies.
• Develop control strategies linking process parameters to product quality attributes, applying DOE and statistical modeling.
• Author or coordinate IND, IMPD, BLA, and MAA sections and respond to product characterization questions from regulatory agencies.
• Collaborate with Process Development, Data Sciences, Supply Chain, Quality Assurance, Discovery, academic partners, and industry partners.

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/Master’s degree with 6–8 years of relevant experience.
• 2+ years of analytical control strategy experience for advanced therapy medicinal products, including CAR-T, lentiviral vectors, or gene therapy products.
• Expertise in critical quality attribute assessment and control strategy development for advanced therapies.
• Experience designing, executing, and optimizing orthogonal analytical characterization techniques for cell and gene therapy products.
• Strong scientific communication, organization, interpersonal, and collaboration skills in a complex matrix environment.
• Ability to mentor junior scientists and technicians and manage multiple priorities under tight timelines.

Nice to have

• Experience with analytical reasoning, biotechnology, CMC, molecular diagnostics, clinical research and regulations, or drug discovery and development.
• Experience contributing to scientific forums, SOPs, best practices, and innovative characterization approaches.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Annual bonus with a target based on pay grade and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Eligibility for insurance plans, service anniversary awards, and recognition awards.