Principal Scientist, Product Characterization – Advanced Therapies

Scorpion Therapeutics; Spring House (PA); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Johnson & Johnson seeks a Principal Scientist in Product Characterization for Advanced Therapies to drive characterization strategies for CAR-T, LNP, mRNA, and viral vectors. The role focuses on CQAs, regulatory alignment, and collaboration across functions.

You will lead assay development, perform deep characterization, and apply DOE/statistical methods to support IND/IMPD/MAA submissions in a matrix environment located in PA and NL.

Qualifications

• Ph.D. or equivalent in Biochemistry, Immunology, Virology, or related field.
• 3+ years (or 6-8 years for Bachelor’s/Master’s) with analytical control strategy for ATMPs such as CAR-T/gene therapies.
• Expertise in analytical techniques for cell/gene therapies and strong communication.

Responsibilities

• Lead assay development and deep characterization and comparability studies.
• Establish control strategies linking process parameters to CQAs.
• Apply DOE and statistical modeling to optimize assays.
• Author technical documentation and collaborate with cross-functional teams.
• Stay updated on industry and regulatory guidelines and contribute to SOPs.

Skills

Analytical development

QbD/CQAs

DOE & statistics

Technical leadership

Cross-functional collaboration

Education

Ph.D. in Biochemistry/Immunology/Virology

Job description

Role:

Principal Scientist in Product Characterization for Advanced Therapies at Johnson & Johnson, focusing on cell and gene therapies including CAR-T, LNP, mRNA, and viral vectors.

Objectives:

• develop and implement comprehensive characterization strategies aligned with regulatory standards;
• define CQAs using QbD principles;
• support IND/IMPD/BLA/MAA submissions.

Responsibilities:

• lead assay development
• deep characterization, and comparability studies
• establish control strategies linking process parameters to CQAs
• apply DOE and statistical modeling
• author technical documentation
• collaborate with cross-functional teams and external partners
• stay updated on industry and regulatory guidelines
• contribute to SOP development

Qualifications:

Ph.D. or equivalent in Biochemistry, Immunology, Virology, or related field with 3+ years (or 6-8 years for Bachelor’s/Master’s), including at least 2+ years in analytical control strategy for ATMPs such as CAR-T and gene therapies.

Skills:

expertise in analytical techniques for cell/gene therapies, CQA assessment, technical communication, and team mentorship.

Work setup:

location options include PA and Netherlands, with a requirement for collaboration within a matrix environment.