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Johnson & Johnson · 4 months ago

Principal Scientist, Product Characterization – Advanced Therapies

Malvern, Pennsylvania, United States of America

Full-time

Onsite

Senior Level, Lead/Staff

3+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing treatments and pioneering solutions for complex diseases. They are seeking a Principal Scientist to lead product characterization for advanced therapy modalities, working collaboratively to develop comprehensive strategies endorsed by health authorities.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Define and implement product characterization strategy for cell and gene therapy (CGT) modalities from early development to late stages of development

Lead the identification and justification of CQAs for CGT products using the Quality by Design (QbD) principles

Lead the execution of the advanced methodologies associated with comparability and deep characterization of cell and gene therapy

Develop and refine the control strategy linking process parameters to CQAs

Apply DOE and statistical modeling to establish structure- function and process-product relationships

Author or coordinate appropriate IND/IMPD/BLA/MAA sections & interact with regulatory agencies to address product characterization related inquiries

Effectively communicate characterization results and scientific data to cross-functional teams, project teams, and health authority as needed

Promote strong partnerships and collaboration with Process Development functional leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery

Contribute to technical forums both internal and external to the company to share knowledge and approaches related to deep product characterization strategies as they relate to cell and gene therapy products

Identify/collaborate with partners in academia or industry to implement innovative ideas or characterization approaches

Stay up to date with industry standards, guidelines, and regulatory requirements related to Advanced therapies, comparability studies and product characterization

Author comprehensive reports and presentations to communicate findings and technical data to internal and external stakeholders

Contribute to the development and enhancement of standard operating procedures (SOPs) and best practices for product characterization

Qualification

Analytical control strategyCQA assessmentAdvanced therapy productsStatistical analysisRegulatory submissionsMentoringInterpersonal skillsProject managementCommunication skills

Required

Ph.D. or equivalent advanced degree in Biochemistry, Immunology, Virology, Biological Science, or a related field with 3+ years of proven experience in biopharmaceutical development OR a Bachelor's or Master's degree with 6-8 years of relevant experience is required

2+ years of analytical control strategy experience on advanced therapy medicinal products (ATMP) such as CAR T, lentiviral vectors and gene therapy products

Demonstrated expertise in CQA assessment and developing control strategies for advanced therapies

Experience with the design, execution and optimization of a broad range of analytical techniques for orthogonal characterization of cell therapy and gene therapy products

Must be detail-oriented, highly organized and able to manage multiple tasks, handle tight timelines and deliver quality data

Strong written and verbal communication skills with the ability to convey complex scientific concepts clearly

Mentor and guide junior scientists and technicians in experimental design, data interpretation, and quality assurance practices

Excellent interpersonal skills with the ability to operate effectively in a dynamic work environment is required

Ability to work collaboratively in a complex, matrix environment

Preferred

Understanding of the connections between clinical, process/product development, and biological outcomes

Experience with regulatory submissions and interactions with agencies such as the FDA or EMA

Previous experience in project management or leading cross-functional teams is a plus

Proficiency in statistical analysis and equivalency assessment is a plus

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)