Principal Scientist, Product Characterization – Advanced Therapies
Johnson & Johnson Innovative Medicine
Leiden, South Holland, Netherlands
On-Site
Expert
posted 44 days ago
View company profile
Vacancy Summary
Join Johnson & Johnson as a Principal Scientist in Product Characterization for Advanced Therapies. You will lead the development of product characterization strategies for In Vivo CAR-T therapies, working in a collaborative environment focused on innovative healthcare solutions.
Required skills
Quality Assurance
Procedures
Technical Writing
Innovation
Methodologies
Biochemistry
control strategies
Spring
Regulatory Affairs
Teams
Communication Skills
Assessment
Design
(D)MJOP
ATMP
Process Development
Coordinating
Data Interpretation
Healthcare
Strategy
Support
Therapy
DOE
Detail-Oriented
Lentiviral Vectors
Analytical Development
Statistical Modeling
REACH
analytical techniques
SOPs
Analytical Reasoning
Emerging Technologies
Organizing
Pharmacovigilance
Scientific Research
Clinical Research and Regulations
Molecular Diagnostics
Productivity Planning
English level
Professional
At Johnson & Johnson, we believe health is everything. Our commitment to healthcare innovation allows us to create a world where complex diseases are managed effectively. We are looking for a Principal Scientist in Product Characterization for Advanced Therapies to be based in Malvern, PA, Spring House, PA, or Leiden, Netherlands.
The Role
The Biotherapeutics Development - Analytical Development (BioTD - AD) group seeks a highly motivated Principal Scientist to focus on product characterization for advanced therapy modalities. You will develop comprehensive product characterization approaches for In Vivo CAR-T therapies that meet health authority standards. This role offers the chance to engage in multi-functional teams and contribute to leading drug discovery and development programs.
You will be responsible for:
•
Defining and implementing product characterization strategies for in vivo CAR-T, including LNP, mRNA, and targeted LV modalities from early to late development stages.
•
Leading the identification and justification of Critical Quality Attributes (CQAs) for cell and gene therapy products using Quality by Design (QbD) principles.
•
Executing advanced methodologies associated with comparability and deep characterization of cell and gene therapies.
•
Developing control strategies linking process parameters to CQAs.
•
Applying Design of Experiments (DOE) and statistical modeling to establish structure-function and process-product relationships.
•
Authoring or coordinating IND/IMPD/BLA/MAA sections and interacting with regulatory agencies on product characterization inquiries.
•
Effectively communicating characterization results and scientific data to cross-functional teams and health authorities.
•
Promoting collaboration with Process Development leaders, data sciences, Janssen Supply Chain leaders, Quality Assurance, and Discovery.
•
Contributing to technical forums to share knowledge on product characterization strategies.
•
Identifying and collaborating with academic or industry partners to implement innovative characterization approaches.
•
Staying updated with industry standards and regulatory requirements related to advanced therapies.
•
Authoring reports and presentations to communicate findings to stakeholders.
•
Contributing to the development of standard operating procedures (SOPs) for product characterization.
About Johnson & Johnson Innovative Medicine
Johnson & Johnson Innovative Medicine
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
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