Senior Expert, Science & Technology - Analytical Development
Location: East Hanover, New Jersey
Internal Number: 331072BR
1 purpose! Novartis expands its early development and innovative CAR-T cell therapy capabilities for making personalized medicine accessible to more patients in need. Our therapies are being developed as transformative treatments with life-saving potential for various hematological malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.
Bench to bedside! The Senior Expert, CAR-T Analytical Development will support developmental activities. The successful candidate will support technical and development projects designed to characterize cell therapy products through an assortment of analytical methods. This role will also contribute to cross-functional activities including monitoring and characterizing of processes and products to identifying opportunities for continuous improvement.
More specifically this includes:
* Collaboratively drive projects to meet established timelines while maintaining the highest quality and data integrity standards * Perform analytical testing including next-generation sequencing (NGS) and other novel molecular techniques * Lead method development projects and implementation into Quality Control * Perform all testing and activities compliantly following appropriate SOPs and procedures. * Record and maintain meticulous records in electronic laboratory notebook in compliance with GLP/GMP standards * Review/approve data generated by other team members * Execute method qualification/optimization of methods * Continually identify areas for improvements in project work * Knowledge of appropriate GMP/GLP quality systems * Support tracking and trending systems, and programs, which assist in the testing, evaluation and monitoring of quality and efficiency * Assist in drafting and reviewing technical and regulatory documents to ensure completeness, accuracy, consistency and clarity * Present results and project updates to team