Fellow Scientist
The Novartis Cell and Gene Technical development and Manufacturing team is seeking a Fellow Scientist in Morris Plains, NJ.
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Novartis recently received the first ever FDA approval for a CAR-T cell therapy, Kymriah™, for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy, a one-time treatment that uses a patient's own T cells to fight cancer, and is the first therapy based on gene transfer approved by the FDA. Kymriah will be manufactured for individual patients using their own cells at the Novartis Morris Plains, New Jersey facility where Novartis continues to advance its CAR-T manufacturing expertise.
Job Purpose
Establish, manage and own T-cell process development/characterization to support new INDs and subsequent Technical transfer for future Cell & Gene Therapy projects
Major Accountabilities
Master Batch Record Lifecycle:
• Contribute and/or lead interdisciplinary technical development work for advanced therapy projects CGT.
• Interface with external partners to lead and monitor outsourcing activities and ensure deliverables according to Novartis standards.
• Coach global team members, participate in global teams and contribute to overall CGT strategies and goals.
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level.
• Ensure quality, quantity and timelines in all assigned projects, networks and/or platforms.
• Design, plan and perform scientific experiments/plant activities and plan, perform and contribute to project related scientific/technical activities (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, write reports).
• Provide efficient and robust processes for the manufacture and/or analysis of intermediates, DS and DP under adequate guidance from more experienced team members.
• Generate scientific documents to hand over to internal and/or external partners (e.g., TechOps, authorities, external companies) and support generation of international registration documents under adequate guidance from more experienced team members.
• Contribute to risk analyses and/or peer review and process challenge meetings
• Interact/collaborate with other groups/functions to facilitate transfer of knowledge and deliveries of DS and/or DP.
• Provide leadership to direct reports, as well as career development, training, etc.
• Give guidance to team members and work according to appropriate SOP's, GLP, GMP, OQM, HSE, ISEC and Novartis guidelines.
• Utilize special tools/equipment and/or specialized facilities e.g., containment/sterile labs as an expert.
• Evaluate new lab equipment and prepare CAR and USR if applicable.
• Report and present scientific/technical results internally and contribute to publications, presentations and patents.
• Actively contributes to team goals.
• Ensure all own activities are aligned with overall drug development process.
• Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines.
• Strategic and scientific contribution to Networks, target achievements according to network charter and annual objectives.
Key Performance Indicators
• Adherence to costs, quality, quantity, and timelines for all assigned tasks.
• Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE), and information security (ISEC) standards.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects
• Provide efficient and robust processes for the manufacture and/or specialized facilities e.g. containment/sterile labs as an expert.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Requirements:
Minimum requirements Ideal Background
Education: Ph.D. or equivalent in Cell Biology / Immunology / Bioprocessing or related sciences and
3 years of relevant experience in process and medium development
Experience:
• Strong fundamental knowledge of cell biology, immunology and cell culture process technology
• Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities e.g., containment/sterile labs
• Hands-on experience with adherent and suspended primary cell cultivation, primary cell separation equipment and respective analytical methods
• A sound knowledge and practical experience in statistics
• GMP experience
