Fellow Scientist - Media Development
Morris Plains (Morris County)
Job description
Job Description
PURPOSE
Establish, manage and own T-cell media development/characterization and transfer for current and future Cell & Gene Therapy projects.
RESPONSIBILITIES
• Contribute and/or lead interdisciplinary media development work for advanced therapy projects in Cell and Gene Therapies.
• Interface with external partners to lead and monitor outsourcing activities and ensure deliverables according to Novartis standards.
• Coach team members and contribute to overall Cell and Gene process development strategies and goals.
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level.
• Ensure the quality and timelines in all assigned projects, networks and/or platforms.
• Design, plan and perform scientific experiments 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, data analysis, and study evaluation.
• Optimize existing methods (lab or plant) and develop more efficient ones.
• 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.
• Give guidance to team members and work according to appropriate SOP’s, GLP, GMP, OQM, HSE, ISEC and Novartis guidelines.
• Utilize aseptic techniques for T cell culture.
• Evaluate new lab and/or manufacturing equipment.
• Contribute to external 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.
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.
Desired profile
Minimum requirements
Education: MS or equivalent in Cell Biology / Immunology / Bioprocessing or related sciences and 3 years of relevant experience in process and medium development
Languages: Fluent in speaking / writing in English
Experience:
• Expertise in cell culture media development
• 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