Novartis Services Incorporated Senior Scientist, Clinical Research and Process Development in East Hanover, New Jersey
Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader. Manage technical lab/plant activities. Can also assume role as project leader.MAJOR RESPONSIBILITIES
* Meet quality, quantity and timelines in all assigned projects.
* Design, plan and perform scientific experiments/plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team member (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, write reports).
* Provide scientific and technical guidance. Coach team members as needed.
* 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 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.
* 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 URS if applicable.
* Report and present scientific/technical results internally and contribute to publications, presentations and patents.
* Contribute to maintenance of infrastructure/equipment.
* Actively contributes to team goals.
* Off-hours and weekend support required on an as needed basis.
Education: BS/BA required. Advanced degree in a scientific or relevant discipline (Immunology, Cell Biology, Immunotherapy, Cell/Gene Therapy) preferred.Languages: Fluent in speaking / writing in English
* Successfully demonstrated several years (minimum of 3 years) of directly related experience as scientist or Ph.D. (0 years' experience).
* Broad scientific or technical knowledge in a specific area.
* Adequate understanding of development processes in own function.
* Experience in Immunology, Cell Therapy, cell biology, biomarker identification, clinical research, cell isolation and maintenance preferred.
* Understanding of CAR-T manufacturing and development process scale up and scale down preferred.
* Advanced knowledge of laboratory and/or technical tools.
* Good knowledge of software and computer tools.
* Proficient in literature searches.
* Good presentation skills and scientific/technical writing skills.
* Good communication skills, basic coaching skills.
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.