Fellow or Senior Fellow Analytical Project Leader, Cell & Gene Therapy job in East Hanover
Vacancy has expired
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
As Analytical Project Leader in Novartis Cell and Gene Technical Development & Manufacturing the job holder will be responsible for the analytical development strategy and the product characterization for CAR T projects. |
Lead analytical development team for cell therapies development projects. Design, plan, supervise and monitor analytical development activities for all assigned projects. Represent Analytics as core member in the technical CMC project team. Contribute to investigations, risk analyses and/or peer reviews; critically evaluate data and conclusions, review reports, and challenge conclusions made by other scientists. Ensure quality, quantity and timelines in all assigned projects and activities with focus on cell product characterization and product analytical and control strategy. Ensure high quality of international registration documents and interact with authorities. Collaborate with Research and/or other functions in Development to facilitate transfer of knowledge and projects. Interface with internal and external partners to lead and monitor outsourcing activities and ensure deliverables according to Novartis standards. Actively participate in global development teams, networks and/or platforms. Lead, facilitate or contribute to optimization of scientific/technical activities and processes within own area of responsibilities.
Reporting to (Recruiting manager): Margit Jeschke, PhD; Global Head Analytical Stewardship & CMC Correlational SciencesPhD or equivalent in Cell Biology / Immunology or related sciences. Five years of relevant hands-on experience in analytical development of cell-based assays is strictly required. Strong knowledge of cell biology, immunology and analytical technology is required. Practical experience in statistics and GMP and a fundamental knowledge of relevant regulatory guidelines (FDA, EMEA, ICH) is highly desirable. Further requirements include team player with strong communication, established presentation and scientific/technical writing skills, good management skills with respect to planning, tracking, priority setting and adherence to project timelines.