Job Description Summary
As Senior Process Expert CGT you will act as subject matter expert for all process-specific issues to ensure execution of processes on time, continuously improving in quality and productivity, performed in compliance to cGMP, SOPs and applicable guidelines and functional standards. Supports processes and standards to maintain and improve existing and to implement new innovative concepts and strategies.
Why join Cell & Gene Therapy?
Novartis is pioneering the way in the class of cell and gene treatment and has developed the first CAR-T cell therapy approved for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukaemia (ALL). The patient is at the center of the process for CAR-T cell therapy. The process begins with the patient at autologous T-cell collection and ends with the patient at infusion.
Key Responsibilities:
1. Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
2. Responsible for maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment).
3. Support steward for assessment of technical changes and process changes (task manager ACC/PCC).
4. Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs.
5. Support the execution of process validations and qualifications, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
6. Perform first line evaluation of product and process related issues, perform root-cause investigations (uncritical, major and critical deviations, complaints, OOS, OOE) and implement effective CAPAs.
7. Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
8. Support technology trainings and education programs for production operators and others.
9. Act as Subject Matter Expert for Audits.
Minimum Requirements:
1. Minimum BSc. or MSc. in Biotechnology, Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree with some years of experience in a technical process support role on the shopfloor of GMP manufacturing.
2. Or: PhD in Biotechnology, Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree with less experience in a technical process support role on the shopfloor of GMP manufacturing.
3. Fluent English language skills (written and oral).
4. German language skills are desirable.
5. Experience working in a GMP environment.
6. Knowledge of Cell & Gene topics.
7. Root cause investigation skills.
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