Job Description Summary
#LI-Hybrid
Location: Basel
This role is based in Basel, Switzerland. Novartis is unable to offer
relocation support for this role: please only apply if this location is accessible for you.
The Chemical & Analytical Development (CHAD) serves the interests of Novartis through timely supply of synthetic active pharmaceutical ingredients for clinical and development needs, with responsible process and analytical R&D leading to successful regulatory approval, launch and commercialization. CHAD associates develop and utilize appropriate methodologies to manufacture and analyze bulk pharma chemicals in a safe, efficient, cost-effective, environmentally responsible, and GMP-compliant fashion and through application of expertise in chemistry, engineering and Technical Life Cycle Management.
The Local Supply Center Switzerland (LSC CH) based on the Novartis Campus is looking for an independent, motivated and GMP trained “expert drug supply” / process team coordinator with proven experience in processing and development of chemical pharmaceuticals to ensure the process scale-up with respect to implementation and reliability.
Job Description
Major accountabilities:
Planning, organization and preparation of process equipment, starting materials and other production factors (e.g. in-process controls) that are used for the production of intermediaries/active substances or drug products.
Execution of processes in line with the production guidelines and batch strategy for CHAD. Compliance withGMP-, SOP-, HSE- and other guidelines.
Interacts with the process development teams and influences process development to ensure the process scale-up with respect to implementation and reliability.
Continuous management, advice and service for the process-/manufacturing team assigned regarding the processes and procedures of the daily business.
Complete and independent use of complex equipment and systems.
Enters notifications on the planning and processing of maintenance notifications and orders in SAP-PM. This includes the processes for the corrective maintenance orders, production support, and orders for changes in plants and facilities.
Ensuring or executing training of the process-/manufacturing team for the processes assigned.
Troubleshooting for equipment and processes.
Waste disposal in line with internal and external guidelines (exhaust air, waste water, liquid and solid waste).
Disassembly, cleaning and reassembly of process equipment for production.
Recording of all necessary informationin the batch protocol and instructs the process-/manufacturing team accordingly.
Control of internal batch documentation, including deviation evaluation and preparation for the QA approval.
Active contribution by continuing initiatives for the optimization/improvement of operations and processes in manufacturing, cleaning and maintenance of the pilot plant.
Minimum Requirements:
B.S., apprenticeship or formal education in a logistical, technical or related business area (chemical and pharmaceutical technologist EFZ advantageous)
>3 years of practical experience in chemical /pharmaceutical industry or > 3 years of experience in field of expertise
Basic knowledge about the Drug Development process
Experience in handlingbioconjugates AOC/ oligonucleotides siRNA, ASO / radioligand therapy RLT
Experience with work processes in GMP Zone UC / D / C / A
Experience with isolators (Grade A) in GMP Zone C
Fundamental project management, organization, planning skills
In depth knowledge of Novartis HSE and GMP standards, systems and processes
Knowledge of the LEAN / IQP / Material Flows methodology
Demonstrates problem solving and idea generation skills
Fundamental presentation, leadership and communication skills
Ability to work in interdisciplinary teams
Willing to work 3 shift model (if required), ability to work in a full protection suit
Very good command of German (spoken and written) and basic command ofEnglish (spoken and written) required.
Accessibility and accommodation:
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message
Skills Desired
Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, Production Planning, Supply-Chain Management, Supply Chain Planning, Waterfall Model, Wms (Warehouse Management Systems)
