Expert Drug Supply

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.

About the Role

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 with GMP-, 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 information in 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 handling bioconjugates 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 of English (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 E-Mail auf novartis.com ansehen and let us know the nature of your request and your contact information. Please include the job requisition number in your message

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)