摘要
Role Purpose:
We are looking for a highly motivated Expert in Science & Technology to support Analytical Research & Development (ARD). ARD sits within the Global Technical R&D department of Development and plays an essential role in the characterization and analysis of Small Molecule Drug Substances and Drug Products from the time they leave the discovery laboratory until they are transferred to Commercial Production. The role will be part of the Small Molecules GMP Analytics Team with focus on small molecules and Radioligand Therapy.
About the Role
Major accountabilities:
- Independently plan, organize, execute, and document scientific experiments (e.g., stability/ release testing, validations, etc.) according to the agreed timelines and appropriate quality standards.
- Execute experiments using state of the art analytical instruments e.g. HPLC
- Perform Cleaning validation/verification experiments
- Accountable for documentation and submission of raw data in appropriate data system (e.g., GLIMS eLN ).
- Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
- Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables /samples/column/ glassware management etc.).
- Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
- Support management of TRD planning tool (PLATON)
- Train and coach associate scientists, technicians, temporary employees and employees under training / education
- Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
- Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities.
- Work according to appropriate SOPs, GMP, HSE, ISRM and Novartis Guidelines
Minimum Requirements:
- Bachelors/Masters in Life Science (e.g., analytical / organic chemistry /pharmacy / pharmaceutical development) or equivalent
- 3+ years of related experience in a GMP environment
- Experience with HPLC, Cleaning validation/verification
- Experience working with eLN
- Experience working with digital tools, VBA
- Understanding of general regulatory and quality expectations.
- Good scientific background, communication skills including presentation and scientific/technical writing.
Languages :
- Fluent English (Oral and written)
- German as a plus
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 [email protected] 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? https://www.novartis.com/about/strategy/people-and-culture
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