Souhrn
About the Role
About The Role
Major accountabilities:
Your responsibilities will include, but are not limited to:
- You will be responsible for performing method feasibilities and validate robust analytical methodologies applied to innovative Oligonucleotides/peptide therapeutics. Strong experience in various chromatography techniques is a pre-requisite. Experience in mass spectrometry applied to biological molecules would be an asset.
- Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.
- Accountable for documentation and submission of raw data in an appropriate data system (for e.g., LIMS test activation and results entry).
- Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
- Support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
- Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.).
- Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.
- 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.
- Support internal and external audits and ensure no critical findings within the assigned scope.
- Actively contribute to team and organization goals.
- Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISRM & Novartis Guidelines.
Role Requirements:
Desirable: Ph.D. in Analytical Chemistry or an equivalent qualification with a minimum of 1–3 years of experience, or M. pharm/M.Sc. with at least 8 years of experience within the pharmaceutical industry, specifically in analytical development. Strong expertise in oligonucleotide/peptide analytics
- Profound expertise in liquid chromatography separation techniques such as (RP, IEX and HILIC) is a must.
- Experience in Mass Spectrometry (ranging from mass confirmation to actual quantitative analysis of impurities and sequencing) is preferred
- Contribution to scientific exchange groups within Novartis
- Proven scientific skills in guiding and mentoring colleagues
- Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc.
- GMP experience is a must
- Knowledge in quality principles driving drug development such as GMP.
- Understanding of general regulatory and quality expectations.
- Good scientific background, communication skills including presentation and scientific/technical writing.
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform 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.
