Summary
About the Role
Key Responsibilities
- Perform method feasibility studies and validate robust analytical methods for oligonucleotide/peptide therapeutics.
- Plan, execute, and document scientific experiments (method development, validation, transfers, stability, release testing, formulation analytics) as per timelines and quality standards.
- Ensure accurate documentation and submission of raw data in systems such as LIMS.
- Follow and uphold Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
- Support evaluation and interpretation of analytical results, including investigations (SST failures, OOX, deviations, change controls).
- Meet Key Quality Indicators (KQI) and Key Performance Indicators (KPI) for assigned activities.
- Contribute actively to team and organizational goals.
- Work in compliance with SOPs, GMP, GLP, QM, HSE, ISRM, and Novartis guidelines.
Technical Skills Required
- Strong expertise in liquid chromatography techniques (RP, IEX, HILIC).
- Ability to plan, execute, and interpret complex analytical experiments.
- Knowledge of GDP, GLP, GMP, and quality principles in drug development.
- Proficiency with software tools (MS Office, LIMS), and chromatography data systems (e.g., Chromeleon).
- Capability to investigate analytical failures and support troubleshooting.
- Understanding of regulatory and quality expectations.
Qualifications
- Ph.D. in Analytical Chemistry or equivalent with 1–3 years of relevant experience, or
- M.Pharm/M.Sc. with at least 8 years of pharmaceutical analytical development experience.
- Strong background in oligonucleotide and/or peptide analytics.
- Good scientific communication, presentation, and technical writing skills.
Preferred Experience
- Ph.D. in Analytical Chemistry or equivalent with 1–3 years of relevant experience
- Experience in mass spectrometry mass confirmation, impurity quantification, sequencing
- Strong background in oligonucleotide analytical chemistry
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: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
VIDEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
