Expert Science & Technology - (Oligonucleotides/Peptide Therapeutics)

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