Job Description

400! This is the number of associates in Global Analytical R&D, across 4 countries, working tirelessly on innovative and patient centric medicines. As part of this group, you design, plan and/or perform scientific/technical studies. By bridging analytical science to the clinical performance, you will drive the transformation of our molecules into medicines that improve and extend patient’s lives. The position is based in the Genome Valley, Hyderabad, within the Technical Research and Development Organization (TRD) of Global Drug Development (GDD).

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

Skills Desired

Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model