Job Vacancy Hyderabad, Telangana, India Position Expert Science & Technology – (Oligonucleotides/Peptide Therapeutics) at Novartis

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.

Minimum 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 an asset.

• Contribution to scientific exchange groups within Novartis
• 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.

Functional Breadth.

• Operations Management and Execution.
• Collaborating across boundaries.

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