Job Description Summary

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).

 

Job Description

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.

 

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