Job Description Summary

As part of the Global Drug Development (GDD) team, this role is essential in ensuring the development of highest quality small molecule drug substances throughout the life cycle of each project, required to support clinical trials.

 

Job Description

Key Responsibilities

• Working as an Analytical Expert in the External Partner Management (EPM) unit of Chemical and Analytical development (CHAD) in their new group in Hyderabad. 
• Guiding external partners to develop analytical methods to control and monitor the performance of synthetic drug substance manufacturing processes, with a focus on analytical separation sciences (e.g. HPLC, LC-MS etc.).
• Supervising GMP activities such as method validation, specification setting, release testing, deviation handling and change control management
• Helping to define the overall analytical control strategy for the manufacture and timely delivery of drug substances
• Providing scientific guidance to external analytical teams, supporting daily business, troubleshooting etc. Contribution to scientific exchange groups within Novartis and externally. 
• Supporting CMC document writing and regulatory submissions.
• Actively managing interactions between internal and external partners to ensure a constructive and well-functioning collaboration
• Participation in technical Drug Substances project teams (internal and external) and contribute to overall strategies and goals of chemical development projects. Supporting the setting up of databases and document flow process within the EPM unit.
• Contributing to evaluation, selection and onboarding process of new external partners. Reviewing technical and GPM-relevant documents

Minimum Requirements

• Masters/PhD in analytical chemistry or equivalent and a minimum 8-10 years’ experience in the pharmaceutical industry in analytical development
• Recognized achievements in the development of new analytical methods: main focus on separation sciences, e.g. HPLC, LC/MS, GC as well as physio-chemical methods (Karl Fischer water determination, titrations).
• Successfully demonstrated expertise in a specific scientific/technical area
• Proven experience in a GMP analytical environment. Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility are key attitudes 
• Excellent knowledge of laboratory and/or technical tools. Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software (e.g. Chromeleon) etc.
   

 

Skills Desired

Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model