Resumé
About the Role
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.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
