Summary
You will be part of the chemical and analytical development team at our site in Genome Valley and report to the local team leader. 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
About the Role
Key Responsibilities
- Working as a Process Chemist in the External Partner Management (EPM) unit of Chemical and Analytical development (CHAD) group located in Hyderabad, India
- Guiding external partners to plan, prepare, complete and document chemical manufacturing within CDMO facilities meeting regulatory and health authorities' expectations
- Supervising GMP manufacturing activities such as master batch record handling, deviation handling and change control management
- Support external manufacture to ensure timely delivery of drug substance and reviewing technical and GPM-relevant documents
- Providing scientific guidance to external manufacturing teams, supporting daily business, troubleshooting etc.
- 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 Substance project team discussion (internal and external) and contribute to overall strategies and goals of chemical development projects
- Supporting the set-up of data bases and document flow process within the EPM unit
- Contribution to scientific exchange groups within Novartis and externally and evaluation, selection and onboarding process of new external partners
Minimum Requirements
- PhD/ Masters (M.Sc.) in synthetic organic chemistry with 8-12 years of hands-on scale up experience in the pharmaceutical industry in chemical development and GMP manufacturing (development/commercial)
- Proven hands-on experience in working in a GMP manufacturing environment and plants
- Excellent knowledge of manufacturing plants & facilities and related documentations (like tech transfer documents, BMR, deviation management, CAPA, etc)
- Successfully demonstrated expertise in scale up of drug substance from lab to plant
- Proficient English (oral and written).
- Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility are key attitudes
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: Learn about all the ways we’ll help you thrive personally and professionally.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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.
