Job Description

We are looking for a highly motivated Process Chemist to manage early phase projects from GLP tox batches up to first-in-human API deliveries. In this role you will closely collaborate with CDMO’s in India but also work together with colleagues from other Novartis internal functions and sites.

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

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

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