Job Description

Summary 5,The typical number of projects you will participate in as the new EPM Specialist based at Novartis Hyderabad site. 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.Major accountabilities:xc2xb7 Owning and leading process improvement activities related to externalized process R&Dxc2xb7 Supporting oversight/documentation/workflows related to externalized business (non-GMP/GMP).xc2xb7 Managing data and readouts related to externalized activities (compilation of relevant KPIs for regular evaluations with external partners)xc2xb7 Supporting CMC document writing and regulatory submissionsxc2xb7 Contributing to evaluation, selection and onboarding process of new external partners.xc2xb7 Actively managing interactions between internal and external partners to ensure a constructive and well-functioning collaboration.xc2xb7 Participating in scientific/technical exchange with internal stakeholders and external partners.xc2xb7 Supervising GMP activities such as master batch record and executed batch record handling, deviation handling and change control management.xc2xb7 Support external manufacture and timely delivery of drug substance.xc2xb7 Reviewing technical and GPM-relevant documents.xc2xb7 Identifies and supports continuous improvement initiatives related to external partners and internal processes.xc2xb7 Supporting/leading set up of data bases and document flow process within the EPM unit.xc2xb7 Owning, developing and maintaining team SharePoint.What youll bring to the role:xc2xb7 Desirable: PhD/MSc in chemistry, chemical engineering or equivalent and a minimum 3 years experience in the pharmaceutical industry in chemical development and/or commercial.xc2xb7 Proven experience in a GMP environment (equipment/facilities, manufacturing, deviation handling, change control, documentation etc.)xc2xb7 Successfully demonstrated expertise in a specific scientific/technical area.xc2xb7 Fluent English (oral and written).xc2xb7 Strong coordination and communication skills, collaborative spirit, self-driven attitude, high level of learning agility are key attitudes.xc2xb7 Excellent knowledge of data management and software/tools such as Office package (e.g. Excel, SharePoint, MSTeams), SAP, planning tools etc.
Personal inclination for IT solutions and data management is a plus.xc2xb7 Experience in operational excellence and Six Sigma certification is a plus.xc2xb7 Experience and knowledge in procurement of API, intermediates, raw materials and services incl. management of RFPs and RFIs is a plus.Why Novartis:
Our purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:Youll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.Commitment to Diversity and Inclusion:
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 diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your messageJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: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

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