Job Description

Position Purpose: -Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures Major Accountabilities: -Oversight of all production & testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS & T records -MBR review -Support OpEx improvement projects Qualified Person \' Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Responsible for the evaluation of chemical synthesis routes to identify, categorize and control possible mutagenic impurities in active pharmaceutical ingredients (API) and drug products Assessment of potential degradation pathways of APIs in final drug products with the purpose to identify and assess possibility for the formation of potentially mutagenic impurities and ways to prevent this. Participate in cross- functional technical teams as required to deliver on projects. Involved in paper- based assessment of toxicological data for mutagenic, genotoxic and nitrosamines Conduct of feasibility studies for generic API synthesis and synthesis of by-products, degradation products and related substances. Protection of intellectual property in the field of organic synthesis. Utilize scientific expertise and chemical database to generate solutions to problems. Maintaining laboratory logbooks and other project documents in accordance with good documentation practice (data integrity) and HSE requirements. Co-ordination of laboratory work performed by technicians. Creation of relevant instructions, protocols and reports in accordance with scientific and regulatory standards. Other tasks as assigned by the supervisor and tasks based on a specific appointment. Implementation of and adherence to all the instructions and requirements for safe work, environment protection and property protection. Responsibility for personal and professional development, willingness Diversity & Inclusion / EEO Minimum Requirements Sound technical & scientific knowledge of pharmaceutical/ chemical analytics/QC/ equivalent Post-Grad degree (MSc.,) in Chemistry, Pharmacy or other Natural Science degree with proficient program in organic chemistry with 8 years of relevant experience. Excellent theoretical knowledge of Organic chemistry and mechanisms of chemical reactions, advanced knowledge of medicinal chemistry advantageous. Proven track record as a successful synthetic Organic Chemist and other complex synthetic chemistry experience. Priority will be given to candidates with relevant industrial experience in the field of active pharmaceutical ingredient synthesis and PhD from the field of Organic or Medicinal chemistry. Excellent communication, presentation and interpersonal and analytical skills Experience of working closely with the global stakeholders. Project Management skills

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