377296BR Job ID: 377296BR Job Description: 28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently. Your key responsibilities: Your responsibilities include, but not limited to: • Represent the technical Interface to external supplier to ensure robust product process capability. • Responsible for process validation oversight & execution at the external supplier. • Ensure successful and well-documented transfers and launches of products with external manufacturing involvement. • Assess impact of technical changes, technical feasibility and scope / design of technical batches. • Lead or support root cause investigation of product and process failures. • Contribute to the registration strategy and ensure alignment of (regulatory) timelines. • MS&T support for technical development of biopharmaceuticals. Responsible for the technical lifecycle management (e.g.: CPV, process improvements, etc.) together with the CMO. nnnn Position Title: Senior Technical Manager – Drug Product Minimum requirements: What you will bring to the role: • University degree in pharmacy, chemistry or other equivalent natural science degree. • 10 years of relevant in biopharmaceutical manufacturing, solid understanding of biotechnology (microbials and/or mammalians; USP & DSP). • Good Understanding of aseptic manufacturing of sterile, parenteral doses form and associated guidelines. Expertise in Drug Product manufacturing with large molecule API. • Experience in Drug Product development is preferred, expertise in equipment qualification including qualification of visual inspection is a plus • Demonstrated leadership and accomplishments in a global/matrix environment, strong project management experience and problem solving skills. • Technical expertise in manufacturing process science and drug substance development is a plus. English – fluent written and spoken. Intermediate command of German beneficial. Why Novartis? 236 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Join 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: https://talentnetwork.novartis.com/network Job Type: Full Time Country: India Work Location: Hyderabad, AP Functional Area: Technical Operations Division: Operations Business Unit: SUPPLY CHAIN Employment Type: Regular Company/Legal Entity: Nov Hltcr Shared Services Ind Commitment to Diversity & Inclusion:: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Shift Work: No Early Talent: No
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