Summary Collaborate with Site MS T and multifunctional technical operations teams within the Large Molecules platform to ensure seamless communication and effective problem-solving Maintain oversight of process and validation activities including preparation and updates of risk assessments and documentation for validation OPV CPV change control and technology transfer Drive compliance and operational excellence by supporting cross-functional initiatives and ensuring timely execution of all technical deliverables About the Role Major accountabilities Chemical Biochemical and or Biotechnological Expertise Biotechnological Processes Strong understanding of fermentation and cell cultivation techniques Purification Techniques Skilled in filtration and chromatography methods Biochemical Processes Basic knowledge of biochemical principles Risk Assessments Experience in preparing Nitrosamine assessments raw material risk evaluations and declarations for residual solvents and elemental impurities Physio-Chemical Properties Good understanding of chemical and buffer properties e g buffer capacity stability Analytical Methods Familiar with basic techniques such as pH conductivity and density measurements Essential Requirements Technical Expertise Solid understanding of biotechnological processes e g fermentation cell cultivation techniques Skilled in purification techniques e g filtration chromatography Basic knowledge of biochemical processes Experience in Nitrosamine preparation raw material risk assessments and declarations for residual solvents and elemental impurities Good understanding of physio-chemical properties of chemicals and buffers e g buffer capacity stability Familiar with basic analytical methods e g pH conductivity density Manufacturing Excellence Desired to be familiar with Manufacturing Process Transfer Contribute to process improvement and optimization for product transfers Change Control Strong understanding of global and local change control processes able to advise on strategy Align cross-functional teams including Regulatory on change control plans and site impact Prepare and present change request plans for endorsement at the Change Review Board CRB Open and manage change requests assign impact assessments and oversee lifecycle of CRs Track and report implementation status with cross-functional teams Maintain accurate documentation version control and compliance with cGMP and regulatory standards Training Contribute to process improvement and optimization for product transfers Ideal Background Requirements Education Bachelor s in Pharmacy Pharmaceutical Technology Chemical Engineering Biotechnology Chemistry or equivalent MSc MS preferred Experience Minimum 8 years in MS T process validation or large molecule drug substance manufacturing Familiarity with regulatory guidance on validation product filing and post-approval changes Proven project management experience in cross-functional multi-site environments Expertise in reviewing and writing technical reports Strong communication presentation and interpersonal skills Proficient in English oral and written Desirable Requirements Quality Accuracy Right First Time Timeliness Deviations Escalations Why Novartis Our purpose is to reimagine medicine to improve and extend people s 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 https www novartis com about strategy people-and-culture You ll receive You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook https www novartis com careers benefits-rewards 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 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 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 Join our Novartis Network Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up https talentnetwork novartis com network Benefits and Rewards Read our handbook to learn about all the ways we ll help you thrive personally and professionally https www novartis com careers benefits-rewards Division Operations Business Unit Production Manufacturing Location India Site Hyderabad Office Company Legal Entity IN10 FCRS IN010 Novartis Healthcare Private Limited Functional Area Technical Operations Job Type Full time Employment Type Regular Shift Work No 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 Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve