Api Manufacturing Science

At Elanco NYSE ELAN - it all starts with animals As a global leader in animal health we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose TM - to advance the health of animals people the planet and our enterprise At Elanco we pride ourselves on fostering a diverse and inclusive work environment We believe that diversity is the driving force behind innovation creativity and overall business success Here you ll be part of a company that values and champions new ways of thinking work with dynamic individuals and acquire new skills and experiences that will propel your career to new heights Making animals lives better makes life better - join our team today Your Role Manufacturing Science Technology MS T Manager - API As the MS T Manager internally known as Technical Services Manufacturing Science - TS MS you will be part of the Elanco External Manufacturing EEM Global API Hub team In this role you will partner with Quality Operations Supply Chain and R D to ensure reliable compliant and cost-effective API manufacturing You will be responsible for supporting established products through their commercial lifecycle providing technical oversight driving process improvements and supporting regulatory submissions Your Responsibilities Serve as the primary technical resource for assigned API manufacturing processes and provide on-site support as needed Lead technology transfer process implementation validation and process improvements with focus on capability compliance cost and regulatory impact Review and author technical and manufacturing documents MBRs eBRs PQRs validation reports change controls regulatory support documents Collaborate cross-functionally to troubleshoot manufacturing issues and support new product commercialization Support API regulatory activities geo-expansion launches and contract manufacturer technical due diligence What You Need to Succeed Minimum Qualifications Education Bachelor s degree in Chemistry or Chemical Engineering or equivalent experience Experience Minimum 5 years in API manufacturing with knowledge of cGMP requirements for drug substance product manufacturing Skills Strong problem-solving stakeholder management analytical and communication skills What Will Give You a Competitive Edge Preferred Qualifications PhD in Chemistry or Chemical Engineering Experience in API process development technology transfer validation and commercialization Knowledge of multiple technology platforms small large molecule material science oral solid dose premixes Experience with continuous improvement deviation management and regulatory requirements EDQM CVM Proficiency in statistical tools JMP Minitab quality document systems e g Veeva and AI-enabled technical tools Additional Information Travel 15-25 to global contract manufacturing sites Location India Mumbai Don t meet every single requirement Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification At Elanco we are dedicated to building a diverse and inclusive work environment If you think you might be a good fit for a role but don t necessarily meet every requirement we encourage you to apply You may be the right candidate for this role or other roles Elanco is an EEO Affirmative Action Employer and does not discriminate on the basis of age race color religion gender sexual orientation gender identity gender expression national origin protected veteran status disability or any other legally protected status