API Manufacturing Science & Technology Manager

As a Manufacturing Science & Technology (MS&T) Manager for API at Elanco, you will be an integral part of the Elanco External Manufacturing (EEM) Global API Hub team. Your primary responsibility will be to collaborate with Quality, Operations, Supply Chain, and R&D to ensure consistent, compliant, and cost-effective API manufacturing processes. Your role involves supporting existing products throughout their commercial lifecycle, offering technical expertise, driving process enhancements, and aiding in regulatory submissions. Your duties will include serving as the key technical contact for designated API manufacturing processes, leading technology transfers, process implementations, validations, and improvements with a focus on capability, compliance, cost, and regulatory considerations. Additionally, you will be involved in reviewing and creating technical and manufacturing documents, collaborating across departments to resolve manufacturing challenges, and assisting in the introduction of new products to the market. Minimum qualifications for this role include a Bachelor's degree in Chemistry or Chemical Engineering, or relevant experience, along with a minimum of 5 years of experience in API manufacturing, encompassing a solid understanding of cGMP requirements for drug substance and product manufacturing. Proficiency in problem-solving, stakeholder management, analytical thinking, and effective communication skills are essential for success in this position. Preferred qualifications that will give you a competitive edge include a PhD in Chemistry or Chemical Engineering, experience in API process development, technology transfer, validation, and commercialization. Knowledge of various technology platforms, such as small/large molecules, material science, oral solid dose, and premixes, is advantageous. Familiarity with continuous improvement practices, deviation management, and regulatory requirements, along with proficiency in statistical tools, quality document systems, and AI-enabled technical tools, will further enhance your candidacy. This role may require up to 1525% travel to global contract manufacturing sites, and the position is based in Mumbai, India. Elanco values diversity and inclusivity in the workplace and encourages candidates who may not meet all requirements but believe they can contribute effectively to apply for this role or other opportunities within the organization. Join Elanco today and be a part of a team dedicated to improving the lives of animals and enriching life overall.,