API Manufacturing Science & Technology Manager

Role Overview: At Elanco, you will be the Manufacturing Science & Technology (MS&T) Manager for API, playing a crucial role in ensuring reliable, compliant, and cost-effective API manufacturing. You will collaborate with various departments to support established products, drive process improvements, and facilitate regulatory submissions. Your expertise will be instrumental in enhancing animal health and advancing the company's mission of Food and Companionship Enriching Life. Key Responsibilities: - Serve as the primary technical resource for assigned API manufacturing processes, offering on-site support as required. - Lead technology transfer, process implementation, validation, and improvements focusing on capability, compliance, cost, and regulatory impact. - Review and author technical and manufacturing documents such as MBRs/eBRs, PQRs, validation reports, change controls, and regulatory support documents. - Collaborate cross-functionally to troubleshoot manufacturing issues and aid in new product commercialization. - Support API regulatory activities, geo-expansion launches, and conduct technical due diligence for contract manufacturers. Qualifications Required: - Education: Bachelors 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. Preferred Qualifications for Competitive Edge: - 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. (Note: Additional details about the company were not included in the provided job description),