API Manufacturing Science

2 weeks ago

Mumbai, India Elanco Full time

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 (, Veeva), and AI-enabled technical tools. Additional Information: Travel : 15–25% to global contract manufacturing sites. Location : Mumbai or Bangalore, India 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

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