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Eli Lilly is establishing a $1B+ Manufacturing and Quality Technical Hub in Hyderabad to oversee contract manufacturing of starting materials, intermediates, and API manufacturing in India. This role is a senior process engineering position within that hub, providing technical leadership and hands-on engineering support for the design, optimization, and scale-up of laboratory-based processes for robust manufacturing of drug substances and drug products.
Key Responsibilities:
Technical Development & Support: Partner with TS/MS scientists in the US and Ireland to design, develop, and refine laboratory-scale processes. Establish, maintain, and optimize unit operations in the process development lab (chromatography, filtration, mixing, crystallization, upstream/downstream studies, formulation experiments). Develop scale-down models that accurately represent full-scale operations and use them to support process characterization, robustness studies, and troubleshooting. Conduct hands-on laboratory experimentation, data analysis, and technical reporting to support key development and manufacturing decisions.
Process Optimization & Technology Transfer: Support technology transfer activities by preparing process documentation, generating process parameters, and enabling smooth movement of processes from lab to pilot or manufacturing scale. Support technical process issues and implement long-term improvements informed by lab experimentation. Apply engineering fundamentals and first-principles thinking to develop innovative solutions, improve process understanding, and enhance robustness.
Laboratory Operations & Safety: Oversee safe operation of laboratory equipment and ensure compliance with EH&S expectations. Support equipment specification, procurement, installation, and qualification for lab-scale systems. Maintain high-quality documentation practices, including experimental protocols, batch records, and engineering analyses.
Cross-Functional Collaboration: Collaborate closely with automation, analytical, mechanical, and instrumentation engineering groups to introduce new tools, models, and technologies. Partner with Quality, TS/MS, and manufacturing to align development activities with long-term production needs. Provide mentoring, training, and knowledge sharing to laboratory personnel and junior engineers.
Innovation & External Engagement: Stay current with industry trends, emerging technologies, and best practices in process development. Leverage external collaborations, vendor interactions, and professional networks to strengthen internal capabilities.
Travel: Some domestic and international travel (less than 5%) may be required.
Requirements:
- Ph.D. in Biochemistry, Chemistry, Chemical Engineering, or related fields, OR Ph.D. + Post Doc in Chemistry (focusing on Peptide chemistry) with 12+ years of experience
- Minimum 5–8 years of experience in process development, lab-scale engineering, or manufacturing support in pharmaceutical, biotechnology, or similar industries
- Experience with process modeling software (e.g., Aspen, MATLAB, statistical design tools)
- Working knowledge of GMP expectations and laboratory quality systems
- Experience with 3D modeling tools (e.g., SolidWorks) for equipment design or fixture development
- Demonstrated experience in technology transfer and scale-up/scale-down in laboratory-scale unit operations relevant to the role (chromatography, TFF, bioreactors, mixing systems, filtration and drying technologies)
- Strong analytical and PC skills, including data modeling, statistical methods, and ability to interpret experimental results
- Excellent written and verbal communication skills
- Strong problem-solving abilities and ability to work independently with minimal direction
