Advisor – Technical Services

Role Summary

Advisor – Technical Services within the Bioproduct Research and Development (BR&D) organization. Lead downstream technical services and Manufacturing Science for clinical trial bulk drug substance production, driving technology transfer, and providing mentorship to the downstream team to ensure robust manufacturing performance and continuous improvement.

Responsibilities

• Lead and deliver downstream process technology transfer for Bulk DS into clinical manufacturing
• Input and author manufacturing master production records compliant with cGMP and PRD Quality System; review of executed batch records where applicable
• Ensure robust execution of DS batches with adherence to quality and regulatory standards
• Actively oversee process and equipment performance, troubleshooting, optimization, and real-time data monitoring
• Serve as primary technical resource for downstream operations in the DS CT manufacturing pilot plant
• Drive alignment between process development and manufacturing execution
• Lead plant improvement projects focused on safety, efficiency, reliability, plant digitalization, and scalability of downstream operations
• Engage with HSE, Quality Assurance, Tech Services, Development, Operations, FUME/CQ, Automation, Engineering, Maintenance, Environmental Monitoring, and Manufacturing to resolve complex technical challenges
• Coach and mentor team, fostering technical growth and professional development
• Promote a culture of collaboration, accountability, and operational excellence

Qualifications

• Required: PhD in Chemical Engineering, Chemistry, Biochemistry, Biology, or related discipline with at least 3 years hands-on purification experience; OR MS with at least 5 years; OR BS with at least 8 years
• Required: Proficiency with UNICORN software for chromatography process control and data analysis
• Required: Demonstrated ability to lead cross-functional projects and mentor technical staff
• Required: Excellent communication and leadership skills, with the ability to influence and drive change
• Preferred: Understanding of cGMP requirements and regulatory compliance for clinical manufacturing
• Preferred: Experience with scale-up of biopharmaceutical purification operations
• Preferred: Familiarity with automation systems and process control strategies
• Preferred: Understanding of computer system validation and equipment qualification
• Preferred: Familiarity with digital solutions for GMP DS manufacturing

Education

Additional Requirements

• Position located in Indianapolis, IN at the Lilly Technology Center North
• 8-hour days with flexibility to support activities during shutdowns, weekends, and outside core hours
• Physical Demands/Travel: Office and manufacturing environment; reasonable accommodations may be provided; travel as required to support manufacturing and cross-functional activities