Sr. Director - Technical Services/Manufacturing Sciences

Role Summary

Sr. Director - Technical Services/Manufacturing Sciences responsible for providing leadership to the TS/MS function at the RTP site, implementing and overseeing control strategies for parenteral, device assembly, and packaging operations, and aligning the function with business and strategic plan priorities. Member of the RTP Site Lead Team.

Responsibilities

• Active member of the RTP Site Lead Team ensuring safety, quality, and operational excellence.
• Provide HSE and Quality leadership; ensure cGMP compliance; interact with Regulatory Agencies during site inspections.
• Support Site Leadership to build a diverse and capable site organization; talent management, development, and retention.
• Provide site functional leadership and develop objectives to deliver safety, quality, and technical effectiveness and efficiency.
• Oversee manufacturing of RTP products process control and validation strategy for device assembly, packaging, and syringe filling operations.
• Understand principles for manufacturing parenteral drug products; lead risk management activities.
• Support equipment and supporting systems through requirements, design, build, commissioning, qualification, validation, and operation.
• Lead TSMS technical projects to improve process control, yield, product quality, and productivity; implement changes through the tech agenda.
• Develop metrics to assess process variability and capability; react to real-time data.
• Develop local TS/MS processes and procedures; ensure accurate instruction sets describing processes and control strategies.
• Own Site Validation Plan and lead site validation efforts; own Site Sterility Assurance Plan.
• Drive stability strategy for RTP products; align function to meet production throughput goals; manage deviations, changes, and reliability.
• Develop and maintain performance metrics; implement Lean principles and value stream mapping.
• Collaborate with Engineering, Quality, and Operations to achieve operational results.
• Participate in strategies for Continuous Improvement, RCA, and FMEA.
• Represent RTP capabilities to global customers, other Lilly sites, and corporate groups.

Qualifications

• Required: At least 10 years cGMP parenteral manufacturing experience.
• Required: At least 5 years technical management or leadership experience with cross-functional teams.
• Required: Excellent interpersonal, written, and oral communication skills.
• Required: Strong technical aptitude; ability to train and mentor others.
• Required: Ability to handle multiple competing priorities.
• Preferred: Demonstrated regulatory inspection experience.
• Preferred: Experience with combination products, device assembly, pharmaceutical packaging, aseptic filling and drug product formulation.
• Preferred: Equipment qualification and process validation experience; deviation and change management system experience.

Skills

• Leadership and people development
• Technical project management
• Process control and validation
• Quality systems and cGMP compliance
• Lean manufacturing and continuous improvement
• Data-driven decision making and metrics development
• Cross-functional collaboration

Education

• Bachelor's Degree in chemistry, engineering, or biology

Additional Requirements

• The position is located at the Lilly Research Triangle Park site.
• Ability to work 8-hour days Monday through Friday; overtime as required.
• Limited travel.