Role Summary
Sr. Director - Process Operations Drug Product MSAT leads the Technical Services / Manufacturing Science (TS/MS) function for the Lilly RTP site, overseeing control strategies for parenteral, device assembly, and packaging operations. This role establishes and implements the organization’s functional agenda aligned with business and strategic plan priorities and is a member of the RTP Site Lead Team.
Responsibilities
- Active member of the RTP Site Lead Team ensuring safety, quality, and operational excellence.
- Provide Health, Safety and Environmental (HSE) and Quality leadership; ensure cGMP compliance and interface 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 objectives to deliver safety, quality, and technical effectiveness and efficiency.
- Oversee manufacturing of RTP products process control and validation strategy across device assembly, packaging, and syringe filling operations.
- Understand the scientific principles for manufacturing parenteral products; lead risk management activities related to products.
- Support delivery of equipment and supporting systems through requirements, design, build, commissioning, qualification, validation, and operation.
- Lead TS/MS technical projects to improve process control, yield, product quality and productivity; implement process changes through the tech agenda.
- Develop, monitor, and respond to statistically based metrics in real-time to assess process variability and capability.
- Develop local TS/MS processes and procedures and ensure accurate instruction sets describe 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 including daily operation, deviation and change management, and reliability improvements.
- Develop and maintain performance metrics; drive continuous improvement and Lean initiatives; participate in RCA and FMEA activities.
- Represent RTP capabilities to global customers, other Lilly sites, and corporate groups.
Qualifications
- Required: At least 10 years of cGMP parenteral manufacturing experience.
- Required: At least 5 years of technical management or leadership experience with cross-functional collaboration.
- Required: Excellent interpersonal, written, and oral communication skills.
- Required: Strong technical aptitude with 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, and aseptic filling.
- Preferred: Equipment qualification and process validation experience; experience with deviation and change management systems.
Education
- Bachelor\'s Degree in chemistry, engineering, or biology
Additional Requirements
- The position is for the Lilly Research Triangle Park site.
- Ability to work 8-hour days – Monday through Friday; ability to work overtime as required.
- Limited travel.