Associate Director - Technical Services​/Manufacturing Science

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly unites caring with discovery to create medicines that make life better for people around the world. Lilly is a fortune 500 company that has been in operation for over 140 years. We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designed and built a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina. This is an exciting opportunity to help run a state of the art manufacturing facility.

The Technical Services/Manufacturing Science (TS/MS) Associate Director is responsible for the staffing, training, and leadership of the TS/MS group specifically for parenteral operations (formulation, filling, visual inspection). The TS/MS group provides technical leadership for syringe filling, device assembly, and packaging operations for commercially manufactured products targeted for transfer to the RTP site.

The Associate Director will be responsible for supporting the day-to-day TS/MS activities as well as planning for the 3-6-month horizon. The TS/MS Associate Director is expected to lead by example and provide coaching to others in the areas of safety, quality, technical capability, and continuous improvement.

** Key Objectives / Deliverables:*
* + Understand the scientific principles required for manufacturing parenteral drug products, device assembly and packaging, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.

+ Support Site Leadership to build a diverse and capable TS/MS organization, supporting the areas of device assembly, packaging, and parenteral operations.

+ Deliver equipment, lines, and supporting systems through technology transfer, process validation, and control strategy development.

+ Provide leadership and develop objectives to deliver business plan goals as it relates to safety, quality, and process effectiveness and efficiency.

+ Determine staffing and resource needs to support site TS/MS requirements.

+ Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.

+ Provide technical guidance to the TS/MS group.

+ Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives:
Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).

+ Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.

+ Understand and influence the manufacturing control strategy for the various operational areas.

+ Manage external contracts/resources and project management resources, as needed.

+ Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.

+ Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.

+ Drive control, capability, productivity, and continuous improvement for the process.

+ Support and/or lead TS/MS technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity.

+ Serve as technical interface external to the RTP site.

+ Work within or lead cross-functional teams in positive fashion to implement TS/MS objectives and deliver…