Associate Director - TSMS Dry External Manufacturing

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The Associate Director – Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing (Dry EM) is responsible for managing the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical and engineering staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization, process optimizations and engineering activities oversight.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation and engineering practices. The position requires working cross-functionally within sites, network, commercialization teams, and multiple global contract manufacturers to deliver on technical /engineering objectives, specific product business plan, and quality objectives.

Key Objectives/Deliverables:

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Performance management and development of staff.
• Partner within TS/MS , ENG and across functional disciplines to influence and implement the technical agenda, site business plan objectives, functional objectives, and GMP Quality Plan objectives
• Ensure appropriate technical and Engineering oversight and stewardship of oral solid dose form manufacturing and packaging including drug product intermediates (e.g. spray dried dispersions/amorphous solid dispersions).
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
• Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
• Ensure adequate oversight and technical excellence for investigations and complaints including CAPA and monitoring improvement.
• Ensure adequate oversight for technical projects/technical agenda to improve process control, capacity, yield, quality.
• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Build relationships external to Lilly to create benchmarks opportunities and identify best practices.
• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.
• Escalate to Sr. Leaders in a timely fashion risks to supply, manufacturing issues major deviations, critical complaints or safety and cybersecurity issues.
• Lead implementation and execution of activities aligned with emerging need related to process improvement, control strategy or new regulation and ensure any emerging need is incorporated into the CMs technical agenda.

General:

• Contribute to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.
• Contribute to Business Plan and Strategic Plan processes
• Serve as cross-functional member on DryEM Lead Team
• Ensure JPT objectives and priorities are delivered and issues escalated.
• Support financial planning and reporting for Dry EM.

Relationships:

• TS/MS, ENG functions at other Lilly locations (e.g. Lilly plant sites and central TS/MS).
• All relevant functions within external manufacturers.
• Internal Manufacturing Nodes (PR01, Alcobendas)
• Dry EM team.
• API-EM group.
• External Manufacturing Organizations.
• Lilly GQAAC
• Lilly Global Supply Chain functions.
• Lilly Teach @ Lilly functions.
• Lilly Geneva and IHL Kinsale (If…