Associate Director - TSMS Dry External Manufacturing

We are seeking an Associate Director – Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing (Dry EM) to manage TS/MS and engineering personnel supporting oversight of external manufacture of dry products. The role involves coaching staff, prioritizing and staffing routine production support, implementing technical projects, technical transfers, commercialization, process optimizations, and engineering activities oversight. The Associate Director must possess knowledge of cGMPs and relevant regulatory, validation, and engineering standards, and work cross‑functionally across sites, the network, commercialization teams, and global contract manufacturers to meet technical goals and quality objectives.

• Ensure technical review and approval of 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 cross‑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 benchmark 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 risks to supply, manufacturing issues, major deviations, critical complaints or safety and cybersecurity issues to senior leaders in a timely fashion.
• Lead implementation and execution of activities aligned with emerging needs related to process improvement, control strategy or new regulation and ensure any emerging need is incorporated into the CMs technical agenda.

• 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.

• 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 required).
• Lilly External Manufacturing Support Teams.

• Bachelor's Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or another related field.
• 8+ years’ experience in Dry Products/Oral Solid Dose pharmaceutical manufacturing environment in any of the following associated disciplines:…