Associate Director - TSMS Dry External Manufacturing

Associate Director Technical Services / Manufacturing Science (TS / MS) Dry Products External Manufacturing (Dry EM)

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.

The Associate Director Technical Services / Manufacturing Science (TS / MS) Dry Products External Manufacturing (Dry EM) is responsible for managing the activities of TS / MS personnel supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate / industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and multiple global contract manufacturers to deliver on technical 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 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 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 risk 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.

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Additional Information :

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $191,400. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and / or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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