Associate Director TS/MS DP External Manufacturing

Location: Indianapolis
Posted on: June 23, 2025

Job Description:

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. Overview: This role leads the Technical Services (TS/MS) Primary Loop team, providing technical oversight for all activities supporting external manufacturing in alignment with Global Contract Manufacturing Standards. The position ensures technical excellence, compliance, and reliable day-to-day operations in the manufacturing and supply of medicines. Key Responsibilities Provide technical oversight to ensure reliable, efficient manufacturing at Contract Manufacturers (CMs). Develop and maintain robust control strategies for manufacturing, packaging, and distribution in line with Lilly standards. Ensure validated processes and critical parameters align with regulatory submissions throughout the product lifecycle. Maintain compliance with cGMPs, regulatory commitments, and Lilly Functional Standards; ensure inspection readiness. Monitor product quality using metrics, CAPAs, and performance systems. Build strong CM relationships to align on goals and expectations. Lead validation strategy, protocol approval, execution, and reporting. Manage change controls and assess regulatory/process impacts. Investigate deviations, identify root causes, and implement corrective actions. Ensure timely process reviews and documentation updates. Maintain compliant external manufacturing documentation (e.g., Quality Agreements, MRDs). Benchmark industry best practices to drive continuous improvement. Oversee execution of technical agendas aligned with business plans and standards. Escalate supply risks, major deviations, and safety/cybersecurity concerns. Implement process improvements, control strategies, and regulatory updates at CMs. Support CM selection by evaluating technical capabilities and advising on sourcing. Contribute to DPEM governance and business plan execution. Collaborate with internal stakeholders (e.g., TS/MS Central, IDM, Global Packaging). Partner with JPTLs, Quality Managers, and Secondary Loop to achieve TS/MS objectives. People Leadership Ensure adequate staffing to support both Joint Process Team and functional agendas. Lead performance management processes, including goal setting, reviews, coaching, and feedback. Promote diversity in recruitment and development, lead recognition, merit, and promotion decisions. Support technical talent assessment and succession planning. Recruit and onboard new team members effectively. Foster knowledge sharing within the team and with internal/external partners (Operations, QA, Supply Chain, etc.). Develop and grow the technical capabilities of the Primary Loop team to meet DPEM business needs. Qualifications Required: Bachelor’s degree in Pharmacy, Chemistry, Engineering, or STEM related field. Minimum 5 years of experience in: Pharmaceutical manufacturing, technical services, or quality. Managing a team Supporting a CMO Preferred: Prior leadership experience. Experience with packaging and/or assembly processes. Familiarity with basic statistical tools. Regulatory experience. Established internal and external technical/quality networks. Strong understanding of cGMPs and drug product manufacturing. Excellent communication skills, with attention to detail in documentation. High technical curiosity, critical thinking, and learning agility. Strong leadership, interpersonal, and teamwork skills. Data-driven decision-making and scientific reasoning. Additional Information: Ability to work in a virtual, complex, and culturally diverse environment. Willingness to travel (up to 40%). Role located in U.S. Relocation package available 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) 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. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. 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 - $173,800 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. WeAreLilly

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