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.

Organization Overview:
The Associate Director – Technical Services/Manufacturing Science (TS/MS) Sterility Assurance Technology (SAT) is responsible for leading a team and understanding elements of parenteral manufacturing, including the technical elements relative to the sterility assurance control strategy. Key position responsibility is to address technical challenges and provide guidance/coaching to a technical staff, assist in prioritization, address GMP compliance issues, and ensure implementation of SAT functional initiatives.  The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for sterility assurance.  Influence and implement the technical agenda within a multi-discipline technical environment.  Work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives.

Responsibilities:

Lead and develop a team of sterility assurance professionals, ensuring alignment with site and corporate goals.Oversee and support technical activities related to aseptic processing, including validation, deviation investigations, and process improvements.Ensure compliance with cGMP, global regulatory requirements, and internal standards.Represent sterility assurance in audits and inspections; coordinate internal audit activities.Review and approve technical documentation, including validation protocols, reports, and quality records.Drive continuous improvement and simplification initiatives to enhance sterility assurance processes and resource efficiency.Collaborate with cross-functional teams including QA, Engineering, Production, and Laboratories.Monitor and report on key performance indicators related to sterility assurance.Support strategic planning and execution of technical projects within the TS/MS function.

Basic Requirements:

Bachelors in scientific disciplines of Microbiology, Biology, or other related scienceMust have at least 5 years of experience. Experience in Manufacturing, Quality Control, Quality Assurance, Regulatory Sciences, or Engineering. Applied micro or parenteral experience strongly preferred.

Additional Skills/Preferences:

Strong knowledge of pharmaceutical quality systems and aseptic processing.Proven ability to lead technical teams and manage complex investigations.Strong interpersonal, organizational, and problem-solving skills.Six Sigma Green Belt or Black Belt certification.Experience working in a global or matrixed organization.

Additional Information:

8 hour days –Monday through FridayOvertime will be requiredRequired to respond off shift to operational issues, as needed.Minimal Travel requiredApplicant will work in various areas within the Parenteral Plant.  Some allergens are present in the parenteral plant.  Mobility requirements and exposure to allergens should be considered when applying for this position.

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.

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