Associate Director - TS/MS - Advanced Therapies Manufacturing

Biopharma Careers; Lebanon (KY); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

ERGs

Well-being benefits

Job summary

Lilly is constructing a state-of-the-art manufacturing facility in Lebanon, Indiana, to support Advanced Therapies. The TS/MS Associate Director will provide technical and people leadership across Drug Substance and Drug Product processes, balancing day-to-day production support with strategic project delivery and process improvements.

Key responsibilities include leading technology transfer, developing validation strategies, ensuring GMP compliance, and partnering with Engineering, Operations,

Qualifications

• BS/MS in Biochemistry, Biotechnology, Biochemical engineering or related field.
• 5+ years of cGMP commercial manufacturing experience in TS/MS or related disciplines.
• 3+ years of experience leading teams.

Responsibilities

• Lead technology transfer of new modalities to the site with strong execution.
• Develop and execute process and validation strategies for cGMP manufacturing.
• Establish robust process control and capability with regulatory alignment.
• Oversee GMP documentation: investigations, deviations, and validations.
• Drive site technical agenda in cross-functional, multi-site collaborations.

Skills

cGMP experience

Team leadership

Cross-functional collaboration

Process improvement

Regulatory understanding

Education

BS/MS in Biochemistry/Biotechnology/Biochemical engineering

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.

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.

Lilly is currently constructing a cutting-edge manufacturing facility in Lebanon, Indiana, dedicated to the production of new modalities for Advanced Therapies. This site will be Lilly's most technically advanced manufacturing facility, purpose-built to deliver the next wave of innovative medicines. The facility will leverage next-generation manufacturing technologies and advanced data collection and analytics platforms to drive step-change improvements in safety, quality, and process performance. This is a unique opportunity to join the team responsible for building a state-of-the-art facility and technical system from the ground up. The successful candidate will play a key role in the design and startup of the site, supporting both clinical and commercial supply. The TS/MS organization will own end-to-end responsibility for technology transfer, process validation, and ongoing process stewardship.

Position Description:

The TS/MS Associate Director provides technical and people leadership across Drug Substance and Drug Product processes supporting cGMP late-phase and commercial manufacturing for advanced therapies. This role balances day‑to‑day production support with delivery of technical projects and process improvements, ensuring strong prioritization, execution, and team performance. Key responsibilities include leading technology transfer of new modalities to the site; developing and executing process and validation strategies; establishing and maintaining robust process control and capability; and ensuring GMP compliance across all associated documentation and activities. The role requires deep knowledge of cGMPs, gene therapy platforms, global regulatory manufacturing expectations, and industry validation standards. The Associate Director partners closely with Engineering, Operations, Quality Assurance, Quality Control, Development, Central TS/MS, and Regulatory functions to drive the site’s technical agenda in a highly cross‑functional environment. The position also interfaces with other Lilly manufacturing sites and external contract manufacturers.

Key Objectives/Deliverables:

• Lead and promote a strong safety culture; ensure compliance with all corporate and site Health, Safety, and Environmental (HSE) requirements.
• Drive performance management, coaching, and development of TSMS staff to build a high-performing technical organization.
• Demonstrated expertise and extensive experience in gene therapy processes, technologies, cGMP commercialization, and regulatory expectations.
• Provide technical oversight, review, and approval of GMP documentation, including investigations, deviations, change controls, validations, regulatory submissions, annual product reviews, batch records, procedures, control strategies, and technical studies.
• Partner cross‑functionally to define and execute the site technical agenda in alignment with business objectives and the GMP Quality Plan.
• Serve as a technical representative in regulatory interactions, audits, and engagements with external stakeholders.
• Set strategic technical direction to improve process control, robustness, yield, productivity, and overall manufacturing performance.
• Ensure strong technical governance and timely closure of investigations and product complaints.
• Oversee technical projects focused on improving process capability, capacity, quality, and team effectiveness.
• Represent the site within the manufacturing network to influence and align technical priorities.
• Drive global knowledge sharing and harmonization of best practices, scientific rationale, and control strategies.
• Support and lead technology transfer and commercialization of new molecule entities through close collaboration with Development and Central teams, and provide technical oversight of manufacturing activities at external manufacturing sites.
• Develop and implement site operating systems and processes, leveraging established Lilly practices while incorporating external best practices where appropriate.

Basic Requirements:

• BS/MS in Biochemistry, Biotechnology, Biochemical engineering or related field.
• 5+ years of cGMP commercial manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
• 3+ years of experience leading teams

Additional Preferences:

• Experience supporting AAV and/or mRNA/LNP manufacturing in a GMP environment.
• Demonstrated technical leadership with strong administrative, organizational, and people-management skills.
• Proven ability to deliver highly complex, cross‑functional work in fast-paced or evolving manufacturing environments.
• Strong project management capability, including coordination of multi‑disciplinary technical projects.
• Excellent analytical, quantitative, and root‑cause problem‑solving skills.
• Effective communication and influencing skills, with the ability to engage stakeholders across functions and organizational levels.
• Strategic mindset with the ability to balance short‑term execution needs and long‑term business and technology evolution.
• Demonstrated ability to rapidly learn, apply, and translate technical and scientific knowledge into practical manufacturing solutions.

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 $123,000 - $180,400 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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