Associate Director - TS/MS - Advanced Therapies Manufacturing

Eli Lilly and Company; Lebanon (IN); On-site; USD 123,000 - 180,400; Full time

Benefits offered by this job

Company bonus

401(k)

Pension plan

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly’s TS/MS organization seeks a senior leader to drive end-to-end technology transfer and process improvements for drug substance and drug product in advanced therapies. The role requires deep cGMP knowledge, regulatory alignment, and cross‑functional collaboration to deliver robust manufacturing performance.

The Associate Director balances day-to-day production support with strategic projects, ensuring quality, safety, and compliance across facilities and external partners.

Qualifications

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

Responsibilities

• Lead technology transfer of new modalities to the site.
• Develop and execute process and validation strategies.
• Establish and maintain robust process control and GMP compliance.
• Provide technical oversight of GMP documentation, investigations, deviations, change controls, validations, regulatory submissions, and batch records.
• Partner cross-functionally to define and execute the site technical agenda.
• Serve as a technical representative in regulatory interactions, audits, and engagements with external stakeholders.
• Set strategic technical direction to improve process control, yield, and manufacturing performance.
• Oversee technical projects to improve process capability, capacity, quality, and team effectiveness.

Skills

Gene therapy

cGMP

Process validation

Leadership

Project management

Regulatory experience

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, dedicated to discovering and bringing life‑changing medicines, improving disease understanding and management, and giving back to communities through philanthropy and volunteerism. We give our best effort to our work and put people first, and we’re looking for people who are determined to make a difference for people worldwide.

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 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 Responsibilities

• 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 TS/MS staff to build a high‑performing technical organization.
• Demonstrate 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.

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.