Associate Director - TS/MS - Advanced Therapies Manufacturing
About the role
Lilly is seeking a TS/MS Associate Director to join the team responsible for building a state-of-the-art facility and technical system from the ground up. This role plays a key role in the design and startup of the site, supporting both clinical and commercial supply.
Responsibilities
- Lead technology transfer of new modalities to the site
- Develop and execute process and validation strategies
- Establish and maintain robust process control and capability
- Ensure GMP compliance across all associated documentation and activities
- Provide technical oversight, review, and approval of GMP documentation
- Partner cross-functionally to define and execute the site technical agenda
- 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
- Develop and implement site operating systems and processes
Requirements
- 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
Qualifications
- Deep knowledge of cGMPs, gene therapy platforms, global regulatory manufacturing expectations, and industry validation standards
- Demonstrated expertise and extensive experience in gene therapy processes, technologies, cGMP commercialization, and regulatory expectations
- 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
Skills
- Technical leadership
- Project management
- Problem-solving
- Communication and influencing
- Strategic thinking
Benefits
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).
Pay
The anticipated wage for this position is $123,000 - $180,400
Schedule
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).