Associate Director - TS/MS - Advanced Therapies Manufacturing
BioSpace, Lebanon, IN, United States
We are a global healthcare leader headquartered in Indianapolis, Indiana, committed to discovering and delivering life‑changing medicines.
Position Description The TS/MS Associate Director will provide technical and people leadership across Drug Substance and Drug Product processes, supporting cGMP late‑phase and commercial manufacturing for advanced therapies at Lilly’s new cutting‑edge facility in Lebanon, Indiana.
Key Objectives / Deliverables
Lead and promote a strong safety culture and ensure compliance with all corporate and site HSE requirements.
Drive performance management, coaching, and development of TS/MS 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.
Compensation Salary range: $123,000 – $180,400.
Benefits Lilly offers a comprehensive benefit program, including eligibility for a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug coverage, flexible benefits such as healthcare and dependent day‑care flexible spending accounts, life and death insurance, leave of absence, employee assistance program, fitness benefits, and employee clubs and activities.
Equal Opportunity Employer 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.
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Position Description The TS/MS Associate Director will provide technical and people leadership across Drug Substance and Drug Product processes, supporting cGMP late‑phase and commercial manufacturing for advanced therapies at Lilly’s new cutting‑edge facility in Lebanon, Indiana.
Key Objectives / Deliverables
Lead and promote a strong safety culture and ensure compliance with all corporate and site HSE requirements.
Drive performance management, coaching, and development of TS/MS 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.
Compensation Salary range: $123,000 – $180,400.
Benefits Lilly offers a comprehensive benefit program, including eligibility for a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug coverage, flexible benefits such as healthcare and dependent day‑care flexible spending accounts, life and death insurance, leave of absence, employee assistance program, fitness benefits, and employee clubs and activities.
Equal Opportunity Employer 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.
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