Associate Director - TS/MS - Lebanon API
Eli Lilly and Company
3 months ago
On-site
Lebanon, IN
$123,000 - $180,400 USD yearly
Operations
Position Description
Associate Director – Technical Services/Manufacturing Science (TSMS) responsible for managing TSMS personnel and balancing coaching, prioritization/staffing, technical project implementation, and process optimizations. Requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and validation standards; works cross-functionally to deliver technical, product business plan, and quality objectives.
Responsibilities
- Ensure technical review/approval of documents (e.g., investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flows, personnel qualification strategies, control strategies, technical studies).
- Perform formal performance management and staff development; coach and direct team members.
- Partner within TSMS and across functions to implement the technical agenda, site business plan, and GMP Quality Plan objectives.
- Liaise with regulators/customers/external stakeholders and support internal/external audits.
- Set strategic direction and provide oversight for the technical agenda to improve process control, yield, and productivity.
- Provide oversight for investigations and complaints; ensure technical excellence.
- Provide oversight for technical projects to improve process control, capacity, yield, and quality.
- Represent TSMS in site/network governance meetings to influence technical agendas.
- Network globally to share best practices, rationale, and control strategies for harmonization.
- Potentially engage Pharmaceutical Product Development groups for technical transfer deliverables for new molecule entities during commercialization.
Startup phase (2025–2027): Lebanon API site
- Build organization capability/capacity/culture for operational excellence.
- Develop and implement site systems and processes (leveraging existing practices and external learning).
- Ensure regulatory compliance and operational excellence by supporting lean principles.
- Support project team delivery to the site team (feedback and support).
Basic Qualifications
- Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related field.
- 5+ years TSMS experience in pharmaceutical manufacturing.
- 2+ years leading teams.
Additional Preferences / Skills
- Work with teams; make independent decisions; influence diverse groups.
- Instill teamwork and demonstrate strong interpersonal skills.
- Provide innovative solutions and leverage ideas across functions.
- Demonstrated project management skills coordinating complex projects.
Compensation & Benefits (as stated)
- Anticipated base pay: $123,000–$180,400.
- Company bonus eligibility (depending on company/individual performance).
- Benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
Associate Director – Technical Services/Manufacturing Science (TSMS) responsible for managing TSMS personnel and balancing coaching, prioritization/staffing, technical project implementation, and process optimizations. Requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and validation standards; works cross-functionally to deliver technical, product business plan, and quality objectives.
Responsibilities
- Ensure technical review/approval of documents (e.g., investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flows, personnel qualification strategies, control strategies, technical studies).
- Perform formal performance management and staff development; coach and direct team members.
- Partner within TSMS and across functions to implement the technical agenda, site business plan, and GMP Quality Plan objectives.
- Liaise with regulators/customers/external stakeholders and support internal/external audits.
- Set strategic direction and provide oversight for the technical agenda to improve process control, yield, and productivity.
- Provide oversight for investigations and complaints; ensure technical excellence.
- Provide oversight for technical projects to improve process control, capacity, yield, and quality.
- Represent TSMS in site/network governance meetings to influence technical agendas.
- Network globally to share best practices, rationale, and control strategies for harmonization.
- Potentially engage Pharmaceutical Product Development groups for technical transfer deliverables for new molecule entities during commercialization.
Startup phase (2025–2027): Lebanon API site
- Build organization capability/capacity/culture for operational excellence.
- Develop and implement site systems and processes (leveraging existing practices and external learning).
- Ensure regulatory compliance and operational excellence by supporting lean principles.
- Support project team delivery to the site team (feedback and support).
Basic Qualifications
- Bachelor’s degree in chemistry, biology, pharmacy, engineering, or related field.
- 5+ years TSMS experience in pharmaceutical manufacturing.
- 2+ years leading teams.
Additional Preferences / Skills
- Work with teams; make independent decisions; influence diverse groups.
- Instill teamwork and demonstrate strong interpersonal skills.
- Provide innovative solutions and leverage ideas across functions.
- Demonstrated project management skills coordinating complex projects.
Compensation & Benefits (as stated)
- Anticipated base pay: $123,000–$180,400.
- Company bonus eligibility (depending on company/individual performance).
- Benefits: 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.