Associate Director TSMS
Eli Lilly and Company
August 21, 2026
Remote friendly (Indianapolis, IN)
United States
Other
Responsibilities:
- Provide technical review/approval for documents (investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow docs, personnel qualification strategies, control strategies, technical studies, etc.).
- Hire, manage, mentor, and develop a team of scientists/technical staff; foster excellence, accountability, and continuous learning.
- Partner within TSMS and cross-functionally to influence/implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Support regulators/customers/stakeholders and internal/external agency audits.
- Ensure oversight and technical excellence for investigations/complaints; improve process control, capacity, yield, and quality.
- Represent/engage in site and network governance meetings to influence technical agendas.
- Network globally to share best practices and harmonize control strategies.
- Engage Pharmaceutical Product Development for technical transfer deliverables for new molecule entities.
- Champion data analytics, SPC, and real-time monitoring to improve performance and reduce variability.
- Partner with Digital/IT and Engineering to implement a site digitalization roadmap; drive MES, digital execution, data historians, and analytics dashboards.
Basic Qualifications:
- B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, or Pharmaceutical Sciences.
- 6+ years (B.S./M.S.) or 5+ years (Ph.D.) relevant cGMP commercial API manufacturing experience in TSMS or related disciplines.
Preferred Skills/Experience:
- Hands-on digitalization experience (MES, data historians such as OSIsoft PI, digital execution, LIMS).
- Track record with continuous improvement using digital tools/analytics; technical leadership and project management; strong analytical/quantitative problem-solving.
- Ability to influence across cross-functional stakeholders; strategic thinking and balance short/long-term needs.
Additional Information:
- Minimal travel (<10%); some night/weekend/off-shift support may be required for 24/7 operations.
- Provide technical review/approval for documents (investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow docs, personnel qualification strategies, control strategies, technical studies, etc.).
- Hire, manage, mentor, and develop a team of scientists/technical staff; foster excellence, accountability, and continuous learning.
- Partner within TSMS and cross-functionally to influence/implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Support regulators/customers/stakeholders and internal/external agency audits.
- Ensure oversight and technical excellence for investigations/complaints; improve process control, capacity, yield, and quality.
- Represent/engage in site and network governance meetings to influence technical agendas.
- Network globally to share best practices and harmonize control strategies.
- Engage Pharmaceutical Product Development for technical transfer deliverables for new molecule entities.
- Champion data analytics, SPC, and real-time monitoring to improve performance and reduce variability.
- Partner with Digital/IT and Engineering to implement a site digitalization roadmap; drive MES, digital execution, data historians, and analytics dashboards.
Basic Qualifications:
- B.S./M.S./Ph.D. in Chemistry, Chemical Engineering, or Pharmaceutical Sciences.
- 6+ years (B.S./M.S.) or 5+ years (Ph.D.) relevant cGMP commercial API manufacturing experience in TSMS or related disciplines.
Preferred Skills/Experience:
- Hands-on digitalization experience (MES, data historians such as OSIsoft PI, digital execution, LIMS).
- Track record with continuous improvement using digital tools/analytics; technical leadership and project management; strong analytical/quantitative problem-solving.
- Ability to influence across cross-functional stakeholders; strategic thinking and balance short/long-term needs.
Additional Information:
- Minimal travel (<10%); some night/weekend/off-shift support may be required for 24/7 operations.