Associate Director - TSMS PAR
Eli Lilly and Company
June 29, 2026
On-site
Concord, NC
Market Access
Responsibilities:
- Lead the staffing, training, and leadership of the TS/MS group providing technical leadership for PAR (formulation, filling, visual inspection) or DAP (device assembly, packaging) operations for products transferred to the Concord site.
- Support day-to-day TS/MS activities and plan for a 3–6 month horizon; coach others in safety, quality, technical capability, and continuous improvement.
- Deliver equipment/lines via technology transfer, process validation, and control strategy development.
- Lead business plan goal execution for safety, quality, and process effectiveness/efficiency; define objectives.
- Determine staffing/resources; maintain performance metrics and make improvements.
- Provide technical guidance; support Continuous Improvement, RCA, and FMEA strategies.
- Support regulatory inspection readiness; direct interaction with Regulatory Agencies.
- Influence manufacturing control strategy; manage external contracts/resources and project management resources.
- Review/approve GMP documentation (procedures, deviations, technical reports, change controls, regulatory submissions, validation protocols/summary reports, PFDs, APRs, etc.) and manage issue/deviation workflows cross-functionally.
- Drive control, capability, productivity, and continuous improvement; support/lead TS/MS technical projects for start-up and improved control, yield, quality, and/or productivity.
- Serve as external technical interface to Concord; collaborate cross-functionally and with global/parenteral sites.
- Ensure safe working environment and improve safety culture.
Basic Qualifications:
- BS/MS/Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related discipline.
- 1+ year management/leadership experience with cross-functional teams.
- 5+ years regulated industry experience.
- Authorized to work in the United States full-time; no visa sponsorship.
Additional Skills/Preferences:
- Technical aptitude; ability to train/mentor.
- Strong interpersonal and communication skills.
- Knowledge of regulatory requirements (e.g., FDA, DEKRA, OSHA).
- cGMP manufacturing experience (operations/TS/MSAT/QA).
- Experience with combination products, device assembly, pharmaceutical packaging; facility/area start-up.
- Equipment qualification and process validation; highly automated equipment.
- Deviation/change management systems (e.g., Trackwise).
Additional Information:
- Monday–Friday; flexible; occasional extended/off-hour support.
Compensation/Benefits:
- Anticipated base pay: $123,000–$180,400; company bonus eligibility and comprehensive benefits (medical/dental/vision, 401(k), etc.).
- Lead the staffing, training, and leadership of the TS/MS group providing technical leadership for PAR (formulation, filling, visual inspection) or DAP (device assembly, packaging) operations for products transferred to the Concord site.
- Support day-to-day TS/MS activities and plan for a 3–6 month horizon; coach others in safety, quality, technical capability, and continuous improvement.
- Deliver equipment/lines via technology transfer, process validation, and control strategy development.
- Lead business plan goal execution for safety, quality, and process effectiveness/efficiency; define objectives.
- Determine staffing/resources; maintain performance metrics and make improvements.
- Provide technical guidance; support Continuous Improvement, RCA, and FMEA strategies.
- Support regulatory inspection readiness; direct interaction with Regulatory Agencies.
- Influence manufacturing control strategy; manage external contracts/resources and project management resources.
- Review/approve GMP documentation (procedures, deviations, technical reports, change controls, regulatory submissions, validation protocols/summary reports, PFDs, APRs, etc.) and manage issue/deviation workflows cross-functionally.
- Drive control, capability, productivity, and continuous improvement; support/lead TS/MS technical projects for start-up and improved control, yield, quality, and/or productivity.
- Serve as external technical interface to Concord; collaborate cross-functionally and with global/parenteral sites.
- Ensure safe working environment and improve safety culture.
Basic Qualifications:
- BS/MS/Doctorate in Packaging Science, Mechanical Engineering, Pharmaceutical Sciences, Biochemical Engineering, Chemical Engineering, or related discipline.
- 1+ year management/leadership experience with cross-functional teams.
- 5+ years regulated industry experience.
- Authorized to work in the United States full-time; no visa sponsorship.
Additional Skills/Preferences:
- Technical aptitude; ability to train/mentor.
- Strong interpersonal and communication skills.
- Knowledge of regulatory requirements (e.g., FDA, DEKRA, OSHA).
- cGMP manufacturing experience (operations/TS/MSAT/QA).
- Experience with combination products, device assembly, pharmaceutical packaging; facility/area start-up.
- Equipment qualification and process validation; highly automated equipment.
- Deviation/change management systems (e.g., Trackwise).
Additional Information:
- Monday–Friday; flexible; occasional extended/off-hour support.
Compensation/Benefits:
- Anticipated base pay: $123,000–$180,400; company bonus eligibility and comprehensive benefits (medical/dental/vision, 401(k), etc.).