Associate Director - TSMS Dry External Manufacturing
Eli Lilly and Company
19 days ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Manage TS/MS and ENG personnel supporting oversight of external manufacturing of dry products.
- Coach and develop technical/engineering staff; prioritize and staff routine production support.
- Lead/oversee technical projects, technical transfers, commercialization activities, process optimizations, and engineering activities.
- Ensure cGMP compliance and adherence to global regulatory guidance and validation/engineering standards.
- Provide technical document review/approval (investigations, change controls, regulatory submissions, validations, CAPA, procedures, strategies, studies, etc.).
- Oversee oral solid dose manufacturing/packaging stewardship (incl. dry intermediates such as spray dried/amorphous solid dispersions).
- Drive technical agenda to improve process control, yield, productivity, capacity, and quality across site portfolio; ensure governance engagement and global best-practice harmonization.
- Oversee investigations/complaints improvements and CAPA; escalate risks (supply, deviations, critical complaints, safety/cybersecurity) to senior leaders.
- Contribute to CM selection and business/strategic planning; serve on DryEM Lead Team; support financial planning/reporting.
Qualifications:
- Bachelor’s degree in Chemistry, Biology, Biotechnology, Pharmacy, Engineering, or related field.
- 8+ years in dry products/oral solid dose manufacturing (TS/MS, Production, Engineering).
- Prior leadership/people management experience.
Preferred Skills:
- Ability to influence via ethics and mission alignment; influence diverse teams.
- Experience with statistics; strong analytical/problem-solving, technical leadership, organization, and cross-functional communication.
- Ability to manage complex projects; strategic thinking; virtual/complex environment capability.
Additional Information:
- ~20–30% travel; some night/weekend/off-shift support for 24/7 operations.
Benefits (summary):
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (e.g., EAP, fitness benefits, clubs/activities).
- Manage TS/MS and ENG personnel supporting oversight of external manufacturing of dry products.
- Coach and develop technical/engineering staff; prioritize and staff routine production support.
- Lead/oversee technical projects, technical transfers, commercialization activities, process optimizations, and engineering activities.
- Ensure cGMP compliance and adherence to global regulatory guidance and validation/engineering standards.
- Provide technical document review/approval (investigations, change controls, regulatory submissions, validations, CAPA, procedures, strategies, studies, etc.).
- Oversee oral solid dose manufacturing/packaging stewardship (incl. dry intermediates such as spray dried/amorphous solid dispersions).
- Drive technical agenda to improve process control, yield, productivity, capacity, and quality across site portfolio; ensure governance engagement and global best-practice harmonization.
- Oversee investigations/complaints improvements and CAPA; escalate risks (supply, deviations, critical complaints, safety/cybersecurity) to senior leaders.
- Contribute to CM selection and business/strategic planning; serve on DryEM Lead Team; support financial planning/reporting.
Qualifications:
- Bachelor’s degree in Chemistry, Biology, Biotechnology, Pharmacy, Engineering, or related field.
- 8+ years in dry products/oral solid dose manufacturing (TS/MS, Production, Engineering).
- Prior leadership/people management experience.
Preferred Skills:
- Ability to influence via ethics and mission alignment; influence diverse teams.
- Experience with statistics; strong analytical/problem-solving, technical leadership, organization, and cross-functional communication.
- Ability to manage complex projects; strategic thinking; virtual/complex environment capability.
Additional Information:
- ~20–30% travel; some night/weekend/off-shift support for 24/7 operations.
Benefits (summary):
- Eligible for company bonus; 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits (e.g., EAP, fitness benefits, clubs/activities).