IDAP TS/MS Steward
Eli Lilly and Company
4 hours ago
On-site
Indianapolis, IN
IT
Technical Services Manufacturing Scientist (TS/MS) Product Steward
Responsibilities
- Provide technical leadership across all processes and products within the Indianapolis Device Assembly and Packaging (IDAP) site.
- Maintain the validated state of all IDAP processes.
- Establish metrics to ensure process capability and control; harmonize control strategies across process teams.
- Improve processes and serve as an escalation point for day-to-day operations.
- Provide technical leadership for commercialization activities at the site.
- Own tech transfer and validation strategy for the manufacturing site.
- Participate in equipment/product/format commissioning, qualification, and validation.
- Represent TS/MS team to the IDAP Site Lead team.
- Support non-routine investigations (e.g., deviations, complaints).
- Prepare, review, and approve technical documents (annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.).
- Monitor process control and capabilities; lead technical improvement projects.
- Drive technical consistency across process teams.
- Interface with upstream suppliers and global device/drug product networks.
- Mentor TS/MS employees and other disciplines within IDAP.
- Collaborate with Commercialization Project Manager and cross-functional tech transfer teams to commercialize new products in IDAP.
Qualifications/Requirements
- Bachelor’s degree or higher in engineering, science, or related field.
- Good written and oral communications.
- Clear understanding of cGMPs.
- Good teamwork and interpersonal skills.
- Maintain a safe work environment and support HSE Corporate and Site Goals.
- Authorization to work in the United States full-time (Lilly does not sponsor work authorization/visas).
Additional Preferences
- 5+ years of manufacturing experience.
- Experience across multiple functions within a manufacturing site.
- TS/MS or technical function experience in manufacturing.
- Pharmaceutical manufacturing experience.
- Root cause investigation experience.
- Demonstrated leadership/mentorship of cross-functional teams.
- Demonstrated technical writing skills.
Other Information
- Some travel (~10%) may be required.
- Location: Lilly Technology Center – South campus.
Benefits (as stated)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave of absence, and well-being benefits (e.g., employee assistance, fitness, clubs).
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities
- Provide technical leadership across all processes and products within the Indianapolis Device Assembly and Packaging (IDAP) site.
- Maintain the validated state of all IDAP processes.
- Establish metrics to ensure process capability and control; harmonize control strategies across process teams.
- Improve processes and serve as an escalation point for day-to-day operations.
- Provide technical leadership for commercialization activities at the site.
- Own tech transfer and validation strategy for the manufacturing site.
- Participate in equipment/product/format commissioning, qualification, and validation.
- Represent TS/MS team to the IDAP Site Lead team.
- Support non-routine investigations (e.g., deviations, complaints).
- Prepare, review, and approve technical documents (annual product reviews, change controls, regulatory submissions, deviations, validations, procedures, PFDs, PFMEAs, etc.).
- Monitor process control and capabilities; lead technical improvement projects.
- Drive technical consistency across process teams.
- Interface with upstream suppliers and global device/drug product networks.
- Mentor TS/MS employees and other disciplines within IDAP.
- Collaborate with Commercialization Project Manager and cross-functional tech transfer teams to commercialize new products in IDAP.
Qualifications/Requirements
- Bachelor’s degree or higher in engineering, science, or related field.
- Good written and oral communications.
- Clear understanding of cGMPs.
- Good teamwork and interpersonal skills.
- Maintain a safe work environment and support HSE Corporate and Site Goals.
- Authorization to work in the United States full-time (Lilly does not sponsor work authorization/visas).
Additional Preferences
- 5+ years of manufacturing experience.
- Experience across multiple functions within a manufacturing site.
- TS/MS or technical function experience in manufacturing.
- Pharmaceutical manufacturing experience.
- Root cause investigation experience.
- Demonstrated leadership/mentorship of cross-functional teams.
- Demonstrated technical writing skills.
Other Information
- Some travel (~10%) may be required.
- Location: Lilly Technology Center – South campus.
Benefits (as stated)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance/death benefits, time off/leave of absence, and well-being benefits (e.g., employee assistance, fitness, clubs).
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation