IDAP TS/MS Steward

Position: Technical Services Manufacturing Scientist (TS/MS) Product Steward

Responsibilities / Key Objectives:
- Own Tech Transfer and Validation strategy for the manufacturing site
- Participate in equipment/product/format commissioning, qualification, and validation activities
- Represent TS/MS team to the IDAP Site Lead team
- Provide technical support to 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 projects to improve process control and/or productivity
- Drive technical consistency across process teams
- Serve as interface with upstream suppliers and global device/drug product networks
- Serve as a technical mentor to TS/MS staff and other disciplines
- Collaborate with the Commercialization Project Manager and cross-functional teams to commercialize new products in IDAP

Minimum 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
- Ability to maintain a safe work environment and support HSE Corporate and Site Goals
- Authorized to work in the United States full-time; no visa/work authorization sponsorship

Additional Preferences:
- 5+ years in a manufacturing organization
- Experience across multiple manufacturing functions (operations, engineering, quality, etc.)
- TS/MS or technical function experience in manufacturing
- Pharmaceutical manufacturing; Root Cause Investigation experience
- Leadership/mentorship of cross-functional teams; technical writing skills

Other:
- Some travel (~10%) may be required
- Location: Lilly Technology Center – South campus