Sr. Scientist - TS/MS Materials Management - Advanced Therapies Manufacturing
Eli Lilly and Company
9 hours ago
On-site
Lebanon, IN
Operations
Sr. Scientist – Materials Management – Technical Services/Manufacturing (TS/MS)
Responsibilities
- Provide technical oversight of raw materials and consumables used in manufacturing gene therapy products to ensure reliable supply, safety, and quality.
- Support qualification, implementation, continuous improvement, investigation support, and technology transfer.
- Serve as scientific liaison between Materials Management and Process Scientists.
- Establish and own the site Extractables and Leachables (E&L) program, including documented risk assessments to enable manufacturing start.
- Work with Materials Management to:
- Assess materials and supplier risk
- Audit suppliers
- Assess and address impacts of supplier changes
- Develop robust control strategies to manage supplier/material risk
- Prepare, review, approve, and provide technical support for documents including change controls, deviation investigations, plant trial protocols and summary reports, procedures, and technical reports.
- Lead and/or coordinate materials investigations and changes.
- Collaborate with site/global resources on materials-related laboratory studies.
- Own or provide input to materials components of Annual Product Reviews and Management System Reviews.
- Partner with manufacturing Process Teams to assess/investigate materials issues and implement materials changes.
Basic Requirements
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or related quantitative field.
- 3+ years of experience in cGMP manufacturing (TS/MS, Validation, Operations, or Engineering).
- Experience liaising with material and consumable suppliers.
Additional Preferences
- M.S. in related field.
- Knowledge of cell culture, purification, and biotech manufacturing support systems.
- High productivity technical capability; learning agility.
- Self-starter with initiative and data-driven problem-solving.
- Strong interpersonal and verbal/written communication skills.
- Ability to adapt across environments/teams; participate in and facilitate decision-making.
- Experience in external manufacturing.
Benefits
- Eligible for company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits (e.g., healthcare/dependent day care FSAs), life insurance/death benefits, certain time off/leave benefits, and well-being benefits.
- Full-time employees may be eligible for a company bonus (depending on company/individual performance).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
Responsibilities
- Provide technical oversight of raw materials and consumables used in manufacturing gene therapy products to ensure reliable supply, safety, and quality.
- Support qualification, implementation, continuous improvement, investigation support, and technology transfer.
- Serve as scientific liaison between Materials Management and Process Scientists.
- Establish and own the site Extractables and Leachables (E&L) program, including documented risk assessments to enable manufacturing start.
- Work with Materials Management to:
- Assess materials and supplier risk
- Audit suppliers
- Assess and address impacts of supplier changes
- Develop robust control strategies to manage supplier/material risk
- Prepare, review, approve, and provide technical support for documents including change controls, deviation investigations, plant trial protocols and summary reports, procedures, and technical reports.
- Lead and/or coordinate materials investigations and changes.
- Collaborate with site/global resources on materials-related laboratory studies.
- Own or provide input to materials components of Annual Product Reviews and Management System Reviews.
- Partner with manufacturing Process Teams to assess/investigate materials issues and implement materials changes.
Basic Requirements
- B.S. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or related quantitative field.
- 3+ years of experience in cGMP manufacturing (TS/MS, Validation, Operations, or Engineering).
- Experience liaising with material and consumable suppliers.
Additional Preferences
- M.S. in related field.
- Knowledge of cell culture, purification, and biotech manufacturing support systems.
- High productivity technical capability; learning agility.
- Self-starter with initiative and data-driven problem-solving.
- Strong interpersonal and verbal/written communication skills.
- Ability to adapt across environments/teams; participate in and facilitate decision-making.
- Experience in external manufacturing.
Benefits
- Eligible for company-sponsored 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits (e.g., healthcare/dependent day care FSAs), life insurance/death benefits, certain time off/leave benefits, and well-being benefits.
- Full-time employees may be eligible for a company bonus (depending on company/individual performance).
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation