Sr. Principal Scientist - Molecule Steward
Eli Lilly and Company
Full-time
Remote friendly (Concord, NC)
United States
Operations
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Role Summary
Sr. Principal Scientist - Molecule Steward at Lilly. The Molecule Steward is the subject matter expert for Concord Site Drug Product manufacturing, providing local technical leadership and expertise for projects involving Technical Services/Manufacturing Sciences (TS/MS).
Responsibilities
- Assume ownership of control strategy implementation and execution at the manufacturing site.
- Lead the technical transfer for applicable products to the site.
- Interact with peers across the parenteral network, including TS/MS, QA, QC, Regulatory and Engineering, both site and central.
- Share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.
- Play a critical role in technical capability building and coaching at the site to ensure capabilities are in place to meet business objectives.
- Serve as technical subject matter expert for all topics related to drug product manufacturing.
- Provide technical direction on deviations, production challenges, and impact assessment of change controls.
- Generate documentation to support the product/program, as needed.
- Represent the TS/MS function in regulatory interactions, as needed.
- Be responsible and influential with respect to implementation of external/corporate trends and understanding of how these changes could impact the Concord site.
- Exhibit excellent technical writing and oral communication skills and effectively transfer knowledge to all levels of the organization.
- Demonstrate technical leadership and the ability to cross-functionally influence, even though the role is not supervisory.
Qualifications
- Minimum of bachelor's degree in science or engineering field.
- Minimum of 5 years directly supporting parenteral product manufacturing.
Skills
- Strong communication skills.
- Ability to prioritize and multi-task effectively.
- Ability to collaborate with other functions as teams as appropriate.
Education
- Bachelor's degree in science or engineering field.
Additional Requirements
- This position is tech ladder approved (R4+). Final level based on candidate.
- Requires collaboration with peers across the network.
- Day shift, Monday-Friday, with off hours support as needed.