Overview
Join the External Manufacturing Organization (API-EM) within the Technical Services/Manufacturing Sciences (TS/MS) team to provide technical support and scientific expertise across Peptides and Oligonucleotides (TIDES). The Senior/Principal Scientist acts as a subject matter expert responsible for supporting the manufacture of API drug substance at external contract manufacturers to predefined global quality standards. The role requires interaction with external partners, process team members, and site management, with a focus on technical transfer, process stewardship, and continuous improvement.
The position requires knowledge of cGMPs, regulatory manufacturing guidance, and corporate/industry standards. The incumbent should possess an investigative mindset, strong critical thinking, and a collaborative working style. The role involves cross-functional work within the site and with other functions to deliver technical objectives.
Key Objectives/Deliverables
* Provide technical oversight and stewardship for peptide and/or oligonucleotide manufacturing processes.
* Lead resolution of technical issues including control strategy and manufacturing challenges.
* Use effective communication to manage internal and external relationships, conduct investigations, and disseminate actionable outputs.
* Build and maintain relationships with development partners and central technical organizations.
* Characterize processes and justify process descriptions, measures, ranges, and specifications. Apply advanced data analytics to align PROVABLE Acceptable Ranges (PAR) and NOR with process capability.
* Ensure processes are compliant, capable, in control, and maintained in a validated/qualified state through monitoring; identify signals of process weakness and proactively resolve or escalate.
* Justify and document process validation data to evaluate manufacturing capability.
* Initiate deviation records and ensure timely closure with appropriate CAPAs and effectiveness checks; demonstrate structured problem solving.
* Support regulatory submissions with technical input; author/review annual reports and stay aware of regulatory best practices.
* Influence and implement the network technical agenda and drive continuous improvement with change controls.
* Maintain peptide/oligonucleotide processes in a state of compliance with US and global regulations.
* Understand scientific principles for manufacturing intermediates and drug substances and the interaction of chemistry and equipment.
* Operate with a “Team Lilly” mindset, including coaching and mentoring peers and other scientists.
Basic Requirements
* Bachelors in Chemistry, Biochemistry, Biology, Pharmacy, or Engineering (Chemistry or Biochemistry strongly preferred)
* 3+ years of demonstrated experience with pharmaceutical manufacturing and working knowledge of regulatory expectations
Additional Preferences
* Knowledge and experience with regulatory requirements
* Flexibility, team spirit, and enthusiasm for change
* Ability to influence and communicate with diverse groups on business or technical issues
* Project management skills and ability to coordinate complex, cross-functional tasks
Additional Information
* Some travel may be required; some off-shift work (night/weekend) may be needed to support 24/7 operations
* Lilly is committed to providing accommodations for applicants with disabilities. If accommodation is required, submit the accommodation request form for assistance. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, or other protected status.
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