Advisor - Local Site Technical Services Molecule Steward - Molecule

Advisor - Local Site Technical Services Molecule Steward - Small Molecule

At Lilly, we unite caring with discovery to make life better for people around the world. This role serves as the technical representative for the Lebanon facility. The position collaborates with central TSMS teams and other manufacturing sites to ensure robust molecule stewardship, seamless transfer of API from pre‑commercial to commercial stages, and commercialization support for new molecules.

• Provide technical oversight and stewardship for one or more molecules manufactured at the Lebanon facility. Lead technical transfer of processes between production facilities. Anticipate and address complex scale‑up issues.
• Facilitate process knowledge transfer to Process Team members and assist in process‑related training for Manufacturing Process Team members.
• Collaborate with Manufacturing to support the start‑up and qualification of new facilities and associated process equipment.
• Author, review, or approve standard operating procedures related to TS/MS activities. Review and approve manufacturing batch records and other documentation.
• Authorize technical documents supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, and technical studies.
• Lead resolution of technical issues related to control strategy and manufacturing.
• Anticipate and resolve key technical or operational problems, communicating issues promptly and leading process‑related investigations.
• Mentor and provide scientific expertise to Process Team members; apply process knowledge and data analysis skills to support API manufacturing operations.
• Design laboratory experiments to guide process troubleshooting and continuous process improvement. Implement medium to large continuous improvements to manufacturing processes.
• Lead post‑launch technical agendas and deliver projects that drive substantial step changes in manufacturing.
• Interact with regulators or stakeholders on technical issues or in support of internal and external agency audits.
• Lead or assist in planning and execution of process validation activities and large process‑related change controls.
• Make decisions that impact a function or geography, building relationships with internal and external partners.
• Perform all job responsibilities in compliance with quality, safety and regulatory expectations as well as cGMP.

• Education Level: Bachelor’s degree in Chemistry, Engineering, Pharmaceutical Sciences, or a related field (Chemistry focus preferred).
• Experience:
  
  Minimum of 10 years of direct experience in cGMP API manufacturing, covering multiple unit operations and platforms related to API development, commercialization, and commercial production.

• Strong technical leadership and communication skills.
• Advanced analytical and problem‑solving skills.
• Deep understanding of process and cleaning validations, commercialization strategies, and execution.
• Ability to integrate multiple technology disciplines to advance programs.
• Effective prioritization and multitasking capabilities.
• Collaborative mindset with cross‑functional teams.

• Position Location:
  
  US:
  Lebanon IN (LP1 site)
• Travel Percentage: 5‑30%
• Shift Information: 8‑hour shift, 5 days a week. Occasional night and weekend work may be required.

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Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.