Advisor - Local Site Technical Services Molecule Steward - Molecule

Advisor - Local Site Technical Services Molecule Steward - Small Molecule

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The TSMS Local Site Molecular Steward serves as the technical representative for the Lebanon facility. This role 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. This position requires comprehensive knowledge of the pharmaceutical industry, current Good Manufacturing Practices (cGMP), regulatory requirements, and advanced process chemistry.

The successful candidate should have a proven track record of driving technical and manufacturing agendas. The role involves cross‑functional collaboration within the site, across the network, and with commercialization teams and other functions.

• 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. 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. Help define and implement control strategies for Lilly Lebanon processes.
• Author, review, or approve standard operating procedures related to TS/MS activities. Review and approve manufacturing batch records and other documentation.
• Author, review, or approve technical documents supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Review and approve Annual Product Review and present annual Global Product Assessment for stewarded molecule(s).
• Serve as a technical leader supporting API manufacturing. Lead the resolution of technical issues, including those related to control strategy and manufacturing.
• Anticipate and resolve key technical or operational problems, communicate issues promptly, and lead process‑related investigations. Assess technical impact and influence complex regulatory or technical issues within the TS/MS. Encourage adoption of new perspectives on challenging concepts.
• Mentor and provide scientific expertise to Process Team members. Apply process knowledge and data analysis skills to support the API manufacturing operations. Drive solutions that impact results across sites or functions.
• As required, design laboratory experiments to guide process troubleshooting and continuous process improvement. Help define and 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 other stakeholders on technical issues or in support of internal and external agency audits.
• As required, may lead or assist in the planning and execution of process validation activities.
• As required, may own or assist in the implementation of medium to large process‑related change controls with greater risk, resource/financial requirements, or complexity.
• Make decisions that impact a function or geography. Build relationships with internal and external partners.
• Understand and 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…