Advisor - Technical Steward - TSMS

Main Purpose and Objectives

This position is part of the Technical Services & Manufacturing Sciences (TSMS) function and is responsible for stewardship and site transfer of commercial molecules, as well as commercialization support for new molecules. It will interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments, and may require interaction with other Lilly site/contract producers of Lilly products.

• Provides technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility.
• Leads the technical transfer of processes from one production facility to another, addressing complex scale‑up issues.
• Presents process data and analyses with Process Team members at Manufacturing Process Team meetings.
• Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.
• Reviews and approves Annual Product Review and presents annual Global Product Assessment for stewarded molecule(s).
• Leads resolution of technical issues including those related to control strategy and manufacturing; troubleshoots issues with Process Teams and/or manufacturing staff on the manufacturing floor.
• Anticipates and resolves key technical or operational problems that impact function or geography and communicates issues in a timely manner.
• May lead process‑related investigations and assess technical impact; influences complex regulatory or technical issues within the TSMS area/function.
• Writes standard operating procedures related to the activities of the TSMS group and reviews and approves manufacturing batch records and other manufacturing documentation.
• Works with Process Team members to ensure successful process knowledge transfer to Manufacturing staff and assists in process‑related training.
• Designs laboratory experiments in support of process troubleshooting and/or continuous improvement, and executes or coordinates execution in outside laboratories.
• Defines and implements medium to large continuous improvement projects and control strategies for Lilly Houston processes.
• Leads post‑launch technical agendas and delivers projects that drive substantial step changes in Manufacturing.
• May lead, or assist in, the planning and execution of process validation activities and medium to large process‑related change controls with greater risk, resource, or financial requirements.
• Builds relationships with internal and external partners and ensures all job responsibilities are performed in compliance with safety, regulatory expectations, and cGMP.

• Minimum of 10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial‑scale manufacturing; lesser experience may be considered under extraordinary circumstances where high‑level performance has been sustained.
• Bachelor’s degree required; master’s or PhD preferred.
• Process and equipment knowledge of chemical synthesis of active pharmaceutical ingredients.
• Thorough understanding of GMP requirements for a large‑scale manufacturing facility.
• Demonstrated leadership skills.
• Excellent oral and written communication skills.
• Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not sponsor work authorization or visas for this role.

• Process validation, cleaning validation, and commercialization experience.

• Occasional travel required (5–10%).
• Required to be working onsite.
• Required to be on call. Shift work may apply.

The anticipated wage for this position is $66,000 – $209,000. Full‑time employees are eligible for a company bonus, a company‑sponsored 401(k) plan, pension, vacation benefits, medical, dental, vision, and prescription drug benefits, flexible benefits (e.g., dependent day care), life insurance, death benefits, certain time off and leave of absence benefits, and well‑being benefits (e.g., employee assistance program, fitness benefits, employee clubs and activities).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. 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.

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