Advisor - Technical Steward - TSMS

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, Texas. This facility is intended to provide APIs for current and future products, including new modalities. It is a unique opportunity to be part of the startup team for a greenfield manufacturing site, and the successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations. 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. Interaction may be required with other Lilly site/contract producers of Lilly products. This position requires comprehensive knowledge of the pharmaceutical industry, Good Manufacturing Practices (GMP), regulatory requirements, and the essential role scientists play in making medicine and creating real‑world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule or peptides/oligonucleotides. Key Responsibilities Provide technical oversight and stewardship for one or more molecules manufactured at the Lilly Houston facility. If necessary, lead the technical transfer of processes from one production facility to another, anticipating and addressing complex scale‑up issues. Provide mentorship and scientific expertise to Process Team members, monitoring, trending, and analyzing production data. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations. May present process data and analyses with Process Team members at Manufacturing Process Team meetings. Drive solutions impacting results across sites or functions. Author technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies. Review/approve Annual Product Review and present annual Global Product Assessment for stewarded molecule(s). Lead resolution of technical issues including those related to control strategy and manufacturing. Troubleshoot issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipate and resolve key technical or operational problems that impact function or geography. Communicate issues in a timely manner. May lead process‑related investigations and assess technical impact. Influence complex regulatory or technical issues within the TSMS area/function. Influence others to adopt a different point of view on difficult concepts. Write standard operating procedures as they relate to the activities of the TSMS group. Review and approve manufacturing batch records and other manufacturing documentation. Work with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor. Assist in process‑related training of Manufacturing Process Team members. As required, directly gather additional supporting data on the manufacturing floor. As required, design laboratory experiments in support of process troubleshooting and/or continuous improvement and execute or coordinate execution in outside laboratories. Help to define and implement medium to large continuous improvements to manufacturing processes. Work with Manufacturing to support the start‑up and validation of new facilities and the associated process equipment. Help to define and implement control strategies for Lilly Houston processes. Lead post‑launch technical agendas and deliver projects that drive substantial step changes in Manufacturing. 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 safety and regulatory expectations as well as cGMP. Minimum Requirements Minimum of 10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial‑scale manufacturing. Lesser years of experience will be considered under extraordinary circumstances or where consistent high‑level performance measures have 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 communication skills, both oral and written. Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role. Additional Preferences Process validation, cleaning validation, and commercialization experience a plus. Other Information Occasional travel required (5–10%). Required to be working onsite. Required to be on call. Shift work may apply. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. 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. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $117,000 - $189,200. Full‑time employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefits program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits such as healthcare and day‑care flexible spending accounts; life insurance and death benefits; certain time‑off and leave of absence benefits; and well‑being benefits such as employee assistance program, fitness benefits, and employee clubs and activities. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #J-18808-Ljbffr Eli Lilly and Company