Lilly
Healthcare
Advisor-TechnicalSteward-TSMS
Neural analysis suggests this role is
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“Advisor - Technical Steward - TSMS at Lilly. Skills: Technical oversight, Process transfer, Manufacturing support. Provide technical oversight and stewardship. Lead technical transfer of processes”
What You'll Achieve.
Enable a successful startup into GMP manufacturing operations; Drive solutions impacting results across sites or function; Deliver projects that drive substantial step changes in Manufacturing
Industry & Context.
Anticipating and addressing complex scale-up issues; Process troubleshooting; Process investigations; Resolving key technical or operational problems
Occasional travel required 5 – 10%, Required to be working onsite, Required to be on call, Shift work may apply
What They're Looking For.
Must Have
10 years of experience in cGMP small molecule, peptide, or oligonucleotide API commercial-scale manufacturing, Bachelor’s degree required, Process and equipment knowledge of chemical synthesis 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
Nice to Have
master's or PhD preferred, Process validation, cleaning validation, and commercialization experience a plus
What You'll Do.
Provide technical oversight and stewardship
Lead technical transfer of processes
Provide mentorship and scientific expertise
and analyze production data
Apply process knowledge and data analysis
Support management of daily manufacturing operations
Author technical reports
Review/approve Annual Product Review
Present annual Global Product Assessment
Lead resolution of technical issues
Troubleshoot issues on manufacturing floor
Anticipate and resolve technical problems
Communicate issues in a timely manner
Lead process-related investigations
Assess technical impact
Write standard operating procedures
Review and approve manufacturing batch records
Ensure successful process knowledge transfer
Assist in process-related training
Gather supporting data on manufacturing floor
Design laboratory experiments
Execute or coordinate laboratory execution
Define and implement continuous improvements
Support start-up and validation of new facilities
Define and implement control strategies
Lead post launch technical agendas
Deliver projects driving step changes
Lead or assist in planning process validation
Own or assist in implementation of change controls
Make decisions impacting a function or geography
Build relationships with partners
Perform job responsibilities in compliance with safety and regulatory expectations
How You'll Work.
Team & Collaboration
Interact with engineering, manufacturing, validation, quality assurance, quality control, development, and regulatory departments; Interaction may be required with other Lilly site/contract producers; Work with Process Team members; Build relationships with internal and external partners
Communication Scope
Excellent communication skills, both oral and written
Process & Methodology
Manage projects, Implement change controls
Full Job Description
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 around the world 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. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. 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. This is a unique opportunity to be a 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. This position 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:** * Provides technical oversight and stewardship for one or more molecules manufa
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