Eli Lilly and Company · 1 day ago
Advisor - Local Site Technical Services Molecule Steward - Small Molecule
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The TSMS Local Site Molecular Steward serves as the technical representative for the Lebanon facility, ensuring robust molecule stewardship and supporting the commercialization of new molecules through collaboration and technical oversight.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
Bachelor's degree in Chemistry, Engineering, Pharmaceutical Sciences, or a related field (Chemistry focus preferred)
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
Preferred
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
Benefits
Company bonus
Company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
Recent News
2026-01-08
2026-01-08
2026-01-08
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