Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Houston, TX. 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 to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Position Overview:The Analytical Molecule Steward is a senior technical leadership role responsible for building and standing up Drug Substance (DS) analytical capability at the Lilly Houston site - a greenfield API/oligonucleotide manufacturing facility in startup phase. This role leads the technical transfer, method implementation, and analytical control strategy definition needed to introduce oligonucleotide and small molecule DS analytics to Houston, working closely with the site QC team, TS/MS, engineering, and central governance groups to ensure the site is ready to support process validation and commercial manufacturing.
Beyond site startup, the Analytical Molecule Steward serves as the network-level analytical steward for assigned molecule(s), with a particular near-term focus on oligonucleotide products as Houston brings its first commercial molecules online. In this capacity, the role owns the analytical control strategy lifecycle for the molecule(s), partners with the TS/MS Molecule Steward and Regulatory representatives, and represents Houston in network-level analytical governance forums. Candidates with commercialization experience - having taken a molecule from development/technical transfer through to commercial release - are strongly preferred, given the dual site-build and molecule-stewardship nature of this role.
The Analytical Molecule Steward provides technical mentorship to the Site Analytical Steward and broader QC lab staff, and is expected to be the senior technical voice representing analytical sciences within relevant Houston leadership teams (e.g., the Science/Analytical Leadership Team and, where applicable, the Commercialization Lead Team).
Key Responsibilities:
Site Startup & Analytical Control Strategy- Lead the technical transfer and startup of DS analytical methods into the Houston site, including defining technical transfer and knowledge-build strategies for oligonucleotide and small molecule modalities.
- Define and own the analytical control strategy for assigned molecule(s) through each step of the manufacturing process, leveraging knowledge of development, manufacturing, and regulatory expectations.
- Partner with Technical Services/Manufacturing Science (TS/MS), Engineering, and site leadership to define equipment, method, and infrastructure requirements needed to support site readiness and process validation timelines.
- Author and maintain global/registered content methods, method packages, regulatory submissions, and responses to regulatory technical queries (RTQs) for assigned molecule(s).
- Own and/or review molecule-related documents, including material specifications, product comparability study reports, and the analytical section of the integrated control strategy document.
- Own the reference standard control strategy for assigned molecules(s), partnering with CRSO on re-evaluation, replenishment, and replacement testing.
Network Stewardship & Governance- Serve as the network-level analytical steward for assigned molecule(s), maintaining strong connectivity with TS/MS global product stewards and molecule stewards at other network sites.
- Represent Houston QC analytical sciences in relevant network governance forums (e.g., stewardship workstreams, technical review boards) and ensure Houston stays connected to global AQCO initiatives.
- Ensure comprehensive analytical technical review of site Annual Product Reviews (APRs), Yearly Batch Production Record Summaries (yBPRS), Annual Method Periodic Reviews (AMPRs), and Quality Product and Process Assessments (QPPAs) once the site is operational.
- Identify key capability/technology gaps at the Houston site and champion investment to close them.
- Support regulatory audits and due diligence visits as required.
Leadership, Mentorship & Collaboration- Provide technical mentorship and coaching to the Site Analytical Steward and QC analysts; contribute to site QC Talent Assessments.
- Provide technical guidance for analytical investigations and deviations, and lead major deviations as the site scales toward commercial operations.
- Provide analytical sciences representation on relevant Houston leadership teams and drive implementation of the analytical technical agenda.
- Maintain strong partnerships with Platform and Technology Stewards (e.g., PAT, Bioassay, Micro/Endo, Cleaning) to ensure alignment with Houston molecule needs.
- Lead or co-lead relevant AQCO/network stewardship workstream initiatives as Houston capability matures.
Key Attributes & Skills
- Broad knowledge of analytical control strategies and technologies across oligonucleotide and/or small molecule modalities.
- Deep technical expertise in analytical chemistry and advanced analytical technology (e.g., UPLC, GC, LC-MS, IP-RP-HPLC, CE/CGE, FTIR), with strong understanding of how analytics connect to manufacturing operations and site startup activities.
- Demonstrated expertise in analytical investigations, forensics, and troubleshooting of complex technical issues.
- Comfortable operating in an ambiguous, still-forming greenfield site environment - able to build capability and infrastructure from the ground up.
- Strong communication and influencing skills, including the ability to communicate complex technical concepts to site, network, and regulatory audiences.
- Effective mentor for site-based steward(s) and QC analysts.
- Credibility with Site TS/MS and QC Leadership Teams, and with the broader network stewardship community.
- Keen awareness of the current technical and compliance climate within QC, and familiarity with global regulatory standards (e.g., ICH, USP, Ph.Eur.) and compendial methods.
- Strong organizational and project management skills, particularly in a startup/site-readiness context.
Basic Requirements:
- Advanced degree (Ph.D. or Master's) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field is preferred but not required - significant industry experience may offset a Bachelor's-level degree.
- 8+ years in analytical sciences within pharmaceutical manufacturing, with experience in method development, validation, and lifecycle management for drug substances.
- Experience with technology transfer, equipment qualification, and method transfers across sites, including regulatory submissions, audits, and compliance requirements.
Additional Preferences:
- Experience with oligonucleotide analytics (e.g., IP-RP-HPLC, CE/CGE, LC-MS sequence/impurity characterization) strongly preferred; small molecule/separations and spectroscopy experience also valued.
- Commercialization experience preferred - having led or significantly contributed to taking a molecule from development/technical transfer through commercial release.
- Proven track record leading cross-functional teams and driving continuous improvement or site-readiness initiatives; startup or greenfield site experience is a plus.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$126,000 - $204,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a 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; and well-being benefits (e.g., 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 and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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