Chemist – GMP Analytical Testing / Method Support Lilly Medicine Foundry

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 66 000 - 172 000; Plein temps

Résumé du poste

Lilly in Indiana is seeking a chemist with strong HPLC/UPLC and GMP experience to perform routine testing, method development, qualification, and validation in a GMP environment across multiple modalities, supporting cleaning verification and validation from Phase 1 to Phase 3.

This onsite role requires collaboration with Cleaning Validation, Manufacturing, and Quality, with opportunities to grow technical skills at the Lilly Medicines Foundry, a first-of-its-kind facility, and offers a path to

Qualifications

• B.S. or M.S. in a relevant STEM field with required years of experience.
• Hands-on HPLC/UPLC with UV detection experience.
• GMP laboratory experience and data integrity knowledge.
• Authorized to work in the United States full-time.
• Experience with method development/validation preferred.

Responsabilités

• Perform routine GMP testing of swab and rinse samples using HPLC/UPLC with UV detection.
• Support development, qualification, and validation of analytical methods across modalities.
• Execute swab and rinse recovery studies and evaluate method performance.
• Operate, maintain, and troubleshoot HPLC/UPLC instrumentation.
• Handle samples and standards, including high potency compounds, safely.
• Document work in compliance with cGMP and data integrity expectations.
• Perform data review and participate in investigations of out-of-trend results.
• Collaborate with Cleaning Validation, Manufacturing, and Quality teams.
• Contribute ideas to reduce cycle times and improve lab workflows.
• Flex hours to meet operational demands, including weekends/overnight.

Connaissances

HPLC/UPLC with UV detection

GMP laboratory practices

Data review & documentation

Instrument troubleshooting

Residue analysis understanding

Formation

Bachelor's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related STEM

Master's degree in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or related STEM

Outils

Empower chromatography data system

Electronic Lab Notebooks (ELN)

Description du poste

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first‑ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The analytical team supporting Cleaning Validation delivers the timely, reliable results that allow Foundry equipment to be released safely and on schedule. In this role, we are seeking a motivated chemist with a strong foundation in HPLC/UPLC and GMP laboratory practices to perform routine testing and support method development, qualification, and validation in a GMP environment. The work supports cleaning verification and validation across multiple modalities: small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds.

This is a hands‑on, onsite laboratory role that offers the chance to grow technical skills alongside experienced scientists at a first‑of‑its‑kind facility supporting clinical Phase 1 through Phase 3 supply. You will collaborate with the cleaning validation group, Manufacturing, and Quality, and contribute to building a strong culture of safety, quality, and continuous improvement as the Foundry moves from startup to steady‑state operations.

Responsibilities

Top candidates for this position will be expected to:

• - Perform routine GMP testing of swab and rinse samples using HPLC/UPLC with UV detection to support timely equipment release at the tempo of manufacturing, including sample receipt, preparation, analysis, data review, and reporting.
• - Support development, qualification, and validation of analytical methods for trace‑level residues across multiple modalities, including small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds.
• - Execute swab and rinse recovery studies and sample preparation experiments, and evaluate method performance (sensitivity, linearity, accuracy, precision, specificity, and solution stability).
• - Operate, maintain, and troubleshoot HPLC/UPLC instrumentation and chromatographic methods, escalating issues appropriately.
• - Handle samples and standards, including high potency compounds, safely using appropriate containment and HSE practices.
• - Document work accurately and contemporaneously in compliance with cGMP and data integrity (ALCOA+) expectations, and write or assist with analytical procedures, protocols, and reports.
• - Perform data review and participate in investigations of out‑of‑trend or out‑of‑specification results and deviations.
• - Collaborate with cleaning validation, Manufacturing, and Quality partners to understand testing needs and prioritize work against the manufacturing schedule.
• - Contribute ideas that reduce cycle times and improve laboratory workflows, and support laboratory readiness activities such as instrument qualification and method transfer.
• - Flex work hours as needed to meet operational demands, including support during shutdowns, weekends, and overnight operations.

Basic Requirements

• - B.S. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related STEM field with 2+ years of relevant laboratory experience; or
• - M.S. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related STEM field with 1+ year of relevant laboratory experience.
• - Hands‑on experience with HPLC and/or UPLC with UV detection, including sample preparation, instrument operation, and data processing.
• - Experience working in a GMP laboratory environment, with working knowledge of cGMP, data integrity principles, and good documentation practices.
• - 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• - Hands‑on experience with liquid chromatography‑mass spectrometry (LC-MS) for method development or sample analysis.
• - Experience supporting cleaning validation or cleaning verification, including swab and rinse recovery studies and trace‑level residue analysis.
• - Experience with additional detectors such as CAD or ELSD, and with complementary techniques such as TOC, conductivity, UV/Vis, or FTIR.
• - Experience analyzing multiple modalities, including small molecules, biomolecules, peptides, oligonucleotides, and high potency compounds, and familiarity with containment practices.
• - Experience with method qualification or validation and an understanding of residue limit concepts (e.g., health‑based exposure limits and MACO).
• - Proficiency with chromatography data systems (e.g., Empower) and electronic laboratory notebooks.
• - Strong attention to detail, learning agility, and the ability to prioritize laboratory workload and manage ambiguity.
• - Good communication and interpersonal skills, with the ability to work both independently and collaboratively in a dynamic laboratory environment.
• - Interest in applying analytical chemistry through hands‑on laboratory work to solve real‑world pharmaceutical manufacturing challenges and improve patient outcomes.

Other Information

• - Initial location in Carmel, IN
• - Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
• - Position is onsite only and laboratory‑based; remote or hybrid work is not available.
• - Requires flexibility to adjust work hours to meet operational demands, including support during shutdowns, weekends, and overnight operations as needed.
• - Potential exposure to chemicals, allergens, high potency compounds, and loud noises.

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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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.

Actual compensation

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600

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