Eli Lilly and Company · 1 day ago
Analytical Technical Steward Peptides and Oligonucleotides
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
$65K/yr - $169K/yr
5+ years expEli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. The Analytical Technical Steward will ensure that analytical testing of products meets both Lilly and external requirements, while also leading investigations and improvements in laboratory processes.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Technical review, interpretation, and release of data including data released from CM, stability, process validation, and reference standard characterization
Utilizes technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence
Develop investigational testing protocols and perform testing as required
Contribute to APR, tech transfer, and process validation as required
Communicate effectively in both written and oral formats within the API EM organization as well as with external customers and business partners
Participate in internal/external audits as needed
Develop and ensure execution of quality plan projects
Coordinate testing needs across sites in support of batch release, stability, process validation, or single batch verification testing
Performs method assessments, with deficiencies and areas for improvement noted within the assessments
Ensure that method validation packages for marketed products are consistent with current regulatory expectations and compendial monographs. This includes evaluating existing method validation data and taking actions to facilitate updating packages as needed
Participates in method validations according to Global Quality Standards (either to bring methods up to current regulatory requirements or to provide additional data to support method changes or changes in practices)
Review of analytical test method packages
Approval of test method protocols
Approval of new test methods or changes or deletions to existing test methods
Provides laboratory support (e.g., method development, validation, and implementation of method improvements) for marketed products (including: laboratory work, training/transfer of new method to QC labs, change controls, and regulatory submissions)
Support technical agenda projects including the implementation of new technologies into QC labs and improvements to existing methodologies
Improve assays in QC. These improvements include variability reduction, method optimization, and new method development
Local and Global Method Change Control Ownership
Oversight of reference standard evaluations per Global Quality Standards
Selection of appropriate packaging materials
Consult in the preparation of the characterization protocol for corporate reference standards
Approve the characterization protocol before the initiation of laboratory testing of candidate materials for corporate reference standards
Participate in the review of the reference standard profile and associated documentation for data integrity
Method transfers to Contract Manufacturers
Oversee transfer of analytical methods for marketed products to CM laboratories or to designated third party QC labs
Monograph review and implementation
Ensures consistent practices between laboratories running the same methods
Effective management of multiple projects
Qualification
Required
Bachelor degree (4 year College) in a science field related to the lab (e.g. Chemistry, Biochemistry, Pharmacy or equivalent experience)
5+ years of industry related experience in pharmaceuticals in a GMP lab (Large Molecule, Peptide, and/or Oligonucleotide strongly preferred)
Demonstrated proficiency in complex laboratory analysis including, but not limited to chromatographic (both HPLC and GC), spectroscopic, bioassay, compendial and LC-MS
Ability to work in a lab environment, including wearing appropriate PPE and following safety guidelines
Deep understanding of compliance requirements and regulatory expectations with demonstrated capability to coach and influence
Demonstrated accuracy and proficiency in analytical skills
Demonstrated strong problem-solving skills
Strong oral and written communication skills demonstrated through documentation and presentations
Demonstrated strong interpersonal interaction skills
Ability to work in cross functional teams as well as across networks
Demonstrated analytical skills
Demonstrated experience with method qualification, validation, and transfer
Proven ability to provide QC support for contract manufacturers of starting materials, intermediates, and APIs to include Large Molecule, Peptide, and/or Oligonucleotides
Proficient in establishment and maintenance of GMP or CS mode analytical equipment, to include computer systems validation (CSV)
Proven ability to support maintenance of Corporate Reference Standards, and manage testing and reporting of results from contract manufacturers
Preferred
Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology
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.
10001+ employees
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
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-06
2026-01-06
Company data provided by crunchbase