Sr. Principal/Advisor – Sterility Assurance

LI Test Company(10 months ago)

HybridFull TimeSenior$114,000 - $198,000Quality / Sterility Assurance

About this role

This role provides oversight and harmonization of sterility assurance technical programs across Lilly’s Parenteral Product Network, ensuring alignment with regulatory and business expectations. The position influences site and global stakeholders, helps build technical capability at manufacturing sites, and supports interactions with external partners and regulatory authorities. It also provides ad-hoc technical support to PR&D, QC Microbiology, contract manufacturing, and non-sterile drug substance manufacturing.

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Required Skills

Sterility Assurance
Microbiology
Quality Systems
Regulatory Compliance
Process Validation
Root Cause Analysis
CAPA Management
Risk Assessment
Data Analysis
Stakeholder Management

+2 more

Qualifications

Bachelor's in Biological Science or Engineering
Master's in Biological Science or Engineering

About LI Test Company

lilly.com

Eli Lilly and Company is a global biopharmaceutical company headquartered in Indianapolis, Indiana. It discovers, develops, manufactures and commercializes prescription medicines across therapeutic areas including diabetes, oncology, immunology, neuroscience and pain, and has a longstanding history in insulin and other major drug discoveries. Lilly invests heavily in research and clinical development and partners with biotech, academic institutions, and industry collaborators to advance biologics, small molecules, and precision medicines. The company operates global manufacturing and commercial networks and provides patient-support programs to improve access to its therapies.

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