Director, Parenteral Sterility Assurance

LI Test Company(3 months ago)

Indianapolis, IN, United StatesOnsiteFull TimeSenior$133,500 - $246,400Sterility Assurance

About this role

This role provides oversight and drives harmonization of sterility assurance technical programs and control strategies across the Lilly Parenteral Network. The position influences site and global stakeholders, builds sterility assurance capability at sites, and supports PR&D, contract manufacturing, and non-sterile API manufacturing as needed. It also represents Lilly externally on sterility assurance technical and regulatory matters.

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Required Skills

Sterility Assurance
Environmental Monitoring
Data Analysis
cGMP
Regulatory Compliance
Root Cause
CAPA
Technical Leadership
Inspection Readiness
Mentoring

Qualifications

BS Degree
MS Degree Preferred
PhD Preferred

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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