Provide GMP quality oversight for outsourced manufacturing across cell bank, drug substance, drug product, packaging, labeling, and distribution.
Collaborate with cross-functional teams to ensure timely batch disposition, compliant documentation, and proactive quality risk management.
Lead quality record review, manage CDMO relationships, and support regulatory inspections and filings.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. As a company launched from Paragon Therapeutics, it is in early clinical and preclinical stages with a focused pipeline.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Lead day-to-day oversight of commercial manufacturing operations, process engineering activities, and continuous improvement initiatives.
Drive process optimization, troubleshooting, scale-up, PPQ, validation, and lifecycle management activities for commercial products.
Support regulatory CMC strategy, including development and review of Module 3 CTD submissions and health authority responses.
Deciphera Pharmaceuticals is committed to improve the lives of people with cancer. They offer a dynamic team environment and opportunities for personal and professional growth.
Develop and execute QC strategy to support clinical product testing and commercial launch.
Lead and provide oversight of analytical method validation and lifecycle management.
Lead complex investigations and champion data integrity principles.
Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka is building its core team and is looking for top talent who are passionate about making a difference.