Atsena Therapeutics
11 - 50 employees
🧬 Biotechnology
🏥 Healthcare
💰 $150M Series C - Atsena Therapeutics on 2025-04
Biotechnology • Healthcare
Atsena Therapeutics is a clinical-stage gene therapy company developing first- and best-in-class treatments for inherited retinal diseases. Its lead program, ATSN-201, is in a pivotal Phase 3 trial for X-linked retinoschisis (XLRS); other programs include ATSN-101 for LCA1 (pivotal trial planned), and earlier-stage assets targeting Usher Syndrome 1B and Stargardt disease. Atsena uses proprietary AAV-based delivery platforms — notably the laterally spreading capsid AAV. SPR and a dual vector technology — engineered to address retinal delivery challenges and to enable larger gene payloads. The company focuses on advancing ocular gene therapies through clinical development.
Senior Manager, Clinical Quality Operations
🔥 3 hours ago
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Atsena Therapeutics
11 - 50 employees
🧬 Biotechnology
🏥 Healthcare
💰 $150M Series C - Atsena Therapeutics on 2025-04
Biotechnology • Healthcare
Atsena Therapeutics is a clinical-stage gene therapy company developing first- and best-in-class treatments for inherited retinal diseases. Its lead program, ATSN-201, is in a pivotal Phase 3 trial for X-linked retinoschisis (XLRS); other programs include ATSN-101 for LCA1 (pivotal trial planned), and earlier-stage assets targeting Usher Syndrome 1B and Stargardt disease. Atsena uses proprietary AAV-based delivery platforms — notably the laterally spreading capsid AAV. SPR and a dual vector technology — engineered to address retinal delivery challenges and to enable larger gene payloads. The company focuses on advancing ocular gene therapies through clinical development.
📋 Description
• Responsible for managing Quality project management of Clinical programs • Collaborates with Clinical, CMC, and Nonclinical teams • Ensures compliance with global regulatory requirements • Implements Quality Management System (QMS) • Conducts internal/external audits and GCP/GXP oversight • Escalates quality issues promptly • Promotes a quality culture and Data Integrity
🎯 Requirements
• Experienced in Quality project management of pre-clinical and clinical programs • GXP support expertise • Knowledge of Quality Management System (QMS) • Strength in documentation review and compliance trending • Vendor oversight experience • Familiar with GCP/GXP standards and regulations • Ability to perform GXP risk assessments • Collaborative skills with internal and external teams
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