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Job Description
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The QC Stability Manager is responsible for leading and supporting GMP large-molecule stability testing across all phases of client programs within QC. This role provides strategic and operational leadership for the QC Stability function and manages a team of QC professionals. The position requires strong experience in QC laboratory operations, stability program management, and a deep understanding of cGMP/GDP requirements.
- Leading analytical methods support activities related to stability testing, product control programs, and reference standard management.
- Oversee daily operations of the QC Stability function in a biopharmaceutical manufacturing environment supporting multiple products and client programs.
- Drive continuous improvement and operational efficiency across stability workflows, systems, and processes.
- Ensure compliant operation and maintenance of stability-related infrastructure, documentation, equipment preventive maintenance, calibration, qualification, and training programs.