Lexington, Massachusetts16 days ago
div>Reporting to the Associate Director, Quality Control Stability and Trending, the Manager, Quality Control Operations will be responsible for day-to-day oversight of routine batch testing at contract and internal Kiniksa testing laboratories.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Waltham, California16 days ago
p>The Director, Quality Control – Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4. Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
Andover, Massachusetts30+ days ago
To accomplish this mission, we partner closely with transplant stakeholders worldwide and help expand their access to healthy donor organs, while delivering the highest quality technology, service, clinical care and outcomes. This position is responsible for, but not limited to, the following:
- Overall management of quality control activities; oversee the development and implementation of robust systems and procedures to ensure evaluation, measurement and improvement of processes.