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.
p>The successful candidate will work cross‑functionally with Analytical Research & Development, Bioprocess Development, Manufacturing Technical Services, Manufacturing Operations, Regulatory Affairs, and Quality Assurance to drive the transfer, qualification, validation, and lifecycle management of analytical methods for gene‑edited cell therapy products and associated critical materials (e.g., mRNA). In addition, this position will contribute directly to regulatory filings, including specifications, analytical method validation reports, and CMC documentation, and will serve as a QC technical subject matter expert across program teams to ensure compliant, robust, and phase‑appropriate analytical strategies.