Director, Analytical Development & CMC Compliance

Job description

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. The Director, Analytical Development & CMC Compliance is a strategic technical subject matter expert (SME) supporting analytical development roadmap establishment, analytical process optimization, and continuous improvement. The position acts as a technical leader and subject matter expert (SME) in CMC analytical development strategy from tox to Phase 1 through Phase 3 to support global regulatory filings (IND, IMPD, NDA, MAA, etc.). Leads the development, qualification, and lifecycle management of analytical methods and control strategies aligned with ICH guidelines and evolving regulatory expectations. Ensures robust, compliant analytical control strategies to enable success...