Associate Director, External Manufacturing and Supply

<div class="content-intro"><p>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.</p></div><p>Job purpose</p> <p>As the Associate Director, External Manufacturing and Supply Operations, you are responsible for operational execution of external manufacturing and related supply activities. This is a central role within Manufacturing and External Supply Operations and requires the ability to manage multiple activities simultaneously, balancing priorities, with a strong sense of urgency, ability to work with ambiguity, and attention to detail. This position will have you collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply plans for both clinical and commercial supply. You will report to the Director, External Supply Operations.</p> <p><br>Responsibilities</p> <ul> <li>Build and maintain productive relationships with external contract manufacturers (CMO’s), and internal global colleagues</li> <li>Ensure timely and effective execution of all manufacturing and supply plans at assigned CMO’s</li> <li>Develop and manage production processes to support operational execution, including BOM’s, specifications, CAPA’s, change controls, master data, and artwork. Familiarity with ERP/MRP systems</li> <li>Support logistics, transportation and import/export activities</li> <li>Act as the manufacturing and supply chain representative for review and approval of documentation including but not limited to batch records, BOM’s, specifications, artwork, and change control</li> <li>Support product qualification activities including but not limited to reviewing/approving IQ/OQ/PQs, stability, and validation protocols; review and approve change controls</li> <li>Play a key role in supporting selection and onboarding of new CMOs, technical transfers, operationalizing product supply and site establishment</li> <li>Manage and track inventory, perform inventory reconciliations, and support month end close process.</li> <li>Issue purchase orders, and track invoices and budgets</li> <li>Maintain production schedules and track batch record execution in coordination with Quality</li> <li>Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation</li> <li>Proven risk management