Associate Director, External Manufacturing And Supply Operations

Associate Director, External Manufacturing and Supply Operations

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.

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

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.

Responsibilities

• Build and maintain productive relationships with external contract manufacturers (CMO's), and internal global colleagues
• Ensure timely and effective execution of all manufacturing and supply plans at assigned CMO's
• 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
• Support logistics, transportation and import/export activities
• 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
• Support product qualification activities including but not limited to reviewing/approving IQ/OQ/PQs, stability, and validation protocols; review and approve change controls
• Play a key role in supporting selection and onboarding of new CMOs, technical transfers, operationalizing product supply and site establishment
• Manage and track inventory, perform inventory reconciliations, and support month end close process.
• Issue purchase orders, and track invoices and budgets
• Maintain production schedules and track batch record execution in coordination with Quality
• Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation
• Proven risk management acumen with a continuous improvement mindset
• Where necessary, provide input to the manufacturer and QA for evaluation of process deviations and assist in the investigation of product complaints
• Build and maintain strong partnerships and provide effective communication with all internal and external stakeholders and lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded
• Responsible for scheduling and maintaining routine business operations meetings with CMO's
• Support Regulatory submissions and CMC as required

Qualifications

• BS/BA Degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent desired
• 10+ years combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry, preferably within biotech/pharmaceutical industry
• cGMP career experience embedded in a pharmaceutical manufacturing plant is essential – with first-hand knowledge of plant operations, with the insight to assess performance, and diagnose issues directly at the source
• Technical background with knowledge of engineering and pharmaceutical manufacturing processes in small molecule is required, and experience in DS/API production is desirable
• Excellent problem-solving skills, with the ability to address complex challenges under time pressure
• Demonstrated expertise in risk management, with a history of successfully implementing risk mitigation strategies
• The ability to function in a fast-paced, high-growth, entrepreneurial environment
• Ability to travel domestically and internationally ~25%
• Position requires a strong working knowledge and understanding of both regional and international regulations by government agencies affecting the pharmaceutical industry (CFR's, EU GMP, ICH)
• Timely and effective communication across multiple audiences, both verbally and in writing