Associate Director, External Manufacturing & 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 Packaging documentation including but not limited to batch records, BOM's, specifications, artwork, and change control
• Support process/product packaging 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 for Packaging
• 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

Requirements

• Education & Core Experience
• 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 molecules is required, and experience in Packaging production is required
• 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
• Hands-on investigations/RCA (OOS/OOT/deviations) and continuous improvement at external sites
• 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
• #LI-HYBRID
• Pay Range:
• Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
• Our passion is anchored in rob

Benefits

Additional Information

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. As the Associate Director, External Manufacturing and Supply Operations for Packaging, 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.

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