External Manufacturing Associate Director, Drug Product Small Molecule

Role Summary

The External Manufacturing Associate Director leads Vertex's External Manufacturing Organization (ExM) for Small Molecule Drug Product, providing strategic support and enterprise thinking to the Biopharmaceutical Sciences and Manufacturing Operations organization (BSMO). The role cultivates cross-functional relationships to identify and execute solutions for organizational opportunities and challenges, and manages a subset of the Small Molecule Drug Product external network of CMOs. The incumbent partners with key functions to optimize external manufacturing plans and drive reliable, compliant, and cost-effective operations across the external network.

Responsibilities

• In partnership with Supply Chain, MSAT, Quality and Finance, develop external manufacturing production plans and drive plans to execution (on time in full) to ensure a robust supply chain
• Provide operational oversight of, and troubleshooting support to, CDMOs to ensure all deliverables meet or exceed Vertex requirements (including successful execution of manufacturing operations, on-time shipments, quality compliance and cost management) - be Vertex’s eyes and ears at the CDMO for flawless execution of commercial operations
• Optimize tools and streamline processes ExM phases which are employed to support the Operations Model
• Define and build-out dashboard reporting, measuring additional business/supplier KPIs and metrics
• Partner with Analytics & Insights, digital strategy teams and DTE, to build data connections to supplier data
• Define standardized governance processes
• Partners with EXM phase leads in identifying and implementing strategies to enhance efficiency, reduce costs, and drive initiatives for continuous improvement across our external manufacturing network
• Partners with leadership and Supply Chain, MSAT, Finance, and Strategic Sourcing organizations to develop a strategic long-term manufacturing network strategy to maintain a flexible, reliable, robust, efficient and cost-effective manufacturing network
• Support the EXM organization in identifying internal process improvements opportunities, reducing waste and creating efficiencies

Qualifications

• Demonstrated experience in biotech or pharmaceutical industries, in a senior manufacturing leadership role working with or in cGMP facilities within the biotechnology industry.
• Strong quality and compliance background in a commercial GMP biopharmaceutical operations (manufacturing and quality) environment; sound working knowledge of health authority regulations.
• Strong technical background in drug product (small molecule, oral solid dose preferred) manufacturing operations.
• Solid project management skills and experience managing complex projects.
• Strong verbal and written communication skills: ability to expresses oneself clearly and concisely, by adjusting style, language and/or terminology as appropriate for the audience.
• Strong leadership and an innate ability to collaborate and build relationships is critical.
• Ability to work calmly and make sound decisions in a fast-moving environment of uncertainty and change
• Flexibility to work shift hours required to cover critical process steps

Skills

• Strong verbal and written communication skills
• Leadership and collaboration across cross-functional teams
• Project management and cross-functional coordination
• Ability to work calmly and make sound decisions in fast-moving environments
• Strategic thinking and business acumen

Education

• Bachelor's degree in Chemical Engineering, Chemistry or related discipline
• 8 years progressive experience in a management/leadership role in the biotechnology/pharmaceutical industry with a focus on external manufacturing and commercial operations
• Proven ability to support the management of complex budgets, strategic planning and provide analysis of diverse information in a fast-paced environment
• Excellent communication and interpersonal skills, with the ability to influence cross-functional stakeholders and present insights to all levels of senior stakeholders
• Demonstrated continuous improvement mindset, driving efficiencies, process improvements across diverse initiatives
• Strategic thinker with strong results-orientation and sense of urgency to deliver quality results on time and in a highly ethical and professional manner
• A problem solver with a hands-on approach, possessing business acumen and the ability to anticipate business and organizational needs
• Resilient and able to work well in an ambiguous, demanding, fast paced entrepreneurial environment

Additional Requirements

• Travel up to 30% nationally and internationally