GENERAL SUMMARY:

The Associate Director is responsible for managing the operations of Vertex’s external commercial network which includes Drug Substance, Drug Product Intermediate and Drug Product manufacturing, working in the External Manufacturing Operations team. Managing the external manufacturing network is a critical component of the Commercial Manufacturing and Supply Chain team’s role in ensuring that the company effectively and efficiently delivers medicines to patients. The Associate Director provides vision, leadership, and both strategic and enterprise thinking in the management of the external partners. This leader will also cultivate and leverage multiple cross-functional business relationships to identify and execute creative solutions to organizational opportunities and challenges. The Associate Director of External Manufacturing reports directly to the Senior Director, External Manufacturing. This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will be accountable for a specific CDMOs external commercial manufacturing operations activities across all phases for small molecules. This role will partner closely with colleagues across Vertex to ensure seamless supply of all commercial products manufactured at the CDMO. The candidate will be in a hybrid role (3 days/week onsite), with travel to CDMO sites, as necessary.

KNOWLEDGE AND SKILLS:

• Understanding of the science and technology underlying small molecule manufacturing as well as analytical techniques that support commercial manufacturing activities.
• Demonstrated understanding of the principles and applications associated with commercial manufacturing operations, maintenance, and engineering.
• Strong knowledge of cGMP requirements.
• A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Understanding of the technical aspects of manufacturing, testing, and controls, the regulations governing pharmaceutical operations, as well as financial systems and controls.
• Excellent communication and interpersonal skills with the ability to work in strong cross-functional relationships and communicate complex issues and concepts enterprise-wide, from the executive team to the manufacturing floor.
• Excellent team player and be able to build and sustain organization respect and trust at all levels.
• Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them.
• Resilient and able to work well in a demanding, fast-paced entrepreneurial environment.
• Sound judgment and business acumen with personal versatility and flexibility as business and team evolve.
• Keeps current on professional knowledge, expertise and best practices.

EDUCATION AND EXPERIENCE:

• BS or MS or PhD in Chemical Engineering, Chemistry or related discipline
• BS and 8+ years of experience (6+ years with Masters, 4+ years with PhD)
• Previous experience working on process development, optimization and commercialization of drug substance and drug product

• Acts as main point of contact for CDMO(s) including leader of CDMO working teams and strategic business review chairperson.
• Responsible for Long Term Strategic supplier management and accountable for Supplier Relationship Management (SRM) and SRM related processes for given CDMOs.
• Responsible for driving execution of commercial production plans: Provide operational oversight and troubleshooting support to ensure all deliverables meet or exceed Vertex requirements (including but not limited to successful execution of manufacturing operations, on-time shipments, quality compliance and cost management).
• Responsible for driving execution of the production plan at CDMO. (PO through delivery).
• Partners with MS&T, Quality and CMSC Strategy and Business Operations to champion a culture of quality with our CDMO’s and to ensure that all activities and documentation comply with regulatory requirements.
• Establish a robust tracking and reporting process to monitor CDMO performance using a set of standard KPIs (Key Performance Indicators) and report progress to management.
• Leads identification and resolution of business/contract issues (bring in legal, CMSC LT, Strategy +Bus Ops, Strategic Sourcing)
• Partners with Vendor Management, Strategic Sourcing and Strategy and Business Operations to further develop our Supplier Relationship Management and Supplier Contracting Programs.
• Partners with Global Supply Chain to develop long-term manufacturing network strategy and to maintain a flexible, reliable, robust, and cost-effective manufacturing network.
• Champions a strong winning culture, fostering teamwork and commitment to excellence through transparent communication.
• Ability to travel, international, up to 40%.