Executive Director, Head of Supply Chain

Role Summary:

The Executive Director, Head of Supply Chain is responsible for the management of the clinical supply chain which includes integrated project management of all CMC vendors, shipping international and domestic, storage and clinical distribution, and management of drug product activities for clinical supply. In addition, they are responsible for the build out of a commercial supply chain organization to support and execute the launch of two lead assets. This role is fully accountable for end-to-end clinical supply management in our organization. The position requires a deep understanding of supply chain networks, clinical regulations, commercial regulations, timelines, end-to-end planning and analytics to facilitate communications across a variety of functions and to develop cost-effective clinical supply solutions balancing multiple business objectives.

This role works closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, Commercial and corporate leadership to define and build the capabilities required to effectively manage Dyne’s complex clinical/commercial supply chain and support eventual launch and commercialization efforts while maintaining additional clinical assets.

This role is based in Waltham, MA without the possibility of being a remote role.
 
Primary Responsibilities Include:

• Manage CMOs to deliver study material on time and within budget
• Establish and manage contracts and supply agreements and manage CMOs
• Oversee suppliers and vendors involved in materials planning, inventory control, logistics, distribution to ensure that batch manufacturing is completed on a timely basis
• Lead process improvement initiatives and author clinical supply SOPs
• Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return)
• Responsible for integrated project management of all CMC vendors ensuring all stakeholders support inventory required to fulfill research, pre-clinical and clinical needs
• Responsible for storage and shipping of all pre-clinical and clinical intermediates, domestic and international
• Build a commercial supply chain prior to BLA, and revise for post-BLA improvements
• Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
• Support the development of regulatory CMC documentation and partner due diligence
• Work with partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed and closed within target timeframes

Education and Skills Requirements:

• A minimum of 12 years of relevant biopharmaceutical CMC and/or Engineering experience
• Degree in Business, Engineering, biochemistry, chemistry or similar related field required
• Proven experience in processes and systems to support biopharmaceutical development
• Expertise in investigation of complaints, product rejections, non-conformances, recalls, deviations, and trends from process performance and product quality monitoring and experience implementation of Corrective Actions and Preventive Actions (CAPA) resulting from these investigations
• Knowledge of ERP/MRP computerized control systems, inventory control methods, distribution standard operating procedures, and ex-US clinical supplies management (considered a plus)
• Experience leading contract manufacturing required
• Experience with bioconjugates required
• Strong knowledge of biologics and small molecules manufacturing, materials management, quality control, quality assurance and CMC regulatory requirements
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues, ideally including post-approval experience and international experience and negotiation experience with regulatory authorities on CMC issues related with biologic APIs
• Excellent interpersonal, organizational, negotiations and communication skills; team member than can work collaboratively with colleagues across all functions
• Ability to establish clear expectations and priorities, sets objectives and effectively applies resources
• Ability to set clear goals and consistently deliver
• Flexible and creative problem-solving skills
• Ability to think strategically, to see the big picture, think ahead about ways to do things better
• Think logically, to develop and evaluates options, identify solutions, challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods
• Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill sets to create, influence and negotiate win-win solutions
• Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment

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