Director, External Supply Leader (DS/DP)

Location: US onsite (Princeton, NJ, Menlo Park CA, Miami, FL) or Oxford, UKOverview of Role: Director, External Supply Leader (DS/DP) will support development of the strategy and lead/participate in the execution of Summit’s global supply chain plans for commercial product(s). This role is pivotal in ensuring the efficient and compliant delivery of high-quality pharmaceuticals to customers worldwide. The successful candidate will oversee the activities related to the external manufacture of drug substance and drug product batches for clinical and commercial programs in US and global markets, lead the strategic and tactical related aspects of Summit’s engagement with external manufacturers and operational partners from a business perspective, including managing day to day vendor relationships to further DS/DP batch production activities.Roles and Responsibilities:Manage and oversee production at 3rd party /contract manufacturing organizations (CMO’s) from a business and operational perspective.Responsibilities include, but not limited to ensuring quality and compliance, managing the DS/DP CMO’s, lead forecasting discussions and alignment with forecasting terms in contracts, ensuring schedule adherence, and all activities related to business/tactical aspects (quotes, PO’s, invoices etc.) of ensuring a DS/ DP batch is manufactured on-time to the schedule by the planning teamCollaborate with internal teams to ensure all production-related goals are met.Act as the main business point of contact for ongoing supply related activities with drug substance and drug product vendors to ensure on time delivery of batches for forward processing to the next manufacturing node.Support the implementation of the global supply chain strategy to further clinical and commercial goals, including product availability, cost optimization, and customer satisfaction.Collaborate with CMC/ Tech Ops, Procurement, Commercial, Finance, QA and operational teams, ensuring high levels of compliance, performance, and alignment with business objectives.Drive continuous improvement initiatives in collaboration with wider teams to enhance supply chain efficiency, sustainability, and resilience in the DS/DP domain.Ensure the forecasted demand is aligned with production capabilities, optimizing inventory levels and minimizing excess or shortage at DS/DP vendors.Ensure that the DS/DP CMO’s are executing to the operational forecasts and plans as directed by the cross functional teams.Lead or participate in quarterly or bi-annual business review meetings with the assigned vendors, ensuring appropriate KPI’s being agreed to with the CMO’s and adherence to the same.As needed, support long term strategic activities for supplier selection, negotiation, operations and performance management to ensure that partnerships align with organizational goals.Manage any third-party manufacturers (CMOs), as assigned and logistics providers to ensure the highest standards and adherence to timelines.Proactively identify and resolve issues within the supply chain that could affect the delivery of commercial products.Lead efforts to streamline processes, reduce lead times, and improve cost-efficiency without compromising product quality.Ensure that all commercial supply chain activities comply with relevant regulatory requirements, including cGMP (current Good Manufacturing Practices), GDP (Good Distribution Practices), and country-specific regulations.Stay current with industry trends and evolving regulatory standards to ensure compliance and alignment with best practices.All other duties as assigned.Experience, Education and Specialized Knowledge and Skills:Qualification: Bachelor’s degree in Science, Engineering, Operations, or a pharmaceutical industry related field.MBA or advanced degree in Science, or a related field is preferred.At least 12 years of experience in global supply chain management and manufacturing operations in the pharmaceutical/ biotech area with specific focus on biologics manufacturing and management of DS/DP CMO’s.Extensive experience in managing the business and supplier relationships of CMO’s in the Drug Substance/ Product area, and new product launches, PAI readiness, contract negotiations, establishing business processes for inventory management at vendors and manufacturing operations.Proven experience working with third-party manufacturers (CMOs) and logistics providers, ensuring quality standards and on-time delivery.Deep understanding of regulatory and compliance standards in the biotech industry (e.g., cGMP, GDP, and other global regulations).Strong experience in managing global/ virtual teams and driving cross-functional collaboration.Excellent analytical and problem-solving skills with the ability to make data-driven decisions. Strong communication skills, both verbal and written, with the ability to convey complex ideas clearly and effectively.Ability to thrive in a fast-paced, dynamic environment, managing multiple priorities simultaneously.The pay range for this role is $184,000-$230,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.

Salary : $184,000 - $230,000