Director, Commercial Supply Chain

Overview

Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it. We imagine a world where cancer is a curable disease.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold and Innovative.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other

People are at the center of everything we do, and when it comes to our employees, we make it personal With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.

Join us, as we reshape the future.

Job Summary:

This is a strategic Commercial Supply Chain position within the Supply Chain function and is the accountable owner for developing and executing the commercial planning processes with the overall objective to evolve the function and ensure the success of future product launches. Success in this role will depend on an understanding of commercial demand planning, inventory management, supply planning, and new product launch as part of the overall planning process at a manufacturing site. In addition, daily management of business relationships between Replimune's 3PL, and couriers, and strong collaboration with multiple functions within Supply Chain (supply chain planning and warehouse logistics), Manufacturing and Commercial Operations across the organization as part of the overall Supplier Relationship Management process.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

The Director of Commercial Supply Chain will be responsible for the serialization, packaging and labeling operations internally; capacity modelling to recommend scheduling strategies, future capacity needs, and capacity utilization strategies, working in conjunction with the Clinical Supply and Warehouse Supply teams to establish operating principles at the Framingham manufacturing site to ensure robust communication and alignment for capacity planning, slot allocation, and scheduling to support commercial product launches.

Areas of Responsibility:

Commercial Serialization, Packaging and Shipping Operations

• Leading and managing the entire packaging and labeling process, ensuring compliance with regulations and standards.
• Overseeing the operational aspects of commercial supply labeling, including serialization, label copy, draft labeling, proofreading, electronic and hard copy file maintenance, and distribution of approved materials
• Working knowledge of FDA regulations related to New Drug Applications, Good Manufacturing Practices, and Product Packaging and Labeling
• Develop, lead, and implement optimal packaging solutions along with ensuring proper testing and analysis to assess the packaging's performance, including durability, safety and environmental impact, globally
• Responsible for proper serialization coding, barcoding and GTIN numbers globally, per current regulations and standards
• Lead and manage technical transfers, validations and qualifications of new packaging processes
• Schedule and determine appropriate batch size and process improvements
• Manage day to day activities with commercial supply chain team

Sales and Operations Planning (S&OP)

• Collaborate with the Clinical and Warehouse Supply Chain teams to establish the strategic production planning activities (long-term demand and supply planning) as the input for the strategic operational (CMO capacity planning) and procurement planning.
• Work closely with Commercial Operations to translate demand plans and market analytics into actionable and robust commercial supply plans as an output of S&OP.
• Work closely with 3PLs to ensure supply plan for commercial product is available based on demand planning.
• Work closely with Finance to align the monthly supply plan to financial considerations and metrics
• Responsible for developing, coordinating, prioritizing, and maintaining the S&OP commercial strategy, outlining the future state S&OP process and specific projects and initiatives within this area.Own and generate monthly commercial supply plans for internal cross-functional review and external supplier review.
• Own and manage monthly S&OP metrics development, implementation, monitoring, and reporting.

Supplier Relationship Management (SRM)

• Work cross-functionally to develop targets for the commercial suppliers' metrics and KPI dashboards, working with a cross-functional team; to be utilized within existing Quarterly Business Reviews (QBR) and new Supplier Relationship Management governance process.
• Develop and Manage 3PLs business relationships monitor the performance of the suppliers, and serve as the primary point of escalation for risks and issues.
• Monitor and ensure 3PL adherence to contractual commitments, obligations, and processes, including milestone dates, financial terms, and production schedules both internally and externally.
• Manage budget responsibility for Supply Chain in the region, including logistics, supplier, and headcount expenses
• Develop a highly motivated and cohesive team that will accomplish long-term business objectives and prepare for future growth by identifying, recruiting, and retaining quality staff to support business growth
• Ensure all commercial supply chain activities comply with all applicable laws, regulations, GMP/GDP, and internal company policies.

Qualifications

Education:

• Bachelors Degree required, preferably in life sciences or business

Required Experience:

• 7 - 15+ years of experience in a supply chain management role in an established biopharmaceutical company.
• Experience in leading and developing teams to deliver on organization growth initiatives.
• Experience in managing and implementing SRM and S&OP processes and leading cross-functional teams to overcome hurdles and deliver project results on time and as expected.
• International experience working with all organizational levels from multiple geographic locations.
• Strong knowledge of supply chain processes and experience in supply chain systems (ERP, Traceability tools, Supply Chain Planning Modules, etc.).
• Understanding biotech/pharma manufacturing operations, commercial launch, and supply chain operations.
• Ability to develop and lead a team, manage and resolve conflicts, and influence others through effective communications and relationships across diverse Ionis functional areas & internal/external customers.
• Understanding of the new product introduction aligned to both S&OP and SRM.
• Highly experienced in supply chain strategic analysis and skilled at recognizing complex information arrangements to develop observations and recommendations that assist in the strategic Commercial Supply Chain decision-making processes.
• Ability to work on discrete and ad-hoc Commercial Supply Chain strategic initiatives as directed

About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune's proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.

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