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Replimune, Inc. Associate Director, Clinical Supply Chain in Framingham, Massachusetts

Replimune is seeking an individual to join us as Associate Director, Clinical Supply Chain and Logistics with a strong background in immunotherapy trial logistics for this brand-new role. You'll work collaboratively with internal and external stakeholders to design and execute supply chain strategies and manage supply chain partners supporting our immunotherapy products.

The Associate Director, Clinical Supply Chain is responsible for ensuring continuous and cost-effective supply of Replimune products. The Associate Director Clinical Supply Chain will lead a high-performing team and develop robust end-to-end clinical supply chain processes including supply planning, materials management, inventory management, and distribution of packaged products. The Associate Director will use expert knowledge of cGMP regulations and project management to ensure manufacturing materials are available to enable the production schedule. The Associate Director will assist in vendor management for procurement of manufacturing supplies and manage the supply and distribution of key starting materials, such as cell banks and seed stocks. The Associate Director will work with customers (internal and external) and CMOs to oversee forecasting, packaging, labelling and distribution operations and manage drug supply inventory. In addition, the Associate Director will support investigations, drive continuous improvement initiatives, and work to mitigate risks associated with single source suppliers.

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

  • Manages the relationships and activities with all CMOs and internal Manufacturing team.

  • Develop and oversee plans for commercial and clinical RSM, drug substance, drug product, and packaging that results in meeting commercial requirements for assets

  • Responsible for supplying drug product for all company sponsored clinical trials as well as all Investigator Sponsored Trials (IST's)

  • Establish and implement inventory policy and materials risk mitigation strategies

  • Develops and executes Supplier Governance Model at all CMO's to ensure appropriate controls and oversights are in place

  • Responsible for managing internal inventory system.

  • Partner with Quality assurance to ensure outside contractors are in compliance with all cGMP guidelines and SOP requirements

  • Support the financial planning processes (e.g., forecasting, strategic planning) by analyzing raw material and external supply partner requirements (e.g., Drug substance, drug product and packaging demand) on an annual basis and create material budget forecasts for strategic planning

  • Responsible for working with outside packaging graphic design companies to assure all approved artwork is up to date and secured and that any changes that occur are approved by regulatory

  • Responsible for managing the relationship with company 3PL

  • Responsible for global logistics function for movement of all materials

  • Authors and/or reviews pertinent CMC sections for pre and post approval regulatory submissions. (IND, IMPD, NDA, MAA)

  • Work closely with Clinical Operations and key internal stakeholders to ensure Replimune is well positioned to meet clinical program needs and business objectives.

  • Responsible for clinical trial supply continuity, inclusive of Investigational Products, combination medical products, and purchasing and distribution of ancillary supplies

  • Manage finished goods inventory, planning and distribution, both at the depot level and site level, and including interaction with clinical team to track patient enrollment and dosing schedule to accurately adjust site inventory levels and ensure uninterrupted patient access to the therapies.

  • Work with Quality and Clinical Operations partners to manage, track and closeout in-transit and on-site temperature excursions and other shipping and storage deviations, both for finished goods and un-kitted GMP materials.

  • Leads supply chain working group meetings and represents the supply chain function at Study Management Team meetings as required

  • Lead contact / project management for CMO activities (production, shipping of materials)

  • Gather user requirements from key stakeholders to further develop the program inventory and supply management tool for internal communication

  • Work with manufacturing, production scheduler, and QA to ensure schedule for manufacturing meets program needs

  • Develop a rolling demand plan and drive improvement of forecast accuracy via a periodical product demand forecast cycle

  • Collaborate with Clinical Operations to incorporate current clinical results and long-term clinical plan assumptions; monitor the demand plan performance by measuring actuals vs estimates to fine tune the statistical forecasts

  • Monitor, track and proactively manage IMP expiry in close collaboration with Replimune Quality and Regulatory

Educational requirements:

  • BA/BS in Supply Chain/Operations or life sciences/health-related field.

Experience and skill requirement:

  • Minimum of 12 years' experience in supply chain planning within the Pharmaceutical or related industry

  • Expertise in use of MS Excel, as well as demonstrated proficiencies in MS Project, and Visio

  • Understanding of clinical supply chain management and associated resources/tools, for both oral solid product and sterile vials with knowledge of contract

Location Requirements:

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

Requisition ID: 2022-1218

External Company Name: Replimune, Inc.

External Company URL: replimune.com

Street: 33 New York Avenue

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