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Associate Manager, Clinical Supply Chain

Company: Acceleron Pharma
Location: Cambridge
Posted on: April 5, 2021

Job Description:

What's in it for you?. We are seeking an experienced and talented individual who thrives in a dynamic, fast-paced, team-oriented and collaborative environment. In this role, you will assist in managing portions of all aspects of the clinical drug supply chain, including creation, execution/maintenance of the clinical drug supply strategy, supplies and associated documentation. You will collaborate closely with the internal clinical supply chain team, cross-functional team members and CMO/CRO/IRT vendors to help execute the manufacture of supplies. As Associate Manager, Clinical Supply Chain, you will assist in the management of drug product manufacture and label/pack/distribution of clinical supplies at multiple CMOs and assist with development/maintenance of the IRT system with vendors to ensure uninterrupted drug supply for global clinical trials. What will you be doing?. Assist in managing supply chain CMOs to develop labeling/packaging materials, development of compliant country label text and the manufacture, storage and cold chain distribution of clinical trial materials via primary and secondary depots: Serves as the primary Clinical Supply point of contact as the Clinical Supply spokesperson at clinical development- related meetings (i.e. Clinical Supply Team, Clinical Operations Sub Team, and Clinical Development Sub-Team) and CMC product development related meetings. Interacts with various internal teams, Regulatory, CMC, Manufacturing, Safety, Data Management and Quality as necessary to address drug supply related issues. Assist in the set up and implementation of IRT systems for new protocols and maintenance of existing ones, managing threshold levels, generation of manual shipments and disposition of quarantined materials. Help to organize UAT testing of IRT systems at kick off and during system enhancements, as needed, based on protocol changes. Participate in regular vendor meetings for project oversight. Manage and Monitor Drug inventory for study protocols while using vendor proprietary systems for inventory and distribution. Assist in management of multiple CMO vendors/systems, manufacturing supplies to support shelf life retest dating and product expiry management. Collaboration with internal cross-functional groups for proper supply readiness timing representing Clinical Operations, Data Management, Biostatistics, Safety and Quality. Identify, evaluate and request documentation of all Clinical Supply Chain vendors to support filing in the Trial Master File (TMF) and prepare for inspection readiness to meet Acceleron Business needs. Assist in development of Department SOP's, procedures and processes to build a strong Supply Chain infrastructure for building in Quality and inspection readiness. Assist with implementation and development of a department Inventory Management and Forecasting system for clinical demand forecasting for Clinical Supplies and to have a central database enabling inventory management. Assist and manage with our vendors and internally all necessary documents required to be filed in the TMF on a regular and on-going basis. Providing Quality Control checks to verify documents are complete, correct and timely. What are we looking for?: B.A./B.S. with Scientific/Quality/Project Management role within a pharmaceutical sponsor, or related CMO or CRO: Minimum of five (5) years industry experience with two (2)+ years of experience working within global clinical supply chain, either in industry, as a sponsor, vendor or CRO. Experience with biologics and combination drug products (drug + device) is a plus. Experience managing vendors with strong understanding of regulatory requirements and GMP/GCP guidelines governing labeling, packaging and distribution/logistics of clinical trial materials US/EU/ROW/Japan and Global country requirements (FDA/EMA/ICH and MHRA): Knowledge of proper GMP/GXP trial documentation and identify what is required to be stored in the Trial Master File (TMF) regarding Supply Chain documents: Cold chain product management, deep understanding of GMP/GXP requirements and development/implementation of sponsor internal processes & SOP's for greater compliance and efficiencies are a plus: Ability to strategically plan, organize and manage multiple projects simultaneously. Ability to prioritize tasks/issues and identify them in the future, raising awareness to potential issues in a proactive manner. Strong work ethic to meet deadlines and be flexible on the potential occasion you may need to work outside of immediate job role or normal job hours to get the task done and meet the deadline. Ability to creatively solve Supply Chain issues and think outside the box to address issues. Big picture understanding of the complete Drug Supply Chain: Drug Substance/Drug Product/Regulatory Submissions and steps required for compliant Drug Release approvals and Global logistics. Strong interpersonal and organizational communication skills, including planning and execution of meetings and presentations. Effective listening, evaluation of issues and communication of mitigations. Professional, honest, accountable, dedicated. Proficiency in all aspects of Microsoft applications (Excel, Word, PowerPoint, Project, etc.), experience with Veeva Vault and Phlex Global is a plus. Ability to work full-time, on-site/remote or combination of locations during core corporate hours at the Acceleron offices in Cambridge. How will you grow with us?. This position will allow for growth within the role and the company, contributing your valuable experience in establishing Policies and Procedures for the Supply Chain Department during a critical time. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. You will work closely with many cross-functional areas and will be able to contribute to their practices for a more efficient, cost effective and compliant Supply Chain. Our fast-paced environment and hands-on opportunity will challenge you to innovate and learn while having fun with supportive and passionate colleagues. Join our team!.

Keywords: Acceleron Pharma, Cambridge , Associate Manager, Clinical Supply Chain, Executive , Cambridge, Massachusetts

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