AMVETS Jobs

Reference #: 394169 Site Name: Upper Merion Posted Date: Apr 12 2024

Work closely with internal stakeholders to manage and align end-to-end planning activities for sterile clinical drug product manufacturing. Ensure successful delivery and execution of the early phase R&D sterile drug product portfolio.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

Scheduling/Planning: Manage the manufacturing schedule for the Pilot Plant and support planning needs for Parma. Accountable to the UM and Parma site heads. Leads clinical Sterile Drug Product and internal manufacturing demand planning contact for, small molecule (including ViiV) and Biopharm teams. Review IRM data to confirm PP and resource forecasting. Ensure schedule at Parma and UM allows for balanced PP utilization and appropriate for project demands and timelines. Oversight of all clinical Sterile Drug Product and internal manufacturing demand planning meetings with CMC project teams. Delegate for Sterile Clinical Operations at Supply Chain board. Manage and submit site's capacity to global supply chain for short term and long-term planning. Provide routine demand updates to Big Plan and communicate to Development teams. Ensure rolling production plans are revised to customer's latest demand.

Materials Management: Ensure raw materials are available for manufacturing activities. Work with Materials Management to order key components (Stoppers/vials/ raw materials etc). Ensure timely maintenance of planning related business master data is compliant and accurate to facilitate smooth operations in accordance with Global Standard Operating Procedure (GSOP) and Local Standard Operating Procedure (LSOP) and standards. Logistics/Shipping: Manage shipping and receiving activities at Upper Merion (UM) and R&D shipments to and from Parma, Italy. Manage, resolve and/or escalate issues promptly to ensure that the site executes and delivers in accordance with production and shipment plan.

Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: A bachelor's degree in science of Pharmaceutical Product development. 3+ Years of relevant experience in a Manufacturing environment Experience in drug product development and pilot plant operations.

Preferred Qualifications: If you have the following characteristics, it would be a plus: Masters degree in science of Organzational and Development and Leadership. Experience in Drug Product Manufacturing for clinical or commercial supplies. Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.

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