Technical Field Specialist-Avid Radiopharmaceuticals

Source: https://careers.lilly.com/job/philadelphia/technical-field-specialist-avid-radiopharmaceuticals/410/4689713
Application Deadline:


Type

Corporate / management

Location

Country: United States

City: Philadelphia

Type

Corporate / management

Location

United States

Philadelphia

The Technical Field Specialist position is based at Avid Radiopharmaceuticals in Philadelphia, Pennsylvania and supports US Amyvid commercial manufacturing operations. The US Amyvid commercial manufacturing network consists of multiple contract manufacturing sites located in select geographic locations to provide delivery of Amyvid to patients. Amyvid is a Positron Emission Tomography (PET) imaging agent that is manufactured, tested, released, delivered, and administered within the same day. This position liaises with Avid CMC/development, Amyvid commercial operations, and our contract manufacturer(s) to ensure Amyvid is safely and reliably manufactured with quality always. Responsibilities include: Obtain, expand and maintain full understanding of Amyvid manufacturing and analytical procedures Conduct technical site visits to contract manufacturing organization (CMO) facilities to observe production and testing of Amyvid Train, educate, and collaborate with contract manufacturing organization (CMO) site staff during technical site visits Review completed manufacturing batch documentation Reconcile and identify trends in batch manufacturing data to realize previously unidentified process improvements. Coordinate projects to roll out process improvements at the CMOs Support start-up activities for new manufacturing sites Coordinate activities to support the supply of critical materials for Avid products Write standard operating procedures and technical reports for protocols Modify CMO manufacturing and QC documentation and coordinate change controls Identify best practices and areas for improvement at CMO sites (e.g. from technical site visits or batch record review) and collaborate with Technical Operations, responsible Project Managers, and CMC/development functions to replicate (if best practice) or find a solution (if area for improvement) Maintain a working knowledge of applicable Federal Regulations (for example 21 CFR 212)