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Technical Field Specialist-Avid Radiopharmaceuticals United States,
Posted on : 18 May 2017
Req ID 33440 Title Technical Field Specialist-Avid Radiopharmaceuticals City Philadelphia State / Province Pennsylvania Country United States Company Overview Avid Radiopharmaceuticals, Inc. (Avid RP), a wholly owned subsidiary of Eli Lilly and Company, is a molecular imaging company developing novel PET imaging agents with the potential to aid in diagnosis, treatment selection and therapeutic monitoring of serious diseases. We unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We re looking for people who are determined to make life better for people around the world. Responsibilities 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 proceduresConduct 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 visitsReview 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 CMOsSupport start-up activities for new manufacturing sitesCoordinate activities to support the supply of critical materials for Avid productsWrite standard operating procedures and technical reports for protocolsModify 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) 33440BR Basic Qualifications Bachelors in Chemistry, Engineering, or other scientific or related fieldPharmaceutical industry or contract manufacturing experienceQualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Additional Skills/Preferences Working knowledge of cGMPs in a commercial pharmaceutical manufacturing environmentAbility to travel domestically and support off hour (early AM) manufacturing during technical site visitsSuperior software skills (e.g. Excel, Word, Project, Access)Desire to work as a collaborative team member.This position will be based out of Philadelphia, Pennsylvania at Avid Radiopharmaceuticals, Inc.Experience with radiopharmaceutical synthesis (experience in PET drug radiosynthesis desirable)Strong written and verbal communication skillsProficient organizational skillsAbility to prioritize multiple issues and projects with competing priorities while working independentlyCuriosity and drive to learn new processes and technologies Additional Information Travel Requirements (approximately 25%)Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Pennsylvania, United States
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