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Technical Field Specialist-Avid Radiopharmaceuticals
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.
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
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)
Bachelors in Chemistry, Engineering, or other scientific or related field
Pharmaceutical industry or contract manufacturing experience
Qualified 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.
Working knowledge of cGMPs in a commercial pharmaceutical manufacturing environment
Ability to travel domestically and support off hour (early AM) manufacturing during technical site visits
Superior 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 skills
Proficient organizational skills
Ability to prioritize multiple issues and projects with competing priorities while working independently
Curiosity and drive to learn new processes and technologies
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.