Technical Field Specialist
Department: CMC, Manufacturing Operations
Job Title: Technical Field Specialist
Reports To: Associate Director, Amyvid US Manufacturing
Description:
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. For more information, visit www.avidrp.com.
Position Overview:
The Technical Field Specialist is responsible for ensuring the Contract Manufacturing Organizations (CMO) that Avid works with are carrying out the agreed upon commercial manufacturing process for Avid products. The Technical Field Specialist audits CMOs against established manufacturing process and observes quality control test procedures.
The Technical Field Specialist reports into the Associate Director, Amyvid US Manufacturing.
Key Responsibilities:
- Obtain, expand and maintain full understanding of Avid manufacturing and analytical procedures
- Conduct site visits to contract manufacturing organization (CMO) facilities to observe production and testing of Avid products and review for compliance with Avid procedures and PET GMP regulations
- Review completed manufacturing batch documentation and provide appropriate commentary and recommendations Coordinate technical studies to support process improvements at the CMOs
- Interact with and provide technical support to CMOs as needed
- Review and track manufacturing performance data and report results to management
- Write standard operating procedures and technical reviews
- Modify CMO manufacturing and QC documentation and coordinate change control
- Facilitate training of CMO personnel as needed
- Identify technical problems or deficiencies at CMO sites and collaborate with site to find a solution
- Maintain a working knowledge of applicable Federal Regulations (e.g. 21 CFR 212)
Requirements:
- B.S. in Chemistry or related field (advanced degree preferred)
- A minimum of 2 years of pharmaceutical industry experience or equivalent experience
- Experience with radiopharmaceutical synthesis (particularly PET drug radiosynthesis) preferred
- Understanding of cGMPs preferred
- Ability to work independently in a highly focused manner
- Impeccable organizational skills
- Superior written and verbal communication skills
- Excellent computer skills (e.g. Excel, Project, Access)
- Must be willing and able to travel within the USA and worldwide 50-75% of time
Email resume to hr@avidrp.com