Associate, Technical Operations - Radiopharmaceuticals - US Commercial

Role Summary

Associate, Technical Operations - Radiopharmaceuticals - US Commercial. The Technical Operations Associate is responsible for troubleshooting production issues with Commercial US Contract Manufacturing Organization (CMO) sites, assisting with test method and production process changes, tracking production failure root causes, helping to implement improvements aimed at correcting production problems, providing technical input for production changes, and reviewing CMO investigations.

Responsibilities

• Assist/Lead investigations into defects and failures in the field at US Commercial Manufacturing Sites.
• Troubleshoot Quality Control (QC) test method and production issues with CMO sites for the assigned region. Coordinate with the Radiochemistry & Radiopharmaceutical Development and Analytical Development and Quality Control teams as necessary.
• Identify and track root causes for production failures and support programs/solutions to improve site production performance.
• Conduct site visits to assigned CMO sites to troubleshoot issues and/or to observe production and testing of Avid products and review for compliance with Avid approved procedures and PET GMP regulations.
• Assist with supplemental training of CMO site staff during site visits to correct deficiencies
• Assist with roll out of revised major QC test procedures or production processes to CMO
• Lead data analysis projects for batch data for global CMOs for all products
• Create technical summaries and trending reports based off all incoming batch data.
• Support projects related to management of incoming batch data for global CMOs for all products
• Review and assess all changes to technical documents and for process improvement discussions with the CMOs
• Author technical documents including but not limited to testing protocols, technical reports, and SOPs
• Review completed manufacturing batch documentation
• Support technology transfer and new site start-up as needed

Qualifications

• Bachelor‚Äôs degree in a scientific or technical area
• Knowledge of cGMP drug substance/drug product manufacturing and quality control

Additional Preferences

• Advanced degree preferred in a scientific or technical area
• Experience working with Radiopharmaceuticals
• Impeccable organizational skills
• Ability to work independently in a highly focused manner
• Excellent interpersonal skills and ability to collaborate with internal and external parties
• Superior written and verbal communication skills
• Excellent computer skills (e.g. Excel, Word, and PowerPoint)

Physical Demands / Travel

• The physical demands of this job are consistent with a lab and office environment.
• Must be willing and able to travel within the US 30% of the time with potential for OUS travel.