The Validation Specialist will work together with the RPF managers and a cross-functional team in a fast-paced and dynamic work environment to plan, execute, and document validation experiments for the submission of a new drug application to the US FDA.

The Validation Specialist will be responsible in all aspects of the validation of manufacturing processes, including writing standard operating procedures, performing validation experiments, equipment suitability tests, and managing raw material inventory.

Key responsibilities include:

• Develop and validate standard operating procedures (SOP) that are compliant to 21 CFR 212 for the manufacturing of positron emission tomography (PET) radiopharmaceuticals
  • Under minimal supervision from RPF managers, plan and perform validation and qualification experiment
  • Perform manufacturing and quality control test of PET radiopharmaceuticals
  • Gather, process data, and write validation reports
  • Raise and complete change control reports for newly developed SOP. Perform risk assessment on validated processes and changes
• Assist in the development of New Drug Application (NDA)
  • Assist in the writing the Chemistry, Manufacturing, and Controls (CMC) section

• Independently set up, operate, and troubleshoot automated synthesis systems and quality control equipment like High-performance liquid chromatography (HPLC), Gas chromatography (GC), Radio thin layer chromatography (R-TLC), etc.
  • Develop and run system suitability test of manufacturing equipment
  • Responsible for the upkeep of daily and periodic maintenance of manufacturing equipment
  • Troubleshoot and repair manufacturing equipment
• Inventory control
  • Manage overall inventory related to the project
  • Responsible for vendor and raw material qualification
• Coordinate all activities related to NDA submission
  • Interface with external collaborators for successful process transfer

• Perform other project-relate duties and tasks as assigned.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (ucop.edu)

Please note: The compensation ranges listed online for roles not covered by a bargaining unit agreement are very wide, however a job offer will typically fall in the range of 80% - 120% of the established mid-point. An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html