Director of PET Biomarker Applications ABT Molecular
THIS JOB HAS EXPIRED Description:
The Director of PET Biomarker Applications is the ABT technical expert responsible for leading the transfer of the Biomarker Generator (BG) technical knowledge (equipment and processes) to the customer base enabling effective clinical and/or research production of PET biomarkers.
Consult with existing and potential customers by providing technical guidance about the biomarker generator (BG) hardware, specifications, QC methods, USP and EU Pharmacopeia, and cGMPs.
Assist with commissioning of the BG Chemistry Production Module (CPM) and Quality Control Module (CPM) at the factory and customer sites.
Prepare for and facilitate customer factory acceptance testing and post installation site acceptance testing of the BG.
Develop training materials and provide basic and/or advanced equipment and applications training to ABT internal and external customers. Training to include:
General overview of the BG systems
BG automated workflow
Operating procedures (start-up, cleaning, reagent installation, dose synthesis card testing, dose production)
FDG synthesis process
CPM parts and functions
Standard FDG synthesis macro
Advanced macro development (advanced / research users)
Provide consultation to customers on selection and set-up of conventional QC testing when required.
Develop and maintain ABT technical documentation (user manual, spec sheets, sales aids, training documentation, etc.).
Provide input to R&D on BG workflow, biomarker synthesis optimization, and QC methods development as necessary.
Given the senior level and expected technical "know how" of the Director of PET Biomarker Applications, this position is expected to provide technical direction and feedback as needed across all ABT functional teams (Supply Chain, Production, Research and Development, etc.)
Other duties and/or responsibilities assigned by management
Minimum of 3 years direct work experience in PET biomarker production and QC methods (specifically FDG, C-11 experience is a bonus)
Thorough knowledge of PET biomarker manufacturing workflow
Understanding of PET biomarker production cGMP's
Knowledge of US and EU PET drug quality specifications and tests
Direct experience in operation and routine maintenance of automated chemistry synthesis modules
Working knowledge of the clinical use of PET biomarkers (Direct experience working in a clinical or research PET imaging department a plus)
Other nuclear medicine and/or radiopharmaceutical industry experience a plus
5 years of senior leadership experience preferred
BS Degree or higher in science or engineering or equivalent experience
Strong knowledge and past leadership of technical services, training, and project management
Thorough knowledge of radiation safety practices and radiation monitoring equipment
Experience with cyclotron equipment and operation
Technically skilled with proven ability to troubleshoot problems, solve abstract issues, develop and implement technical policies & procedures
Ability to communicate effectively (speaking and writing) with a proven ability to provide concise technical direction to others
Ability to identify new features and processes to optimize biomarker production and testing
||Knoxville, TN |
THIS JOB HAS EXPIRED