Nick Baca Email & Phone Number

• Conducted strategic evaluation of prospective clinical dosimetry projects for feasibility in terms of CDE technical dosimetry expertise, dosimetry project capacity. • Composed project budgets, proposals, and scopes, in collaboration with CDE President.• Management of clinical dosimetry project startup, including direct oversight of data transfer agreements and specification and operations, site qualification processes, and development of project related technical documents and procedures. • Supervised operations of CDE Quality Management, Information Technology, and Clinical Data Management.• Performed patient dosimetry analyses, including Planar, SPECT, Hybrid, and PET methodologies per MIRD guidelines, including image quantification, biokinetic modeling, and radiation transport modeling under supervision of CDE senior dosimetrist.• Designed and implemented CDE Quality Management System for compliance with ICH E6 (R2) GCP, GDPR, 21 CFR 11, and other relevant industry standards.• Management of aspects of quality systems and regulatory compliance, including document change controls, risk assessments, employee training, computerized system change control and validations, vendor management and oversight, CAPAs, and internal QMS audits.• Facilitated Sponsor and CRO routine audits of CDE’s QMS during vendor qualification and due diligence onboarding processes.• Provided technical guidance on radionuclide labeling mechanisms and coordination stability of radiopharmaceutical therapeutics and diagnostics.

Knoxville, Tennessee, United States

• Developed internal IOQ/validation documentation for 21 CFR 11 compliant enterprise software suite used for radiopharmaceutical analytical quality control testing and managed network-wide software process validation, qualification, and deployment.• Designed improvements for sponsor radiopharmaceutical production processes, including chemistry process improvements with the aim of increased radiochemical yields, and analytical method optimization to improve testing reliability.• Revised technology transfer and process validation procedures. • Reviewed completed documentation used for biomarker production implementation, and performed on-site process qualifications.

Knoxville, Tennessee Area

• Provided remote and on-site technical support/training to field personnel for radiopharmaceutical manufacturing processes, including chemistry modules, process chemistry, production processes, quality control, equipment, and associated software applications.• Developed and maintained technical documentation related to chemistry module performance improvements, quality control testing, as well as maintenance and troubleshooting of analytical equipment used for product testing.• SME on radiopharmaceutical production process and related quality control testing. Collaboration with process owners and PETNET network to ensure contract manufacturing production batch success and maximize dose fulfillment.

Phoenix, Arizona Area

• Managed the manufacturing processes and quality control monitoring of radiopharmaceutical in accordance with 21 CFR 211 and 212.• Conducted investigations to determine root causes of QC non-conformities and implemented corrective actions accordingly. • Performed preventative maintenance, troubleshooting and qualifications on equipment associated with radiopharmaceutical production, including: Bruker 450-GC, Agilent 3800-GC, Agilent 1200 HPLC, Siemens Explora GN/LC.• Maintained site documentation for all records pertaining to radiopharmaceutical manufacturing and quality monitoring, including: production batch records, maintenance logs, qualification records, and sterility trending.

Master Of Science - Ms, Medical Physics

Masters Of Science, Chemistry

Thesis: Weldability and corrosion resistance of OF Cu47Ti34Zr11Ni8 metallic glass

Bachelor Of Science, Chemistry