Experience

Viewpoint Molecular Targeting, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Director of Radiopharmaceutical Production

  • Apr 2021 - Present

  Leading company efforts to bring new radiopharmaceuticals into clinical production. Lead the expansion of production sites for the clinical trials of multiple radiopharmaceutical imaging and therapy agents. Leading company efforts to bring new radiopharmaceuticals into clinical production. Lead the expansion of production sites for the clinical trials of multiple radiopharmaceutical imaging and therapy agents.



Optimal Tracers

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Site Manager/Sr.Radiochemist

  • Nov 2015 - Apr 2021

  Site Manager/Sr. PET Radiochemist responsible for managing the site and support technicians to ensure operational as well as patient standards are consistently maintained. Ensures production of PET radiopharmaceuticals to clinical and pre-clinical standards as part of CMO activities. Services the development and optimization of generic and novel PET Radiopharmaceutical in a cGMP environment. Partake in regulatory agency filings and audit responses. Site Manager/Sr. PET Radiochemist responsible for managing the site and support technicians to ensure operational as well as patient standards are consistently maintained. Ensures production of PET radiopharmaceuticals to clinical and pre-clinical standards as part of CMO activities. Services the development and optimization of generic and novel PET Radiopharmaceutical in a cGMP environment. Partake in regulatory agency filings and audit responses.



Zevacor

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Sr. Radiochemist

  • Oct 2014 - Oct 2015

  Led and participated on cross-functional teams focused on the development of Molecular imaging agents, Radioimmunotherapy (RIT) drugs and Sterile Injectables. Contributed to product authorization inspections and regulatory submissions.

• CMC Radiochemist/Field Service Engineer

  • Apr 2011 - Oct 2014

  • Lead, organize and participate in the technological transfer of production processes (synthesis and analytical) to production sites, such as the approved radiopharmaceutical Neuraceq used in PET imaging of beta-amyloid protein in Alzheimer’s and Parkinson’s disease.• Lead the development, implementation and validation of new radiopharmaceuticals as part of CMO/CRO activities. • Participates in the qualification/validation campaign for new radiopharmaceuticals implementation according to GMP standards.• Contribute to R&D program on new PET tracers and industrialization of new synthesis processes.• Install and qualify new equipment on sites.• Perform all quality tests.• Provide technical support across all manufacturing sites.• Follow SOP guidelines for QC release testing of radiopharmaceutical products, raw materials, finished and semi-finished products, environment and facilities. • Perform method development, review procedures, propose modifications, improvements and updates.• Participate in regulatory agency audits and submissions for approvals.



PETNET Pharmaceuticals, a Siemens Company

• QA/QC

  • Jul 2009 - Mar 2011

  • Experience in radiopharmaceutical production using automated/non-automated synthesis modules.• Performs quality control processes of radiopharmaceuticals such as F-18 and N-13.• Compiles and records test results and observations on batch records and other standardized forms.• Participates in making adjustments and maintenance to manufacturing and testing equipments.• Participates in investigations into radiopharmaceutical process and product deviations.• Participates in problem solving/troubleshooting to enhance manufacturing and testing processes. • Experience with safe handling of radioactive materials.



Millennium Chemicals

• Analyst/Microbiologist

  • Aug 2002 - Dec 2009

  • Conducts chemical analysis on in-process samples, raw materials, and finished products.• Analyze testing results and data and reports on discrepancies related to product quality.• Assists during root cause investigation and in the development of corrective actions for discrepancies.• Operate and maintain sophisticated instruments as well as recommend updated technologies and instruments.• Interface with R&D and Manufacturing to develop and enhance new/existing products. • Creates and revise SOPs for equipments and test methods within laboratory facilities.• Contribute to operation and continuous quality improvement efforts site wide. • Participate in customer quality counsels and communication meetings to address customer complaints.



Towson University

• United States
• Higher Education
• 700 & Above Employee

• Research Associate

  • Aug 2007 - Dec 2007

  • Supported efforts to characterize evolutionary relationship of microbes through analytical research methods. • Prepared media/agar and reagents and validated growth media to assure their support of microbial growth. • Employed data acquisition methods, interpreted and summarized results, and authored and presented reports. • Supported efforts to characterize evolutionary relationship of microbes through analytical research methods. • Prepared media/agar and reagents and validated growth media to assure their support of microbial growth. • Employed data acquisition methods, interpreted and summarized results, and authored and presented reports.



Loyola College in Maryland

• Research Assistant

  • Sep 2001 - May 2002

  • Conducted experiments utilizing growth and incubation chambers, applied Microbial genetic techniques and maintained aseptic conditions in defined areas to prevent microbial and cross contamination. • Authored research papers, maintained data and research documents and presented findings at 16th National Conference on Undergraduate Research and BETA BETA BETA Student Research symposium. • Conducted experiments utilizing growth and incubation chambers, applied Microbial genetic techniques and maintained aseptic conditions in defined areas to prevent microbial and cross contamination. • Authored research papers, maintained data and research documents and presented findings at 16th National Conference on Undergraduate Research and BETA BETA BETA Student Research symposium.