Experience

Cytovance Biologics

• United States
• Biotechnology Research
• 100 - 200 Employee

• Manufacturing Specialist

  • 2017 - Present

  Support Upstream Manufacturing Investigation Reporting and Process Support Upstream Manufacturing Investigation Reporting and Process



CPI Global CRO

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Clinical Quality Assurance

  • May 2014 - Apr 2017

  Creation, revision and management of Quality Management System and document management for small CRO sponsored largely by Pfizer on an international scale; Established Audit Program conducting remote/external and internal audits. Submission of Audit Reports and supporting documentation. Resolution of compliance issues. Strong knowledge of ICH E6, GCP’s, FDA Clinical guidelines and other international regulations Creation, revision and management of Quality Management System and document management for small CRO sponsored largely by Pfizer on an international scale; Established Audit Program conducting remote/external and internal audits. Submission of Audit Reports and supporting documentation. Resolution of compliance issues. Strong knowledge of ICH E6, GCP’s, FDA Clinical guidelines and other international regulations



MedImmune

• United States
• Biotechnology Research
• 700 & Above Employee

• Upstream Manufacturing Specialist

  • Dec 2013 - May 2014

  Supporting Upstream Manufacturing in both a Commercial and Clinical environment with non-conformance investigations within the Trackwise Data Management Systems. Review and auditing of documentation associated with large upscale manufacturing processes and CMO obligations associated with Commercial and Clinical procedures. Lead Investigator creating root cause analysis reports and corrective and preventive actions associated with non-conformances. Supporting Upstream Manufacturing in both a Commercial and Clinical environment with non-conformance investigations within the Trackwise Data Management Systems. Review and auditing of documentation associated with large upscale manufacturing processes and CMO obligations associated with Commercial and Clinical procedures. Lead Investigator creating root cause analysis reports and corrective and preventive actions associated with non-conformances.



Sanofi Pasteur

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Control Document Manager

  • May 2008 - Nov 2012

  Creation, Revision, and Updating of Quality Control Documents within cGMP, ISO14001, FDA, and International and internal guidelines; Collaboration between the various departments of QC, QA, and Production for the completion of Change Controls, Action Items, and Deviations. Auditing of departmental procedures for compliance and regulatory standards with the FDA and Global Market; Participation in FDA and International audits as a scribe; Training Coordinator and Trainer for department specific processes. Management of Laboratory Record Book preparation, processing, and archival. LabWare LIMS and Trackwise Quality Systems knowledgeable



AppTec, Inc

• United States
• Pharmaceutical Manufacturing

• Senior Manufacturing Associate

  • Nov 2007 - May 2008

  Small scale pilot studies for process development and verification of client processes for transfer to Manufacturing cGMP Production of Master Cell banks in Cell Banking Suites; SOP and Batch Record writing and revision; Scheduling of upcoming projects, communication, and reporting to Client; Cell Culture work in Sterile Suites; Team Leader. Small scale pilot studies for process development and verification of client processes for transfer to Manufacturing cGMP Production of Master Cell banks in Cell Banking Suites; SOP and Batch Record writing and revision; Scheduling of upcoming projects, communication, and reporting to Client; Cell Culture work in Sterile Suites; Team Leader.



NeoTropix Inc

• United States
• Software Development
• 1 - 100 Employee

• Scientist

  • Apr 2006 - Jun 2007

  Individually established the Upstream Process for novel virus with oncolytic properties in Novel PER.C6 cell line and HEK293 cells; transfered process from a serum based, adherent culture to a serum-free suspension platform in Wave Bioreactor (1L, 5L, 10L); optimization of media, resolution of technical and quality issues, determination, validation, and qualification of scale-up process Potency assay-TCID50; stability studies, FACS analysis, qPCR for residual host cell DNA, Western Blot, SDS-PAGE, purification by CsCl, preparation of process for tech transfer to CMO; All documentation creation for IND and tech transfer following established FDA guidelines for product release, including batch record and SOP writing. Collaboration and troubleshooting among all departments; extensive literature research; strong ability to work independently.



Fujirebio Diagnostics Inc

• Manufacturing Associate

  • Jan 2003 - Jan 2006

  Extensive MaB Hybridoma cell culture in Celligen Bioreactor(5L), Unisyn-Perfusion Bioreactors, and spinner flasks up to 15L; point samples and IgG sample testing; protocol modification, troubleshooting and investigative work, ELISA protocol creation and implementation, excellent collaborative and research skills. Validation and Qualification work in cGMP/ISO9001 environment. Extensive MaB Hybridoma cell culture in Celligen Bioreactor(5L), Unisyn-Perfusion Bioreactors, and spinner flasks up to 15L; point samples and IgG sample testing; protocol modification, troubleshooting and investigative work, ELISA protocol creation and implementation, excellent collaborative and research skills. Validation and Qualification work in cGMP/ISO9001 environment.



Merck & Co

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Process Engineer

  • Jan 2003 - Aug 2004

  For HPV vaccine involving collaboration with Manufacturing and Research and Development. Validation work for upscale of vaccine including Western Blot and PCR; establishment of validation For HPV vaccine involving collaboration with Manufacturing and Research and Development. Validation work for upscale of vaccine including Western Blot and PCR; establishment of validation



Charles River Laboratories

• United States
• Biotechnology Research
• 700 & Above Employee

• Cell Culture Technician

  • Jun 2002 - Aug 2002

  Cell culture work with a vast array of cell lines, work included cell banking, aseptic technique, sterile room preparation, following guidelines in GLP, SOP, and GMP environment. Cell culture work with a vast array of cell lines, work included cell banking, aseptic technique, sterile room preparation, following guidelines in GLP, SOP, and GMP environment.



University of Pennsylvania

• United States
• Higher Education
• 700 & Above Employee

• Research Specialist

  • Jan 2001 - Jan 2002

  Extensive tissue culture work with neuronal cell lines and hybridoma’s including transfections, cloning, application of inducible system and adenovirus. Alzheimer’s research exploring the formation of fibrils. Project leader for Transgenic mouse work including breeding, In-vivo and In Vitro methodologies, Rodent surgery and brain extraction for western analysis, genotyping by southern blot, PCR, and radiolabeling of antibodies. Immunohistochemistry, General histochemistry and biochemistry including ELISA.


King’s College
• United States
• Higher Education
• 700 & Above Employee
• Cognitive Neuroscience Lab Manager

  • Jan 1999 - Jan 2001