Analytical chemist with a strong background in AAV viral vector biology. Work has emphasized assay development for vector characterization. Have management experience leading both quality assurance and quality control groups at the UNC Vector Core.
Sr. Manager Quality Control @ Develop product-specific and platform assays for AAV drug substance and drug product testing.
Manage CRO’s performing testing of drug product.
Perform quality audits of CMO’s and CRO’s.
Write, edit, and review SOPs.
Perform release testing of clinical materials.
Technical transfer of analytical methods.
Execute periodic stability testing of clinical products. From March 2015 to Present (10 months) Quality Director @ UNC Vector Core Quality Director
Responsibilities:
-Manage both the Quality Control and Quality Assurance teams
-Develop assays for the analysis of AAV gene therapy vectors.
-Participate in OOS and environmental monitoring investigations
-Write, review, and approve SOPs to comply with current good manufacturing practices.
-Maintain and improves the Vector Core quality systems for compliance with FDA standards.
-Design quality control assay qualification and validation methods.
-Perform external quality audits of suppliers of raw materials and contract services.
-Represent the Vector Core during audits by external companies.
-Exercise risk assessments of the Vector Core cGMP processes and QC testing using ICH guidelines.
-Coordinate QC stability studies for ongoing clinical trials. From July 2014 to March 2015 (9 months) Quality Control Manager @ UNC Vector Core Quality Control Manager
Responsibilities:
-Manage the Quality Control team
-Execute QC assays using current good manufacturing practices (cGMPs).
-Develop assays for the analysis of AAV gene therapy vectors.
-Perform environmental monitoring of cleanroom work spaces.
-Participate in OOS and environmental monitoring investigations
-Write, review, and approve SOPs to comply with current good manufacturing practices.
-Design quality control assay qualification and validation methods.
-Coordinate QC stability studies for ongoing clinical trials. From October 2012 to July 2014 (1 year 10 months) Post Doctoral Fellow @ Advisor: Aravind Asokan
Post-doctoral work involves probing the chemistry/virology interface using chemical modifications of amino acid side chains to alter viral transduction as well as bio-distribution. From May 2009 to November 2012 (3 years 7 months) Graduate Student @ Advisor: Nicholas V. Hud
Thesis work involved studying the underlying thermodynamic driving force behind the interaction of small drug-like molecules with DNA and RNA. From August 2003 to May 2009 (5 years 10 months) Undergraduate Research Trainee @ Advisor: Anne Andrews
Undergraduate research involved the organic synthesis of analogs of a potent neurotoxin for the generation of serotonin neuron knock-out mouse models. From September 2001 to May 2003 (1 year 9 months) Student Technician @ Research included analysis of interactions between commonly used products such as ethanol and aspirin on human platelet receptors. From June 2000 to August 2001 (1 year 3 months)
Ph.D., Chemistry @ Georgia Institute of Technology From 2003 to 2009 B.S., Chemistry @ Penn State University From 1999 to 2003 High School Diploma, Chemistry @ Franklin High School From 1996 to 1999 Eric Horowitz is skilled in: NMR spectroscopy, Circular Dichroism, UV-Vis, Fluorescence Spectroscopy, Confocal Microscopy, qPCR, ITC, DSC, SDS-PAGE, HPLC, FPLC, Affinity Chromatography, AFM, Electron Microscopy, UV/Vis
Websites:
http://voyagertherapeutics.com