Open To Work
Matthew E. Hinz
Clear Spring,MD
Work Preference
Summary
Expert in managing clinical sample testing and regulatory compliance, with a focus on optimizing vendor relations to meet project demands. Skilled in developing technical solutions and orchestrating project alignment across subcontractors to ensure successful outcomes.
Overview
1
1
Certification
32
32
years of professional experience
Work History
Clinical Sample Testing Project Manager
DynPort Vaccine Company, LLC, a GDIT Company
Frederick, MD
01.2013 - Current
- Directed complete clinical sample testing management for NIAID programs, spanning various studies and phases.
- Led cross-functional teams to ensure project alignment and timely execution.
- Coordinated stakeholder communications to facilitate transparency and engagement.
- Orchestrated management of complex testing protocols, with multiple analytes and clinical matrices.
- Developed technical solutions, analyzing client RTOPs and crafting SOWs for partner labs.
- Qualified and audited suitable contract research laboratories to meet stringent contractual and GCP and GLP requirements.
- Established testing requirement and endpoints, authored development reports, and audited validation protocols and study data for compliance.
Stability and Logistics Manager,
DynPort Vaccine Company, LLC
Frederick, Maryland
01.2010 - Current
- Managed DVC stability programs for Department of Defense and two GMP biological vaccine products, by collaborating with cross-functional team to develop, tech transfer, and validated assays to assess key quality attributes and develop stability testing strategy.
- Authored statements of work for bid proposals based on stability plans and selected test facilities.
- Coordinated technical execution of DVC plans, scheduled sample transfers, reviewed test results for compliance, and resolved OOS and technical issues.
- Led reference materials program by establishing technical specifications and approving vendor data packages.
- Wrote and reviewed sections of eCTD sections and contributed to official FDA regulatory submission.
- Oversaw testing, shipping, and analysis of drug substances, products, cell banks, and reference materials.
Manager, Environmental Compliance and Stockpile
DynPort Vaccine Company, LLC
Frederick, Maryland
01.2001 - 01.2010
- Managed potency testing for seven biodefense vaccines, including live attenuated and inactivated products.
- Oversaw DVC repository program for DoD legacy biodefense products, ensuring FDA compliance.
- Collaborated with consultants to implement quality and safety testing for legacy vaccine products.
- Defined shipping requirements and validated configurations for clinical and nonclinical sample testing.
- Led F. tularensis LVS vaccine program, validating ELISA assays for antibody responses across multiple species.
- Directed scientific oversight of in vitro and in vivo stability testing for legacy biodefense products.
Research Chemist - Civilian
U.S. Army (United States Army Medical Research of Infectious Diseases (USAMRIID)
Frederick, MD
02.1997 - 01.2001
- Study Director/ Principal Investigator for several GLP studies, testing the in vivo and in vitro potency of stockpiled viral and bacterial biodefense vaccines.
- Developed and validated mouse potency assay for recombinant botulinum vaccine, currently utilized in ongoing research.
- Established GLP compliant research laboratory, enabling continued use of five vaccines in biodefense stockpile.
Biological Research Specialist (01-H), Specialist (E-4)
U.S. Army
01.1994 - 01.1997
- Cloned and purified bacterial DNA to assess toxin binding epitopes, enhancing understanding of venom interactions.
- Cultured and purified recombinant snake venom proteins in E. Coli using High performance liquid chromatography (HPLC).
- Trained and supervised four enlisted personnel in laboratory protocols and BSL-2 safety procedures, ensuring compliance and operational readiness.
Education
MS - Environmental Biology
Hood College
Frederick, MD01-2000
BA - Physics, Chemistry and Mathematics
Concordia College
Moorhead, MN01-1993
Skills
- Clinical sample testing
- Regulatory compliance
- Analyte development
- Quality assurance
- Data analysis
- Risk management
- Sample handling
- Project management
- Logistics management
- Vendor qualification
- Cross-functional collaboration
- Technical writing
Certification
Project Management Professional, Project Management Institute, 01/01/05
Publications
Rao V, Hinz ME, Roberts BA, Fine DL, Environmental hazard assessment of Venezuelan equine encephalitis virus vaccine candidate strain V3526, Vaccine, 2004, 22, 2667-2673
Leadership Experience
- Treasurer, Hagerstown Choral Arts, Hagerstown, MD, 01/01/25 to Present
- Finance Committee Chair, Christ Reformed Church, Hagerstown, MD, 01/01/20 to 01/01/22
Timeline
Clinical Sample Testing Project Manager
DynPort Vaccine Company, LLC, a GDIT Company
01.2013 - Current
Stability and Logistics Manager,
DynPort Vaccine Company, LLC
01.2010 - Current
Manager, Environmental Compliance and Stockpile
DynPort Vaccine Company, LLC
01.2001 - 01.2010
Research Chemist - Civilian
U.S. Army (United States Army Medical Research of Infectious Diseases (USAMRIID)
02.1997 - 01.2001
Biological Research Specialist (01-H), Specialist (E-4)
U.S. Army
01.1994 - 01.1997
MS - Environmental Biology
Hood College
BA - Physics, Chemistry and Mathematics
Concordia College