Marisa Frost
Salt Lake City,UT
Summary
- Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
- Experienced manufacturing professional with over 20 years of expertise in clinical molecular diagnostics
- Molecular genetics professional with expertise in PCR techniques, DNA extraction, sequencing methods, and large rearrangement fragment analysis. Proficient in NGS microbial testing and infectious disease Metagenomics.
- Lab Manager with 10+ years of experience overseeing laboratory operations. Demonstrated expertise in Quality Control and Regulatory Affairs, leading the company to achieve QSR standards and FDA accreditation.
- Experienced clinical studies liaison managing companion diagnostics for pharmaceutical partners across 20+ countries with multiple sites per country and 12,000+ enrolled patients.
Overview
26
26
years of professional experience
Work History
Head of Regulatory Affairs and Compliance
Co-Diagnostics, Inc.
Salt Lake City, UT
11.2022 - Current
- Led efforts in utilizing research and data analysis to support strategic planning and informed decision-making.
- Successfully handled submissions and renewals for our IVD products in various countries, ensuring compliance with industry regulations.
- Supported Quality in the areas of external and internal audits, document control management, and adherence to product labeling guidelines.
- Prepared certification and approval documentation, including product dossiers, technical files, and reports for diverse jurisdictions.
- Participated in collaborative efforts for EUA and 510K submission of COVID product to FDA. Currently engaged with the Melinda and Bill Gates Foundation for submissions to CDCSO, SAHPRA, WHO, as well as other regulatory agencies.
- Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
Operations Lab Manager
IDbyDNA, Inc.
10.2019 - 05.2022
- Planned the creation of new laboratory; from lab space design, purchase of equipment and hiring of thirteen new employees
- Facilitated the development of new inventory management process that aligned purchasing, inventory usage and billing
- Coordinated the day-to-day operations of the clinical lab and the workload of the R&D team
- Guided two successful CLIA audits without deficiencies
- Managed three clinical studies with over a thousand patient samples with all testing delivered on time and on budget.
Project Coordinator
Myriad Genetics
Salt Lake City, USA
05.2017 - 10.2019
- Managed projects involving study initiation and requirements needed for both Myriad and pharmaceutical partner
- Coordinated the operations of companion diagnostic testing, using genetic cancer testing, with pharmaceutical partners from sample receipt, processing, destruction, issue resolution, data management and result reports for 12,000+ tests in a 12-month period.
Associate Product Manager
Myriad Genetics
Salt Lake City, USA
01.2017 - 05.2017
- Developed commercial product branding, creative campaigns, promotional sales materials, and training materials to support field sales team
- Collaborated with various departments including Marketing, Interactive, Conventions, and Event Planning to prepare for and execute various conferences/.
Quality Specialist II
Myriad Genetics
Salt Lake City, USA
05.2014 - 12.2016
- Quality Liaison for corporate software validation and verification testing
- Guided software team to FDA requirements for testing and validations during FDA accreditation.
Validation Project Manager-QA
Myriad Genetics
Salt Lake City, USA
12.2008 - 05.2014
- Led enterprise change management kaizen and developed quality improvement projects
- Developed, reviewed, and approved verification and validation protocols and resulting data to identify product and process related issues.
Laboratory Supervisor-Fragment Analysis Group
Myriad Genetics
Salt Lake City, USA
04.2006 - 12.2008
- Coordinated transition of clinical large rearrangement testing processes from research to clinical operations
- Led the laboratory in project for integration of parallel testing with existing clinical testing.
Supervisor and lead technician
Myriad Genetics
Salt Lake City, USA
11.1998 - 04.2006
- Participated in design, documentation, testing, and implementation of clinical operation projects
- Assisted in DNA identification efforts for the world trade center victims of 9/11.
Education
Master of Business Administration -
Brigham Young University
Provo, UT08.2018
Master in Laboratory Medicine and Biomedical Sciences -
University of Utah
Salt Lake City, UT12.2005
Bachelor of Science – Molecular Biology with Minor in Chemistry -
Brigham Young University
Provo, UT08.1995
Skills
- Project Planning, Quality Assurance, Decision-Making, Customer Relations, Data Management, Written Communication
- Microsoft Office, Smartsheet, Excel, Access, and Visio
- Monday, Basic SQL,Tableau (intermediate skills), Azure (intermediate skills)
- MasterControl, MediaLab, Green Light Guru
Awards
- Excellence in Management, Myriad’s HR, 2007
- Certificate of Appreciation, Office of Chief Medical Examiner of NYC, 2003, For work on World Trade Center victims’ identification project
Languages
Portuguese
Native/ Bilingual
Spanish
Professional
English
Native/ Bilingual
References
References available upon request.
Timeline
Head of Regulatory Affairs and Compliance
Co-Diagnostics, Inc.
11.2022 - Current
Operations Lab Manager
IDbyDNA, Inc.
10.2019 - 05.2022
Project Coordinator
Myriad Genetics
05.2017 - 10.2019
Associate Product Manager
Myriad Genetics
01.2017 - 05.2017
Quality Specialist II
Myriad Genetics
05.2014 - 12.2016
Validation Project Manager-QA
Myriad Genetics
12.2008 - 05.2014
Laboratory Supervisor-Fragment Analysis Group
Myriad Genetics
04.2006 - 12.2008
Supervisor and lead technician
Myriad Genetics
11.1998 - 04.2006
Master of Business Administration -
Brigham Young University
Master in Laboratory Medicine and Biomedical Sciences -
University of Utah
Bachelor of Science – Molecular Biology with Minor in Chemistry -
Brigham Young University
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