Cody Beaumont
Spanish Fork,Utah
Summary
Experienced quality professional with expertise in all aspects of quality assurance and quality control. I have extensive experience in clinical and commercial manufacturing drug substance, drug product, and API as well as coordinating CMO and CDMO activities related to manufacturing and quality processes. A large part of my career has been dedicated to developing high functioning and efficient teams focused on GMP/GLP QA/QC, and research. I have a passion for developing and organizing efficient fit for purpose processes.
Overview
12
12
years of professional experience
Work History
Adjunct Professor
Roseman University
MS in Research Program
10.2021 - Current
- Teach the topic of Biomedical Research and Regulation to Master’s students
- Develop and present education topics of clinical research, history and current practice, phase appropriate research, research type, and quality regulations
- Strategically plan and create testing material for student assessment
- Support exam preparation activities
- Review student test results and reassess for topic understanding
- Support post exam review and student questions
- Support Roseman initiatives and student candidacy for program acceptance
- Mentor 2nd year program student for internship
- Plan and prepare a list of potential research projects for potential intern when needed
- Support planning and evaluate the appropriateness of research project selection
- Collaborate with Roseman Research Dean on internship project completion, pass/fail status.
Sr. Director, Quality
Denali Therapeutics
Utah Clinical Manufacturing, UT
12.2021 - 12.2023
- Site quality head responsible for Quality Assurance and Quality Control activities for clinical and commercial manufacturing of large molecule biologic DS/DP.
- Strategically plan and implement a fit for purpose QMS and other quality processes including, environmental monitoring, contamination control strategy, raw material and stability programs.
- Responsible for external auditing and vendor qualification program for Salt Lake City facility including material suppliers and contract laboratory services.
- Support manufacturing operations for equipment commissioning and qualification.
- Partner with process development and MSAT for technical transfer of processes.
- Support commissioning and qualification activities for facility and utilities.
- Responsible for development, implementation, and oversight of analytical method validation program.
- Collaborate with IT for CSV of all systems including BMS, data historian, LIMS, electronic QMS and others.
- Collaboration with Manufacturing operations to assess deviations, determine root cause, and execute preventive and corrective actions
- Build and lead a team responsible for QA/QC, Technical support, and technical transfer of bulk drug substance and analytical methods.
- Oversee Analytical and Microbiology QC laboratories for release testing for product disposition.
- Support SSF Quality staff for CMO/CDMO document review, quality agreements, batch release, GCP activities, internal and external audits and others.
- Conducted evaluations of facility operations, team performance and business policies to standardize activities.
- Managed multiple projects simultaneously while ensuring deadlines were met.
- Organized team activities to build camaraderie and foster pleasant workplace culture.
- Analyzed problematic situations and occurrences to provide solutions and facilitate company survival and growth.
- Optimized expenditures through company-wide cost reduction initiatives.
- Evaluated training needs of employees based on job roles and responsibilities.
- Implemented and prepared comprehensive business plans to expand business.
- Researched and negotiated pricing to reduce cost of equipment and supplies.
Sr. Director, Quality Control
LFB USA
10.2020 - 12.2021
- Oversee transfer of quality processes for CMO and CDMO related to fill/finish process for biologics
- Responsible for all internal and external quality testing and assay transfer
- Oversee and mentor QC group leaders and staff
- Support and direct QC organization during release, stability, and in-process testing
- Support regulatory inspections and audits of QC organization
- Oversee equipment maintenance, calibration, and general laboratory maintenance
- Oversee GMP material control program
- Primary oversight, planning, and implementation of analytical development assays
- Oversee Assay Control, Reference Standards, Critical Reagents, and OOS programs
- Provide guidance and assure conformance to company and department processes on investigation of Out of Specification (OOS) results
- Member of the quality management team.
Sr. Director, Research & Quality Control
dōTERRA Int.
01.2019 - 10.2020
- Direct authority in evaluation and hiring of all Research staff
- Oversee CDMO research activities related to manufacturing of drug product for clinical studies
- Principle investigator and strategist for biologics development and assay development
- Primary oversight, planning, and implementation of analytical development assays
- Develop and oversee the operation and goals of the Research and Quality departments
- Oversee current research initiatives
- Direct involvement and authorship in clinical research study protocols, plans, IRB submissions, technical and manuscript writing
- Oversee and develop new and existing collaborative research partners and research organization affiliations
- Oversee product development through formulation
- Developing processes and staff for increased visibility and collaboration with outside departments
- Develop doTERRA external market R&D groups
- Routine internal QC and QA auditing of developed processes
- Collaboration with Quality Assurance, Regulatory Affairs, Marketing, and Executive team
- Continuation of all duties listed below as Director, Quality Control and Analytical Services.
Director, Quality Control & Analytical Services
dōTERRA Int.
04.2015 - 12.2018
- Planned and oversaw the laboratory build and implementation of all QC and analytical functions
- Primary oversight, planning, and implementation of analytical development assays
- Direct the daily operations of internal and external analytical functions
- Implementation of LIMS and all functionality
- Built high-quality process around internal and external quality auditing
- Built a robust stability program
- Communicate regularly as a member of leadership committee
- Primary quality representative in regulatory audits
- Collaborate with oversite for development of quality management system
- Provide guidance and assure conformance to company and department processes on investigation of Out of Specification (OOS) results
- Built, implemented, and oversee all laboratory personnel training
- Developed contract laboratory evaluation, qualifications, and auditing
- Direct and implement all internal laboratory methodology
- Build research partnerships and collaborations
- Responsible for organization and deliverables of research projects
- Solely responsible for Quality Control and Analytical Services annual budget.
Director of Analytical Sciences
Neways Inc.
01.2014 - 04.2015
- Lead and direct analytical, physical, and microbiology labs
- Oversee stability program
- Oversee all analytical functions
- Direct training path and plans for all Analytical and QC staff members
- Provide guidance and assure conformance to company and department processes on investigation of Out of Specification (OOS) results
- Developed strong working relationships with R&D, Regulatory, Quality Assurance, Marketing, and Operations departments
- Deeply involved in regulatory testing and evaluation
- Work closely with quality department
- Support quality representative in regulatory audits
- Troubleshoot instrumentation
- Oversee LIMS and all functionality
- Responsible for all final disposition of results and release of Certificate of Analysis
- Responsible for Analytical Sciences department goals and budgets.
Laboratory Director (Consultant)
Advanced Laboratories
09.2011 - 10.2013
- Consultant activities related to implementation of chemistry services
- Oversee the planning and development of HPLC, GC, and MS methodology
- Responsible for development of Quality Manual, QMS, and training program
- Responsible for preparation of FTE staff for onsite customer and regulatory audits
- Responsible for all lab functions and data review
- Coordinate, direct, and oversee all personnel involved in testing labs
- Supported the evaluation and hiring of a method validation team and QC chemistry group
- Directed the development of alternative analytical procedures
- Authored, implemented, and trained laboratory staff on procedures
- Implemented internal auditing program
- Work closely with outside regulatory agencies
- Compile, analyze, verify, and report all analytical test data.
Education
Post-Doc, Investigational Drug Studies -
University of Utah Hospitals and Clinics
07.2004
Doctorate of Medicinal Chemistry -
University of Michigan
Ann Arbor05-2003
BS Chemistry -
Southern Utah University
Cedar City05-1999
Skills
- Large molecule biologics manufacturing
- 21 CFR Part 11, 58, 111, 210/211, 820
- Teaching and mentorship
- CSV/CSA
- Leadership and staff development
- Laboratory management
- GMP, GCP, GDP, GLP
- Vendor Qualification
- Analytical and Process Development
- QMS (Change Management, CAPA, Investigations, Document Management
Affiliations
- American Chemical Society (ACS)
- ACS Division of Medicinal Chemistry
- ACS Division of Organic Chemistry
- Association of Official Analytical Chemists (AOAC)
- American Society of Mass Spec (ASMS)
- American Oil Chemists’ Society (AOCS)
- International Society of Pharmaceutical Engineers (ISPE)
Publications
- Yasuyo Urasaki, Cody Beaumont, Michelle Workman, Jeffery N. Talbot, David K. Hill, Thuc T. Le
- Fast-Acting and Receptor-Mediated Regulation of Neuronal Signaling Pathways by Copaiba Essential Oil. Int J Mol Sci. 2020 Mar 25;21(7):2259. doi: 10.3390/ijms21072259.
- Yasuyo Urasaki, Cody Beaumont, Jeffery N. Talbot, David K. Hill, Thuc T. Le
- Akt3 Regulates Tissue-Specific Response to Copaiba Essential Oil. Int J Mol Sci. 2020 Apr 19;21(8):2851. doi: 10.3390/ijms21082851
- Potency Assessment of CBD Oils by Their Effects on Cell Signaling Pathways. Nutrients. 2020 Jan 30;12(2):357. doi: 10.3390/nu12020357
- Bahr T, Rodriuez D, Beaumont C, Allred K. The Effects of Various Essential Oils on Epilepsy and Acute Seizure: A Systematic Review. Evidence-Based Complementary and Alternative Medicine 2019, 6829428
- Han X, Beaumont C, Rodriguez D, Bahr T. Black Pepper (piper nigrum) Essential Oil Demonstrates Tissue Remodeling and Metabolism Modulating Potential in Human Cells. Phytotherapy Research. 2018; 1-5. https://doi.org/10.1002.ptr.6110
- Han, X., Beaumont, C., Stevens, N., 2017a. Chemical composition analysis and in vitro biological activities of ten essential oils in human skin cells. BioChem. Open 5, 1-7.
Timeline
Sr. Director, Quality
Denali Therapeutics
12.2021 - 12.2023
Adjunct Professor
Roseman University
10.2021 - Current
Sr. Director, Quality Control
LFB USA
10.2020 - 12.2021
Sr. Director, Research & Quality Control
dōTERRA Int.
01.2019 - 10.2020
Director, Quality Control & Analytical Services
dōTERRA Int.
04.2015 - 12.2018
Director of Analytical Sciences
Neways Inc.
01.2014 - 04.2015
Laboratory Director (Consultant)
Advanced Laboratories
09.2011 - 10.2013
Post-Doc, Investigational Drug Studies -
University of Utah Hospitals and Clinics
Doctorate of Medicinal Chemistry -
University of Michigan
BS Chemistry -
Southern Utah University