MAYA GORGAS
San Francisco,CA
Summary
Advanced Regulatory Analyst & Policy Program Manager with expertise in cross-functional strategic communication and interpretation of federal agency regulations. Values human connection on a professional and personal level and works hard to establish influential collaborative relationships internally and externally. An avid bassoonist, as well as an active member of Genentech's LGBTQIA+ DE&I leadership team.
Overview
5
5
years of professional experience
Work History
Regulatory Analyst
Genentech
09.2022 - Current
- Orchestrate end-to-end FDA guidance commenting process. Identify policy influencing opportunities, distill guidance content for internal audience of 1500+, analyze comments and draft comment letters
- Implement multi-platform communication strategy among cross-functional stakeholders
- Execute regulatory related queries across regulatory agency websites, reviews (EPARS, SBAs), and use available databases to identify regulatory approval, labeling and clinical trial design precedence as required by research queries
- Prepare and submit regulatory file applications and supporting documentation
Laboratory Instructor
Georgetown University Washington D.C, Science Academy
07.2022
- Led laboratory sessions, involving PCR, CRISPR, DNA/RNA extractions, for 25 high school students
- Improved student’s analytical skills, provided guidance and feedback to students to encourage the development of original responses to biotechnology & biochemistry related questions
- Exercised strong communication skills to facilitate engaged and thoughtful student discussion
Breast Cancer Research Intern
Georgetown University Washington D.C
01.2022 - 05.2022
- Experienced in many lab techniques and maintaining healthy cell cultures to investigate the role of reactive oxygen species (ROS) in drug efficacy in breast cancer cells
- Employed strong organizational skills, notetaking abilities, and attention to detail to carry out successful experimentation procedures
- Proven track record of solid interpersonal skills to effectively communicate with other staff and lab personnel, including editing of SOP’s and troubleshooting with one another to help facilitate better results for future trials
Field Research Assistant
UC Santa Barbara Santa Barbara, Marine Science Institute
06.2020 - 08.2021
- Assisted in the field research of a project that focused on exploring the potential use of environmental DNA (eDNA) to map distributions of coastal species
- Collected over 500 water samples using highly sterile techniques for data processing and analyzation
- Organized & prepared scientific supplies, and managed logistical details for each research trip
Coral Reef Focused - Research Technician
National Science Foundation
06.2018 - 10.2019
- Implemented and maintained over 50 different experiments and research projects focusing on coral reef ecosystem dynamics, and provided my expertise on biological surveys and project plans
- Deployed, retrieved, and programmed oceanographic instruments for climate change analysis pertaining to coral reefs
- Collected and analyzed algal, coral, and invertebrate samples at 18 sites; Logged up to 4 dives per day
- High level of comfortability working with people with different perspectives in a fast-paced and dynamic environment
Education
Master of Science - Biochemistry
Georgetown University Biomedical
Washington, DC05.2022
Bachelor of Science - Biology
University of California, Santa Barbara
Santa Barbara, CA03.2020
Skills
- Soft: MS Office, Leadership, Project Management, Regulatory Intelligence, Policy Analysis, Organization
- Hard: Basic Knowledge of R, Agisoft 3-D Modeling, Flow Cytometry Analysis, Pymol, Chimera
Additional Information
- Part of Genentech's gPRIDE leadership team
- First bassoon in San Francisco's 'Civic Symphony'
- Backpacker, surfer, snowboarder, environmentalist
Timeline
Regulatory Analyst
Genentech
09.2022 - Current
Laboratory Instructor
Georgetown University Washington D.C, Science Academy
07.2022
Breast Cancer Research Intern
Georgetown University Washington D.C
01.2022 - 05.2022
Field Research Assistant
UC Santa Barbara Santa Barbara, Marine Science Institute
06.2020 - 08.2021
Coral Reef Focused - Research Technician
National Science Foundation
06.2018 - 10.2019
Master of Science - Biochemistry
Georgetown University Biomedical
Bachelor of Science - Biology
University of California, Santa Barbara
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