Stephanie Mitra
San Diego,CA
Summary
Experienced molecular Scientist with over 7 years of experience in the point-of-care diagnostics industry. Excellent reputation for anticipating roadblocks, understanding the product transfer process, and improving efficiency. I am an organized and dependable candidate who is successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team and company goals.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Scientist II
Sekisui Diagnostics
04.2023 - Current
- Independently designed and executed a methodical screening process for new qPCR primer/probe sets to improve sensitivity of our diagnostic assay panel.
- Regularly collaborated with Operations and Engineering teams while developing alpha and beta prototypes.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
Research Associate III
Visby Medical
09.2021 - 03.2023
- Developed an accurate and reliable method for quantifying low concentration test samples using ddPCR (digital droplet PCR) to support V&V activities.
- Worked closely with Quality and Operations to develop multiple in-process QC methods as well as the lot release method for the finished product.
- Designed, executed, and wrote test reports for multiple method validations. This involved developing timelines, resourcing and training multiple operators, and training the QC team following successful validations.
Research Associate II
Visby Medical
12.2019 - 08.2021
- Developed and validated multiple QC methods.
- Generated supporting documentation for QC methods including part specifications, bill of materials (BOM), equipment controls (IQ/OQ test protocols, new equipment forms), etc.
- Coordinated with lab management often to purchase of materials and equipment, maintain inventory, and install/maintain IUO equipment.
- Supported research lead by a senior individual contributor to develop new SNP detection methods using the Visby platform.
Research Associate I
Visby Medical
11.2017 - 11.2019
- Supported product transfer efforts by developing work instructions and improving existing ones.
- Helped my team meet regulatory requirements by developing and executing method validations and design verification testing (DVT).
- Developed an accurate and reliable method for quantifying low concentration test samples using qPCR to support V&V testing.
Lab Assistant
Visby Medical
10.2016 - 10.2017
- Optimized the visual detection method of Visby's point-of-care device by troubleshooting microfluidics and optimizing the detection reagents.
- Supported in-house manufacturing efforts.
Education
Bachelor of Science - Cell & Molecular Biology
San Francisco State University
San Francisco, CA05.2014
Skills
- BSL-2 lab experience
- Multiplex PCR optimization
- Assay development
- Lyophilization
- Troubleshooting
- Design of Experiments (DOE)
- V&V activities
- QMS systems
- Teamwork & Collaboration
- Leadership
Certification
- Google Project Management: Professional Certificate, Coursera, Sept. 2021-present (in-progress)
Timeline
Scientist II
Sekisui Diagnostics
04.2023 - Current
Research Associate III
Visby Medical
09.2021 - 03.2023
Research Associate II
Visby Medical
12.2019 - 08.2021
Research Associate I
Visby Medical
11.2017 - 11.2019
Lab Assistant
Visby Medical
10.2016 - 10.2017
Bachelor of Science - Cell & Molecular Biology
San Francisco State University
- Google Project Management: Professional Certificate, Coursera, Sept. 2021-present (in-progress)
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