Michaela Solís
Michaela graduated from Florida International University in 2019 having majored in Biology with a minor in Chemistry with Honors. She is currently working at Genentech in a dual role as both a Process Validation Coordinator and Technical Development Scientist in San Francisco, CA. She began her Msc in Bioinformatics in 2021 at Northeastern University and aspires to work in the field of drug development and discovery.
Genentech /Roche
Process Validation Coordinator/ Technical Development Scientist
2023 - Present • San Francisco, California, USA
Dual/ hybrid role: in-laboratory + project management; Key responsibilities included coordinating Process Characterization and Validation (PC/PV) study samples, managing their preparation, submission, and testing. Project management tasks involved monitoring study progress, collaborating with stakeholders to address challenges, and ensuring compliance with cGMP and Quality Standards.
Contributed to the Process Validation team by working independently and collaboratively across internal departments, vendors, and global partners within the Roche network. Duties included writing and reviewing PC/PV protocols and reports, presenting analytics at various meetings, and authoring work instructions and test procedures to support assay best practices.
In the Technical Development Scientist role, supported routine and non-routine analysis of samples from Pharma Technical Development and Research, including PC/PV studies and in-process tests of GMP runs, utilizing assays such as ELISA, LAL, and HPLC.
Led efforts to digitize the PV workflow by collaborating with internal developers to create new digital processes and structure data within a database for stakeholder access.
Genentech
Research Associate II
2022-2023 • San Francisco, California, USA
Laboratory based role; supported R&D and Process Validation studies by running assays to analyze data and report results in multiple assay methodologies, such as LAL, ELISA & HPLC. Performed assays both through manual preparation and using automated liquid handling systems & robotic systems.
Collaborated with the Process Validation team to develop an SQL-based dashboard within the Benching platform to better organize molecule sample type information for dilution schemes and sample qualifications for assay preparations.
Specialized in troubleshooting and remotely resolving issues related to hematology analyzers, including DxH 600, DxH 690T, DxH 800, DxH 900, and SlideMaker Stainer I & II. Responsibilities included collecting, analyzing, and reviewing data in compliance with FDA and HIPAA regulations.
Operated efficiently in a fast-paced environment to address and resolve instrument hardware and software issues, quality control and patient result discrepancies, and LIS connection problems. Additional duties involved responding to customer inquiries and providing guidance and training on laboratory procedures.
Maintained effective communication with customers via phone and email, collaborating with internal departments to resolve instrument issues, address customer inquiries, and identify potential sales opportunities. Worked closely with LIS vendors and facility IT departments to facilitate LIS setup and resolve connectivity issues.
Organized and documented all data obtained and troubleshooting actions performed during customer interactions in a detailed manner. Emphasized providing excellent customer service, building strong customer relationships, and ensuring a consistently positive customer experience throughout the customer journey.
Beckman Coulter Diagnostics
Hematology Instrumentation Technical Support Specialist
2020-2022 • Miami, Florida, USA
As part of the Honors College student project, Michaela collaborated with Chintan Bhatt, PhD Candidate at FIU College of Public Health. The projected aimed at analyzing data surveyed by the US Census, CDC, Florida Department of Health and published, peer-reviewed medical studies. From this data and findings, she assessed the social determinants of health of Miami Dade residents to compare the overall health of individuals at the county, state, and nationwide level.
Michaela presented her research findings at the Undergraduate Research Conference at FIU Spring 2017.
Florida International University
Honors College Research Student
2016-2017 • Miami, Florida, USA
Skills
English, Spanish (fluent)
G-Suite, Linux, MacOS, Microsoft Office
Laboratory Skills
Assays: ELISA, HPLC, LAL
Software/Platforms: Benchling, Labware LIMS, Chromeleon, SoftMaxPro, WinKQCL (Lonza)
Languages | Proficiency
SQL
Rscript
Python
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