Krsna Vieira
Gaithersburg
Summary
Results-focused and meticulous biotech professional with strength in molecular biology, microbiology and cell-based assays. Also a proactive team member with strengths in development and qualification of analytical methods and collaboration with cross-functional groups. Adept at managing concurrent objectives to promote efficiency and influence positive outcomes.
Overview
15
15
years of professional experience
Work History
Senior Process Development Associate
Miltenyi Biotec/Lentigen
01.2025 - Current
- Lead the development and qualification a genome titer ddPCR assays for internally developed lentiviral vector products.
- Successfully adapted and qualified a RT-ddPCR assay for the application of novel lentiviral genome integrity and safety method for lot release of clinical-stage drug substance.
- Author SOPs, development, and qualification reports.
Process Development Associate I
Miltenyi Biotec/Lentigen
06.2022 - 12.2024
- Spearheaded effort to develop a rapid vector genome titer method for lentiviral products.
- Assisted in development in an analytical method for characterization of residual DNA size of lentiviral products.
- Execute assays to characterize processes such as (qPCR, ddPCR, ELISA, Total Protein, Total DNA, fragment analyzer).
- Train junior members in all aspects of current responsibilities.
- Carry out tasks in support of on-going experiments and runs in process development.
Associate Scientist
American Gene Technologies Inc.
04.2019 - 06.2022
- Supported pre-clinical development of cell and gene therapy products, IND-enabling studies, and standardization of procedures and protocols.
- Developed, troubleshooted, and qualified bioanalytical assays; facilitated the transfer of assay procedures to external partners.
- Contributed to quality control for release of cell products in Phase I trial.
- Reviewed and authored SOPs, technical reports, and protocols.
- Collaborated on translational research plans for transitioning from Research & Development to preclinical studies to support company pipeline.
- Communicated effectively with cross-functional groups, including Quality Assurance, Clinical Development, and R&D.
- Demonstrated expertise in qPCR optimization, PCR, cell culture/cell-based assays, ELISA, Flow Cytometry, Western blots, and Lentiviral Titering.
- Achievements:
- Played a key role in the successful launch of clinical trials for HC168: "Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy, IND 19299, NCT04561258."
Senior Laboratory Technician
VRL Laboratories
08.2015 - 03.2019
- Conduct pre-designed assays using basic laboratory techniques and skills, conduct assigned test procedures within time constraints of lab scheduling, and manage inventory of cell lines, viruses and bacteria.
- Provide diagnostic results for VRL Animal Health Services Division in compliance with industry standards and Good Laboratory Practices (GLP).
- Perform animal necropsy, dissection, and sample collection.
- Extract and purify DNA, RNA, and total nucleic acid from fecal matter, swabs, cell lines, tissue sections for PCR-based diagnostic testing.
- Production of qualified lots of viral stocks and infected cell lines for ELISA and IFA biochemical assays.
- Review, edit, and write Standard Operating Procedures (SOPs).
Research Assistant
Food & Drug Administration
08.2010 - 12.2012
- Maintenance and calibration of Tempo HPLC/MALDI target plate deposition hybrid instrument for MALDI TOF/TOF analysis.
- Participated in analytical protein methodologies-Protein and peptide characterization using reverse-phase HPLC and Mass spectrometry (nanoLC, MALDI-TOF/TOF).
- Maintenance of mammalian cell lines and aseptic technique.
- Conducted laboratory techniques for quantitative and qualitative purposes including, Western Blots, ELISA, PCR, gel-free fractionation, hydrostatic protein extraction, hemagglutination inhibition assays.
- Effective collaboration with branch postdoc fellows in their research projects: Qualitative analysis of CYPs expression, proteome analysis of hBMSCs, proteomic profiling of multipotent stem cells, characterization of influenza antigens.
Education
Bachelor of Science - Biological Sciences
University of Maryland - Baltimore County
Baltimore, MDSkills
- QPCR, ddPCR
- Cell line and primary cell culture
- In-Situ Hybridization
- RNA/DNA Isolation & Analysis
- Flow Cytometry
- Technology Transfer
- Assay development/qualification
- Data Analysis: JMP
Timeline
Senior Process Development Associate
Miltenyi Biotec/Lentigen
01.2025 - Current
Process Development Associate I
Miltenyi Biotec/Lentigen
06.2022 - 12.2024
Associate Scientist
American Gene Technologies Inc.
04.2019 - 06.2022
Senior Laboratory Technician
VRL Laboratories
08.2015 - 03.2019
Research Assistant
Food & Drug Administration
08.2010 - 12.2012
Bachelor of Science - Biological Sciences
University of Maryland - Baltimore County