Alba Levitas

Alba Levitas Email and Phone Number

Director, Assay Development at Cepheid @ Cepheid
sunnyvale, california, united states
Alba Levitas's Location
Sunnyvale, California, United States, United States
Alba Levitas's Contact Details

Alba Levitas personal email

n/a
About Alba Levitas

Alba Levitas is a Director, Assay Development at Cepheid at Cepheid. She possess expertise in gmp, assay development, molecular biology, fda, cell culture and 12 more skills.

Alba Levitas's Current Company Details
Cepheid

Cepheid

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Director, Assay Development at Cepheid
sunnyvale, california, united states
Website:
cepheid.com
Employees:
2630
Alba Levitas Work Experience Details
  • Cepheid
    Director, Assay Development
    Cepheid Mar 2024 - Present
    Oversee the development of a multiplex molecular in vitro diagnostic test using the next generation of high-performance Complementary Metal Oxide Semiconductor (CMOS) Biochip.
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  • Cepheid
    Sr Manager, Research & Development
    Cepheid Jun 2021 - Apr 2024
    - Manage the design and development of the Xpert Omni CoV-2/Flu/RSV assay on Omni Systems. - Lead and develop a team of 4 Scientists- Collaborate effectively with cross-functional team to meet deliverables, communicate scope change and provide risk assessments.- Plan, monitor, implement and oversee research activities related to the development of the Xpert Omni Cov-2/Flu/RSV product. Monitor team metrics and objectives ensuring meeting of goals.- Coordinate, provide technical guidance and strategies for the performance evaluation of the MTB/RIF Ultra V2 assay on hardened Omni systems.
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  • Cepheid
    Senior Scientist Ii, Research & Development Infectious Disease
    Cepheid Mar 2021 - Jun 2021
    Sunnyvale, California, United States
    - Manage the design and development of the Xpert Omni MTB-RIF Ultra V2 assay. - Lead and develop a team of 4 Scientist- Collaborate effectively with cross-functional team to meet deliverables, communicate scope change and provide risk assessments.
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  • Cepheid
    Senior Scientist, Research And Development Infectious Disease
    Cepheid Mar 2019 - Mar 2021
    Sunnyvale
    - Responsible for developing, planning and providing scientific inputs, feedback and directions on development of the GeneXpert® Omni, a portable molecular diagnostic system. - Responsible for planning and performing experiments, and providing strategies during concept, technical feasibility, D&D and validation phases for Xpert Omni MTB-RIF Ultra V2 assay.- Support the development of the point of care diagnostic assay (EUA) for Xpert®Omni SARS-CoV-2
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  • Cepheid
    Scientist Ii, Research And Development Oncology
    Cepheid May 2016 - Mar 2019
    - Responsible for design and develop of novel Oncology IVD molecular based assay for identifying and characterizing cancer. - Worked on testing and validating cancer targets and developing integrated sample preparation. Initial application is to detect circulating tumor DNA EGFR mutations and deletions in plasma and FFPE, and hematologic malignancy.- Finalized product development, process validation and scale-up production to transfer Xpert BCR-ABL Ultra assay from the R&D to production, following QSR, Design Control System, and cGMP/ISO guidelines.- Executed and designed the analytical studies and documentation to support the FDA 510(K) submission for the Xpert BCR-ABL Ultra assay product.
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  • Cepheid
    Scientist, Research And Development Oncology
    Cepheid May 2013 - May 2016
    - Significant member of a team responsible for developing a highly sensitive and accurate BCR-ABL assay that can detect a 4.5 log reduction. - Executed and designed the analytical studies and documentation to support the DIR, RUO/IUO and CE-IVD product launch, and FDA 510(K) submission for the Xpert BCR-ABL Ultra assay product. - Worked closely with project management, manufacturing, product transfer, quality and marketing to set schedules and timelines for the BCR-ABL Ultra Assay product development, participating in the Core Team meetings.- Present weekly project updates at technical meetings and maintain detailed experimental records. - Evaluated and optimized various cartridge configurations, sample processing, buffer formulations and fluidics for optimal RNA isolation and downstream efficiencies.
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  • Cepheid
    Associate Scientist, Research And Development Oncology
    Cepheid Jul 2010 - May 2013
    - Key responsibility in the area of real-time PCR assays using the Cepheid’s GeneXpert systems. Involved in all aspects of assay development and optimization. - Integral part of a team responsible for updating the Xpert BCR-ABL Monitor test, which reports results to the International Scale. The test was released as a European CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices.- Present weekly project updates at technical meetings and maintain detailed experimental records. - Generate and review SOPs and worksheets in compliance with standards for CGMP, ISO and FDA.
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  • Cepheid
    Manufacturing Chemist, Production
    Cepheid Jun 2007 - Jul 2010
    - Manufactured and tested all reagents for IVD, ASR, CSR, RUO, Biothreat Tests and Industrial Reagent products such as MRSA, MRSA/SA, HemosIL, GBS, Enterovirus, Flu A/B, BCR-ABL, TB, Ba 4-plex, SmartMix, bulk liquid reagents and calibrations dyes - Followed generated reports for investigational studies, method validation, and method transfer - Generated procedures and worksheets, in compliance with standards for cGMP, ISO and FDA- Reviewed procedures and data packages for accuracy and cGMP compliance- Performed all in-process, release and LSP testing for beads at all stages of the manufacturing process, in compliance with standards for cGMP, ISO and FDA
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  • Cepheid
    Test Operator, Production
    Cepheid Dec 2005 - May 2007
    - Perform routine release testing at all stages of the manufacturing process.- Follow established documentation outlining the process and test requirements to manufacture PCR-based products in compliance with standards for GMP
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  • Fertil – Urology, Gynecology And Fertility Center, Niteroi, Rj, Brazil
    Embryologist
    Fertil – Urology, Gynecology And Fertility Center, Niteroi, Rj, Brazil Feb 2000 - Feb 2005
    • Responsible for sperm capacitation for intrauterine insemination (IUI), in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI). • Sperm analysis included: sperm concentration, motility, morphology, vitality and white blood cells. • Sperm functional testing included: capacitation, Kruger (strict) morphology, Penetration Assay, antisperm antibody analyses, viability (hypo-osmolar test), and cervical mucus analyses.
  • State University Of Rio De Janeiro
    Adjunct Professor
    State University Of Rio De Janeiro Jan 2003 - Dec 2003
    Taught Cellular Biology at undergraduate level
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  • Estacio De Sa University
    Adjunct Professor
    Estacio De Sa University Jul 2001 - Dec 2001
    • Taught Embryology at post-graduate level

Alba Levitas Skills

Gmp Assay Development Molecular Biology Fda Cell Culture Laboratory Cell Elisa Rt Pcr Cell Biology Biotechnology Medical Devices Validation Immunoassays Antibodies Pcr Life Sciences

Alba Levitas Education Details

Frequently Asked Questions about Alba Levitas

What company does Alba Levitas work for?

Alba Levitas works for Cepheid

What is Alba Levitas's role at the current company?

Alba Levitas's current role is Director, Assay Development at Cepheid.

What is Alba Levitas's email address?

Alba Levitas's email address is al****@****.com.br

What schools did Alba Levitas attend?

Alba Levitas attended State University Of Rio De Janeiro, State University Of Rio De Janeiro, Universidade Do Estado Do Rio De Janeiro.

What skills is Alba Levitas known for?

Alba Levitas has skills like Gmp, Assay Development, Molecular Biology, Fda, Cell Culture, Laboratory, Cell, Elisa, Rt Pcr, Cell Biology, Biotechnology, Medical Devices.

Who are Alba Levitas's colleagues?

Alba Levitas's colleagues are Anu Hiremat, Lee Patrick, Terri Aziza, Rosamir Arradaza, Jayshree Meshram, Sharon Deng, Satya Ashok Kumar.

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