Maria Castillo Raspopovich
Professional biochemical engineer experienced in IVD assay development, leading multiple sections of several assay development projects in R&D... | San Diego, California, United States
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Maria Castillo Raspopovich’s Emails ma****@ge****.com
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Maria Castillo Raspopovich’s Location San Diego, California, United States
Maria Castillo Raspopovich’s Expertise Professional biochemical engineer experienced in IVD assay development, leading multiple sections of several assay development projects in R&D and Operations Technical Support (under development & GMP environments). Experienced in assay development of amplified, nucleic acid based assays starting from project concept, feasibility, development & optimization on automated platform (TIGRIS), reagent formulation, specification setting, clinical trials, FDA submission, product launch and transfer to manufacturing. Experienced on technology transfer & evaluation, product development and validation for medical devices under EU/FDA regulations. Lead scientific role of Isothermal Transcription-Mediated Amplification for detection of multiple analytes. Designed protocols/procedures, trained internal & external customers and clinical site technicians. Exceptional experimental design & communicator of results in order to gain FDA approval for product commercialization in biotech and diagnostic industry. SPECIALTIES: R&D, molecular IVD assay development, DNA & RNA nucleic acids analysis (amplification, hybridization, labeling, conjugation, qPCR, sample quantitation), reagent formulation, specification setting, clinical samples, medical devices, clinical trials (set up, training, troubleshooting, monitoring), automated platform integration, troubleshooting, DOE, statistical analysis, microbiology, sequencing & sample preparation, IEx & RP- HPLC, mass spectrometry, CE, chromatography, technology transfer & evaluation, product & process development and improvement (scale up), process control, failed investigations, product support, hands-on and supervisory experience, failed investigations, data analysis, validation (IQ, OQ, PQ, PPQ) & verification, cross-functional team, GMP, QSR, QMS, GLP, ISO 13485, 21 CFR Part 11, technical writing (test plans, protocols, reports, SOPs, QS, work instructions, manufacturing documents). Actively seeking new opportunities
Maria Castillo Raspopovich’s Current Industry Hologic
Maria
Castillo Raspopovich’s Prior Industry
Gen Probe
|
Hologic
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Work Experience
Hologic
Senior Chemist
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Gen Probe
Senior Research Associate
Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)
Gen Probe
Research Associate
Sun Jan 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 1998 00:00:00 GMT+0000 (Coordinated Universal Time)
Gen Probe
Senior Research Assistant II
Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time)
Gen Probe
Research Assistant I
Tue Jan 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Maria Castillo Raspopovich Email Addresses
FAQ About Maria Castillo Raspopovich
-
Maria Castillo Raspopovich is located at
San Diego, California, United States -
Maria Castillo Raspopovich is a
Professional biochemical engineer experienced in IVD assay development, leading multiple sections of several assay development projects in R&D and Operations Technical Support (under development & GMP environments). Experienced in assay development of amplified, nucleic acid based assays starting from project concept, feasibility, development & optimization on automated platform (TIGRIS), reagent formulation, specification setting, clinical trials, FDA submission, product launch and transfer to manufacturing. Experienced on technology transfer & evaluation, product development and validation for medical devices under EU/FDA regulations. Lead scientific role of Isothermal Transcription-Mediated Amplification for detection of multiple analytes. Designed protocols/procedures, trained internal & external customers and clinical site technicians. Exceptional experimental design & communicator of results in order to gain FDA approval for product commercialization in biotech and diagnostic industry. SPECIALTIES: R&D, molecular IVD assay development, DNA & RNA nucleic acids analysis (amplification, hybridization, labeling, conjugation, qPCR, sample quantitation), reagent formulation, specification setting, clinical samples, medical devices, clinical trials (set up, training, troubleshooting, monitoring), automated platform integration, troubleshooting, DOE, statistical analysis, microbiology, sequencing & sample preparation, IEx & RP- HPLC, mass spectrometry, CE, chromatography, technology transfer & evaluation, product & process development and improvement (scale up), process control, failed investigations, product support, hands-on and supervisory experience, failed investigations, data analysis, validation (IQ, OQ, PQ, PPQ) & verification, cross-functional team, GMP, QSR, QMS, GLP, ISO 13485, 21 CFR Part 11, technical writing (test plans, protocols, reports, SOPs, QS, work instructions, manufacturing documents). Actively seeking new opportunities Hologic -
Maria Castillo Raspopovich currently works in the
Hologic -
Maria Castillo Raspopovich specializes in
Professional biochemical engineer experienced in IVD assay development, leading multiple sections of several assay development projects in R&D and Operations Technical Support (under development & GMP environments). Experienced in assay development of amplified, nucleic acid based assays starting from project concept, feasibility, development & optimization on automated platform (TIGRIS), reagent formulation, specification setting, clinical trials, FDA submission, product launch and transfer to manufacturing. Experienced on technology transfer & evaluation, product development and validation for medical devices under EU/FDA regulations. Lead scientific role of Isothermal Transcription-Mediated Amplification for detection of multiple analytes. Designed protocols/procedures, trained internal & external customers and clinical site technicians. Exceptional experimental design & communicator of results in order to gain FDA approval for product commercialization in biotech and diagnostic industry. SPECIALTIES: R&D, molecular IVD assay development, DNA & RNA nucleic acids analysis (amplification, hybridization, labeling, conjugation, qPCR, sample quantitation), reagent formulation, specification setting, clinical samples, medical devices, clinical trials (set up, training, troubleshooting, monitoring), automated platform integration, troubleshooting, DOE, statistical analysis, microbiology, sequencing & sample preparation, IEx & RP- HPLC, mass spectrometry, CE, chromatography, technology transfer & evaluation, product & process development and improvement (scale up), process control, failed investigations, product support, hands-on and supervisory experience, failed investigations, data analysis, validation (IQ, OQ, PQ, PPQ) & verification, cross-functional team, GMP, QSR, QMS, GLP, ISO 13485, 21 CFR Part 11, technical writing (test plans, protocols, reports, SOPs, QS, work instructions, manufacturing documents). Actively seeking new opportunities -
Maria Castillo Raspopovich speaks the following languages:
No languages available. -
Maria Castillo Raspopovich has prior experience in the following industries:
Hologic , Gen Probe , Gen Probe , Gen Probe , Gen Probe -
Maria Castillo Raspopovich has the following professional experience:
Hologic , Gen Probe , Gen Probe , Gen Probe , Gen Probe . -
You can view Maria Castillo Raspopovich’s
LinkedIn profile at LinkedIn URL. -
Maria Castillo Raspopovich’s work email addresses are
[email protected] . -
Maria Castillo Raspopovich works at
Hologic
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