ABI Companion resume examples

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Skillful ABI Companion resume

Job Soberano
Professional Summary
Enthusiastic RN with excellent people skills and dedicated work ethic. Demonstrate medical procedure competency.
Licenses
  • Registered Nurse in the State of Texas, License number 911966, 2016-2018 
  • Basic Life Support (BLS) Certification ECard No:165504154988, 2016-2018
Professional Experience
Patient Care Companion, 07/2016 to 01/2017 CHI St. Luke's Medical Center Houston, Texas

 

Bathing, Cleaning, Shaving, Feeding, Positioning, Bed making, Vital Signs, Measure Intake and Output, Check Blood Sugar.

RN(Medical Surgical, Orthopedics, Pediatrics, Psychiatric, PACU), 08/2015 to 12/2015 West Visayas State University Medical Center Iloilo, Philippines

 

Managed care for post-operative patients through discharge. Instructed patients and family members on proper discharge care. Closely monitored acute conditions. Monitored patient reactions to drugs and carefully documented progress of individuals. Developed and implemented nursing care plans. Made appropriate interventions by reading and interpreting heart monitors.

Skill Highlights
  •  Acute care expertise
  • Patient/family focused
  • In-depth knowledge of intravenous therapy
  • Proper catheter insertion/removal
  • Qualified critical care nurse
  • Professional bedside manner
  • Thorough physical assessments
  • Patient positioning competency
Education and Training
Bachelor of Science: Nursing, 2011 STI West Negros Bacolod City, Philippines
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Job-winning ABI Companion resume

Seth Yu PHD
Executive Profile
A seasoned science-driven director-level program leader in IVD diagnostics & companion diagnostics development, strategy and technology management (15y), with drug development experience (6y), achieving numerous on-time successful commercial Dx launches and global CTA/CDx implementations in drug trials, as a motivating team and relationship builder effectively multitasking in dynamic cross-functional environment.
Skill Highlights
  • Technology management & competitive intelligence 
  • Intelletual property qualification
  • IVD Dx/CDx development leader
  • Program portfolio manager for planning budgeting
  • Motivating team builder and leader
  • Partnership skills (KOL PI vendor CRO ref labs)
  • Process streamline improvement initiatives
  • Oncology neuroscience infectious disease versed
  • Genomics genetics & signal transduction trained
  • GLP/GMP/ISO/GCP/CLIA/CAP proficient
  • Six-sigma & lean 5S trained
  • FDA IDE/PMA submission & F2F experience 
  • NGS IHC NAT (qPCR, ddPCR) device familiarity
  • Global implementation of devices in drug trials 
Core Accomplishments
Diagnostics/Companion Diagnostics Product Development:
  • Successfully launched 10 diagnostics products (NAT) as program leader
  • On-time launch of 2 oncology clinical trial assays (CTAs) (NAT) with FDA-approved IDEs with assays implemented globally.
  • Led development validation and verification of a semi-automated. epigenetic companion diagnostic system for Fragile X syndrome.
  • Led development of an IHC test for breast cancer.
  • Led custom-development validation of an NGS (RNA Seq) assay
Technology Management:
  • Assessed and advised on three 
People Management:
  • [yes sir]
  • [yes maam]
Financial Management:
  • [very good]
  • [cool]
Research
  • Conducted research which led to the development of [program].
Professional Experience
Senior Fellow, Associate Director, Companion Diagnostics Developmen 11/2009 to 09/2016 Novartis Oncology Precision Medicine Cambridge, MA
Development Manager, Diagnostics Product Development 02/2004 to 02/2009 Cepheid Sunnyvale, CA
Consultant 02/2002 to 02/2004 Threshold Pharmaceuticals Redwood City, CA

Intellectual Property and Licensing.

Head of Technology Office Asia Pacific; Principal, Technology Management 02/1999 to 02/2002 Roche Diagnostics Corporation Berkeley, CA
Staff Scientist, Postdoctoral Fellow 07/1995 to 02/1999 Novartis Institutes for BioMedical Research Chiron Corp Emeryville, CA
Principal Research Manager Diagnostics New Technology
Novartis Oncology Precision Medicine and Companion Diagnostics
  • Cross-functional Precision Medicine/Companion Diagnostics operational leader for clinical trial assay and companion diagnostics development in Oncology and Neuroscience - leading a technical team and the program team including members from regulatory, quality, clinical trial management, systems, pilot production, quality control, software developer, and drug development team, under regulated environment (GMP, GLP, GCP, CLIA, CAP, ISO & Design Control), leading to IDEs and PMAs (co-filing with INDs):.
  • Led the assay development of an IHC diagnostic as a breast cancer metastasis indicator (SATB1), and terminated the program after the developed assay disproving licensed biomarker indication, and further clinical utility exploration in prostate cancer.
  • Systematic technical/quality assessments and recommendations of potential world-wide testing reference labs and CROs for various Novartis oncology programs including pharmacogenetic testing platform and technology for Biomarkers.
  • Designed and led development/analytical validation/launch of an FDA IDE-approved registrational clinical trial assay (a real-time RT-PCR RNA test for an oncogenic driver MET mutation), to aid in Novartis drug INC280 treatment decision for non-small cell lung cancer (FFPE samples), demonstrating perfect concordance with a custom-developed NGS (RNA Seq) and with NanoString assays in over a hundred clinical samples.
  • Led manufacturing transfer, streamlined manufacturing process and internal manufacturing troubleshooting.
  • Designed and led development/validation/launch of an FDA IDE-approved registrational clinical trial assay and subsequent development of companion diagnostic (a semi-automated real-time PCR epigenetic DNA methylation test for FMR1 promoter), to aid in Novartis drug AFQ056 treatment decision for Fragile X Syndrome (whole blood samples) with regulatory submission and face-to-face FDA meeting experience.
  • Led manufacturing transfer, vendor selection qualification, and manufacturing troubleshooting at an external vendor.
  • Led a custom NGS (RNA Seq) assay development, including analytical validation and clinical sample testing on Illumina MySeq platform.
  • Led development of a clinical trial assay (a real-time PCR DNA test for FGFR3 mutations) to aid in Novartis drug BGJ398 treatment decision for bladder cancer (FFPE samples).
  • Led development and validation of ancillary QC test methods for all developed CTAs and CDx.
  • Assay transfers to pilot production, and diagnostic tests implementation transfers to US and international clinical testing sites in Europe and Asia.
  • Clinical trial testing sites initiation, monitoring, and closeout visits, KOLs and investigators meeting, clinical trial protocols, assay performance monitoring and proficiency qualification, quality and technical site audits.
  • Versed in Design Control Process including stage gates, validation, verification, bridging, doc control, environment control, equipment validation, traceable requirements, design development planning, and risk management including FMEAs.
  • Versed in six sigma methodology including VOC DOE for assay development and spec robustness, process map and troubleshooting methodologies like fishbone analysis.
  • Precision medicine projects: scientific planning, budgeting, quarterly resource and cost tracking.
  • Process improvement in organizational initiatives for efficiency optimization through authoring high-level guideline documents streamlining complex processes with alignment from different functions.
  • Participation in development of reimbursement and cost strategy with external consultants for companion diagnostics.
  • Cepheid.
  • Program and technical leader of a multidisciplinary team for the integrated microfluidics platform-based assay development with commercial launches of diagnostic products for: Norovirus; Respiratory Syncytial Virus (RSV); Flu A/B; Herpes Virus Typing.
  • Technical leader for oncology diagnostic launch of the industry-only sample-in-answer-out GeneXpert BCR-ABL CML monitor test, from design to quantitative assay development, interfacing with software developer system engineers for system integration in a fully-automated microfluidic device.
  • Designed, developed and validated diagnostic tests for virus detection in hemorrhagic fevers (Ebola, Lassa, and Marburg) and led partnership with Health Canada under Canadian CRTI initiative.
  • Company-appointed liaison as 1 of 4 industry representatives in SPADA initiative, developing industry standards for Biothreat assays, commissioned by the Department of Homeland Security.
  • Program leader for design development of a scorpion chemistry-based GeneXpert Anthrax Test for U.S.
  • Postal Services, a product still in use without a false positive after 9 million tests.
  • Threshold Pharmaceuticals.
  • Member of a startup company portfolio management team for pre-clinical research programs.
  • Drafting and filing of patent applications and prior art search in cancer combination therapy.
  • Assessment of in-licensing opportunities and competitor landscape in cancer combination therapy based on hypoxia model in cancer.
  • Roche Diagnostics.
  • Team manager for new diagnostics technology laboratory evaluations in real-time PCR platform comparison, microarrays comparison, and in-vitro cell-free protein synthesis systems.
  • Liaison to outreach technology transfer offices in key US academic institutions for medical diagnostics innovations.
  • Authored several white paper reports of competitive landscape in diagnostics fields.
  • Technology scouting/management for external innovations in both Region Asia Pacific and US.
  • Appointed Head of Technology Office Region Asia/Pacific overseeing 14 countries/regions for new technology scouting and developing regional strategy based on diverse regulatory environment.
  • Championed internal drug target validation system program for Roche Pharma based on Roche Diagnostics competencies and systems.
  • Project leader for molecular diagnostic test development to aid in treatment decision of Roche cancer drug Xeloda for colorectal cancer.
  • Novartis Institutes for BioMedical Research.
  • Cancer MOA research (oncogene signal transduction, apoptosis, angiogenesis, and AAV-based gene therapy in pre-clinical studies) discovering a key phosphorylation MOA in MAP kinase pathway involving kinase-suppressor of Ras (Ksr).
  • Championed angiogenesis topic in cancer genomics/proteomics target discovery research using high-throughput sequencing and 2-D protein gel electrophoresis.
Education
Ph.D.: Molecular Biology University of Utah Salt Lake City, UT
Bachelor of Science: Biochemistry Fudan University Shanghai, China
USPTO-registered Patent Agent Practicing Law Institute San Francisco, CA
Publications
1. Yu, W. (Invited Review, 2006) "Molecular Testing: Clinical Diagnostics and Beyond", Trends Bio/Pharm. Ind.2, 33-38
2. Yu, W., Fantl, W.J., Harrowe, G. and Williams, L.T. (1998) "Regulation of the MAP Kinase Pathway by Mammalian Ksr through Direct Interaction with MEK and ERK", Curr. Biol. 8, 56-64
3. Yu, W., Farrell, R.A., Stillman, D.J. and Winge, D.R. (1996) "Identification of SLF1 as a New Copper Homeostasis Gene Involved in Copper Sulfide Mineralization in Saccharomyces cerevisiae", Mol. Cell. Biol. 16, 2464-2472
4. Thorvaldsen, J.L., Mehra, R.K., Yu, W., Sewell, A.K. and Winge, D.R. (1995) "Analysis of Copper-Induced Metallothionein Expression Using Autonomously Replicating Plasmids in Candida glabrata", Yeast 11, 1501-1511
5. Sewell, A.K., Yokoya, F., Yu, W., Miyagawa, T., Murayama, T. and Winge, D.R. (1995) "Mutated Yeast Heat Shock Transcription Factor Exhibits Elevated Basal Transcriptional Activation and Confers Metal Resistance", J. Biol. Chem. 270, 25079-25086
6. Yu, W., Santhanogopalan, V., Sewell, A.K., Jensen, L.T. and Winge, D.R. (1994) "Dominance of Metallothionein in Metal Ion Buffering in Yeasts Capable of Synthesis of (*EC)nG Isopeptides", J. Biol. Chem. 269, 21010-21015
7. Caticha, O., Grover, S., Yu, W. and Odell, W.D. (1994) "The Presence of a Human Chorionic Gonadotropin-like Protein and Its Binding Site in Saccharomyces cerevisiae", Endocr. Res. 20, 21-37
8. Winge, D.R., Sewell, A.K., Yu, W., Thorvaldsen, J.L., Yokoya, F., Farrell, R. (1994) "Metal Ion Stress in Yeast", in "Metal Ions in Gene Regulation" (W., Walden and S., Silver, eds), Chapman and Hall, New York
9. Yu, W., Macreadie, I.G. and Winge, D.R. (1991) "Protection against Cadmium Toxicity in Yeast by Alcohol Dehydrogenase", J. Inorg. Biochem. 44, 155-161
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Top ABI Companion skills

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Experienced ABI Companion resume

Jasmine Fredericks
Professional Summary

I am a highly effective at anticipating and accommodating customer needs. I am a friendly, punctual and enthusiastic team player. I have a lot of experience working in busy work environments. I have great communication and organization. I really enjoy working with others and also up for sharing and creating solutions/ideas. I would like to work with creative and interesting people and inspire to help and make a difference in my everyday work.

Core Qualifications
  • Organized and efficient server
  • Committed team player
  • Courteous, professional demeanor
  • Flexible schedule availability
  • Organized multi-tasker
  • Customer service
  • Quick learner
  • Well organized
Experience
Pride One (Contractor) January 2019 to September 2019 Implementation Specialist
Plano, TX
  • Merchant Services, Merchant Applications
  • Manage clear expectations and understanding by establishing clear timeline's and managing documentation requirements
  • Demonstrate creative problem solving and solid judgment/decision making
  • Exhibit adherence to policy and procedures and meet or exceed established Service Level Agreements
  • Ownership, escalation and resolution of risk issues when they occur in a timely manner
  • Exhibit ownership of on-boarding experience and client satisfaction
LA Burger August 2018 to December 2018 Cashier/Server
Carrollton, TX
  • Answering phones
  • Taking orders
  • Serving food, restocking and cleaning
Child Care April 2017 to June 2018 Sitter/ Companion
New York, NY
  • School Pick up
  • Overnight, Homework help
  • Activities: Museums, sports, cooking, board games
Sprinkles Cupcakes and Ice Cream May 2016 to February 2018 Ice Cream/Cupcake Associate
New York, New York
  • Worked as a team member performing cashier duties
  • Product assistance and cleaning
  • Delivering/Organizing orders
  • Responsible for ringing up customers in a timely manner and guaranteeing high level of customer service
Landmark Sunshine Cinema June 2016 to October 2016 Floor Staff
New York, New York
  • Theater announcements/ setting up for Movie premieres
  • Concessions
  • Processed admission payments and provided tickets
Club Monaco June 2012 to September 2012 Stock Associate
New York, New York
  • Greeted customers and ascertained customers' needs
  • Stocked shelves and supplies and organized displays
  • Organized racks and shelves to maintain the visual appeal of the store
Education
AMDA College and Conservatory of Performing Arts 2016 Bachelor Of Fine Arts: Performing Arts Dance Theater Los Angeles, CA, USA
Plano West Senior High 2012 High School Diploma Dallas, TX, USA
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