CAREER OBJECTIVE:

• To become a key member of a core development groupemphasizing on the development of IVDs and similar molecular diagnostic tools and products.
• Over 5 years of Confidential assay development experience focusing on liquid biopsy, Confidential, and other challenging molecular diagnostics assays.
• Held leadership roles in product development includingdesign, optimize, and launch of commercial Confidential assays with stringent timelines in both small and high - throughput Confidential environment.
• Currently serving as interim project leader of liquid biopsy project, emphasizing high sensitivity detection with low amounts of inputs.
• Experienced in designing, characterizing, and optimizing assay protocols, workflows, establishing QC protocols, providing and implementing on-going assay version updates and improvements.
• Experienced with analytical skills for analyzing large set of complex data with statistical methodology and approaches.
• Ability to recognize, understand, and troubleshoot problems.
• Experienced in designing and implementing workflow automation from simple sample preparation such as nucleic acid isolation to more complex library preparation and enrichment protocols.
• Optimization of wide range of Confidential -based assays including both amplicon-based assays and capture based assays, as well as RT-PCR, ddPCR, and microarray assays.
• Experienced in designing validations for submission to Confidential and NY.
• Experience with on-going support of released and transferred assays of commercial operations.
• Lead roles in Assay Development & Optimization & Validation
• Assay Clinical Validation &Transfer in Confidential regulated environment
• Lead roles in Confidential -based assay development of a lung/solid/ Confidential panel for liquid biopsy with high sensitiy focus (0.1% AF) with incoporation of UMIs
• Design, create, and management of work instructions(protocols), and worksheets to support each assay launched and transferred to commercial operations. Worksheets improve tracilibility, workflow efficiency, quality control and documentation.
• Ability to be robust, work well independentely, colloraboratively and have ability to delegate work efficiently.
• Familiar with multiple types of nucleic acid isolation platforms - Automation/Manual: QiagenSymphany/Viral, Thermo Kingfisher/Magmax, ChemagenChemagic 360 for cfDNA; MagNAPure/Qiagenallprep for Confidential nucleic acids.
• Solve complex, interdisciplinary technology and product development problems
• Very proficient with data management, and presentations with Excel and Powerpoint.
• Strong analytical &communication skills
• Strong critical thinking & problem solving skills.
• Attention to details.
• Strong Confidential background
• Strong Automation background
• Experience in GLP, GMP, and Confidential Settings
• Mathematica, SerialCloner, Geneious, C, Adobe Suite, LIMs, R, Illumina SAV

PROFESSIONAL EXPERIENCE:

Associate Scientist

Confidential

Responsibilities:

• Assay targeting most clinical actionable driver genes across over 100kb of ROI.
• Designed, developed, optimized, qualified, and managed the high sensitivity Confidential project.
• Assay Desgin & Assay Optimization
• Low input and high limits of detection able to detect variants with AF<0.1%.
• Targeted variants includes Confidential, Indels, CNVs, and Translocations.
• Implementation and optimization of Unique Molecular Identifiers and post-sequencing bioinformatic processes.
• Initial POC and feasibility study start with a scaled-down smaller panel
• Automation of pre-analytical sample preparation(nucleic acid isolation) & automation of library preparation and target enrichment protocols and pre-sequencing protocols.
• Optimization of conversion rates, design and optimization of post-library enrichment processes.
• Implementation of quality control processes and setting thresholds.
• Lead in project for writing, developing, and maintaining worksheets for Confidential that Confidential end users can rely on to properly record and document the details of their assay workflow, calculate mastermixes, platforms for normalization of samples, assignments of indexed barcodes, and pooling and loading strategies for Confidential .

Senior Research Associate

Confidential

Responsibilities:

• Assisted and took some leads in research, design, proof of concept and feasibility studies, optimization, and validation of various custom panels consisting of 10-200 of the most relevant and actionable cancer genes.
• Designed Confidential utilizes both amplicon-based and target capture based methods of enrichment, depending on size and enrichment/target strategies.
• Sample preparation across multiple specimen types such as blood/plasma, and Confidential with various automated sample isolation platforms.
• Both manual and automated methods of Confidential library preparation are developed, optimized, and utilized, including writing custom in-house protocols for Hamilton STARs and Agilent Bravos to execute and perform them.
• Sequencing are performed on various Confidential platforms. Sequencing data are analzyed through custom pipeline and third party softwares, variants are analyzed along with quality and coverage data to call both novel and characterized Confidential, Indels, CNVs, and Translocations.
• Comprehensively evaluate and document the quantitative performance of the assay, including sensitivity, specificity, accuracy, precision, detection limit, range, and limits of quantification. Inter-assay and Intra-assay assessment of assay robustness, and testing sample robustness.
• Validation of Confidential for Confidential use with NY submission including all aspects of technical assessments, clinical assessments, and orthogonal confirmations.
• Lead in project for writing, developing, and maintaining worksheets for Confidential that Confidential end users can rely on to properly record and document the details of their assay workflow, calculate mastermixes, platforms for normalization of samples, assignments of indexed barcodes, and pooling and loading strategies for Confidential .
• Lead in project for developing and launching automated Confidential library preparation platforms using Hamilton STARs and Agilent Bravos. Improve CV in previous protocols by optimizing liquid class profiles.

Clinical Laboratory associate

Confidential

Responsibilities:

• Operated all aspects of day-to-day operations in the Confidential lab for non-invasive fetal genetic assay Confidential to determine the presence of polyaneploidy in chromosome 13, 18 and 21 from high risk pregnant women by:
• Free circulating fetal nucleic acid isolation.
• Semi-automated 96-well high throughput library preparation.
• Library QC with Labchip GX.
• Multiplexing on Liquid handler(EpMotion).
• Clustered libraries are sequenced on Confidential .
• Collaboration with R&D for 3 months to implement the semi-automated Confidential library preparation process rolled out for V2 of Confidential .

Senior laboratory associate

Confidential

Responsibilities:

• Worked closely with scientists in designing and optimizing the heterologous expression of novel proteins(i.e. insulin, single-chain fv) and drugs in simpler biological host systems in a GMP certified fermentation lab:
• Utilizing many molecular biology methods to increase solubility of insoluble proteins/drugs such as the use of phages infections and fusion of target proteins to a solubility enhancing protein.
• Develop and implement strategic genetic cloning techniques to develop individual strains:
• Design primers and oligonucleotides for PCR, incorporting leader sequences and fusion proteins.
• Performed a broad range of molecular biology and chemistry techniques:
• Expression, restriction digestion, and ligations. Gel quantification and gel purification.
• Protein expression screening, protein purification using HPLC.
• Scaling up with high volume fermenter for GMP production.

Research Associate

Confidential

Responsibilities:

• Market research for colorimetric metabolism assays.
• Designed, developed, and optimized metabolism colorimetric assay kits, performed testing for limits of detection, stability testing, accuracy and precision studies.
• Writing and developing SOPs for each assay to include all proper documentation.
• IPTG-induced protein expression screening of over hundreds of human kinases, protein profiling by SDS-PAGE and Sanger sequencing.
• Cloning, isolation and analysis of recombinant DNA.
• DNA Sanger sequencing using 3730 abi platform.
• Troubleshooting with customers regarding SOPs and general issues with assays.