*Established, directed, and maintained an Assay Development/Research team consisting of molecular technologists to validate and perform clinical assays*Established validation plans for assays of interest*Provide assay validation plans, summaries and process SOPs*Worked with LIS developers to accommodate and report new assays*Work with Molecular Director to transition new assays into production*Provided weekly progress updates to CEO, COO, CCO, business partners and other… Show more *Established, directed, and maintained an Assay Development/Research team consisting of molecular technologists to validate and perform clinical assays*Established validation plans for assays of interest*Provide assay validation plans, summaries and process SOPs*Worked with LIS developers to accommodate and report new assays*Work with Molecular Director to transition new assays into production*Provided weekly progress updates to CEO, COO, CCO, business partners and other senior leadership team members*Worked with QA director and other departmental directors and supervisors to make sure that the laboratory is operating in compliance with clinical regulatory agency guidelines and requirements*Direct and perform validations at other laboratory sites (Irving, TX) when needed Show less

*Established detailed spreadsheets containing genes that increase risk for and genes that may confer protection from COPD, sarcoidosis, asthma and ILD*Performed literature/data reviews for < 200 pulmonary disorder (asthma, COPD, sarcoid and ILD) studies*Summarized pulmonary disorder study results from dbGAP for peer/PI review*Provided weekly updates for peer/PI review (telework)*Participated in monthly peer/PI progress review meetings*Established and supported AWS… Show more *Established detailed spreadsheets containing genes that increase risk for and genes that may confer protection from COPD, sarcoidosis, asthma and ILD*Performed literature/data reviews for < 200 pulmonary disorder (asthma, COPD, sarcoid and ILD) studies*Summarized pulmonary disorder study results from dbGAP for peer/PI review*Provided weekly updates for peer/PI review (telework)*Participated in monthly peer/PI progress review meetings*Established and supported AWS cloud-based database system for departmental use*Establish policies, procedures and standards related to research and database management Show less

*Directed project workflows and progress (monthly onsite visits) for molecular team*Established and directed a team of molecular technologists to validate and execute clinical assays*Worked with the LIS administrators to validate and implement LIS functionality*Updated the executive team regarding project progress in the molecular lab*Worked closely with GDL’s Medical Lab Director to make sure that the laboratory was operating in compliance with clinical regulatory agency… Show more *Directed project workflows and progress (monthly onsite visits) for molecular team*Established and directed a team of molecular technologists to validate and execute clinical assays*Worked with the LIS administrators to validate and implement LIS functionality*Updated the executive team regarding project progress in the molecular lab*Worked closely with GDL’s Medical Lab Director to make sure that the laboratory was operating in compliance with clinical regulatory agency guidelines and requirements*Worked with owner and leadership team to map out laboratory space (practical, unidirectional workflow)*Recommended equipment, reagents, consumables, etc. for use in the laboratoryReviewed laboratory performance and potential process improvements with molecular team, Laboratory Director and Executive Team Show less

*Directed a team of molecular technologists to validate and execute clinical assays*Worked with the Information Technology Team to validate and implement LIMS functions*Supervised the processing of clinical samples*Represented the genomics laboratory’s interests in meetings with the Management Team and the Sales and Marketing Teams *Worked closely with Quality Assurance consultant to make sure that the laboratory was operating in compliance with CLIA guidelines and… Show more *Directed a team of molecular technologists to validate and execute clinical assays*Worked with the Information Technology Team to validate and implement LIMS functions*Supervised the processing of clinical samples*Represented the genomics laboratory’s interests in meetings with the Management Team and the Sales and Marketing Teams *Worked closely with Quality Assurance consultant to make sure that the laboratory was operating in compliance with CLIA guidelines and regulations*Provided laboratory tours and explanations of laboratory workflow to prospective clients*Reviewed laboratory performance and potential improvements to processes with Medical Director Show less

*Directed a team of molecular technologists (PhD and M.S. level) to execute clinical workflow*Supervised accessions of patient information and the processing of clinical samples*Represented the laboratory’s interests in company meetings, etc.*Interacting with a team of medical and technical professionals to answer questions about samples processed in the lab*Worked closely with the Quality department to make sure that laboratory was operating in compliance*Supervised the… Show more *Directed a team of molecular technologists (PhD and M.S. level) to execute clinical workflow*Supervised accessions of patient information and the processing of clinical samples*Represented the laboratory’s interests in company meetings, etc.*Interacting with a team of medical and technical professionals to answer questions about samples processed in the lab*Worked closely with the Quality department to make sure that laboratory was operating in compliance*Supervised the establishment of new operations and workflows after Guardant Health purchased the Molecular Health laboratory*Conducted bi-weekly meetings to update project management and CA clinical operations teams regarding laboratory activities*Ordered supplies for and maintained the inventory necessary for day-to-day operations*Represented the laboratory in monthly QM review sessions where past performance and potential improvements to processes were discussed Show less

*Was responsible for organizing and establishing laboratory from the ground up*Hired and directed a team of molecular technologists (PhD, MS and BS level) to perform clinical assays using NGS and aCGH*Ordered and organized the implementation all laboratory equipment*Validated and transitioned the NGS assays into production within 3 months*Established and published all laboratory SOPs including NGS, aCGH and DNA/RNA extraction from FFPE and blood samples*Maintained service… Show more *Was responsible for organizing and establishing laboratory from the ground up*Hired and directed a team of molecular technologists (PhD, MS and BS level) to perform clinical assays using NGS and aCGH*Ordered and organized the implementation all laboratory equipment*Validated and transitioned the NGS assays into production within 3 months*Established and published all laboratory SOPs including NGS, aCGH and DNA/RNA extraction from FFPE and blood samples*Maintained service contracts and PM schedules*Working closely with QM Department to prepare the laboratory to receive the following licenses/accreditations:-CAP-CLIA (Certificate of Accreditation)-California, Florida, Maryland, Pennsylvania, Rhode Island-ISO 15189 Platinum Choice Program (at the time we were 1 of only 2 labs with this designation in the US)Daily responsibilities included but were not limited to the following:*Directed a team of molecular technologists and a histologist to make sure that end-to-end services were delivered per company’s published TAT schedule*Performed extensive bench work*Performed quality checks of sequencing data*Represented the US laboratory interests in company meetings, etc.*Validated and transitioned new clinical assays into production *Interacting with a team of medical professionals in the US and Germany to answer questions about samples processed in the lab*Worked closely with QM Director to make sure that laboratory is operating in compliance*Provided laboratory tours and explanations of laboratory workflow to prospective clients*Provided weekly updates to SVP of US Operations*Participated in monthly QM review sessions where past performance and potential improvements to processes were discussed Show less

Responsible for managing a team of licensed and non-licensed professionals in a department that was the primary revenue generator of the company; the department was responsible for developing, validating and performing PCR mutation assays, FISH assays and aCGH (DNA microarrays); the department was in the process of validating a cancer panel on the Ion-Torrent NGS platform; managed a budget of over $750,000 and reported to the Chief Technical Officer and the Senior Director of… Show more Responsible for managing a team of licensed and non-licensed professionals in a department that was the primary revenue generator of the company; the department was responsible for developing, validating and performing PCR mutation assays, FISH assays and aCGH (DNA microarrays); the department was in the process of validating a cancer panel on the Ion-Torrent NGS platform; managed a budget of over $750,000 and reported to the Chief Technical Officer and the Senior Director of OperationsDuties included but were not limited to the following:• Was responsible for staffing the department• Was responsible for evaluating, purchasing and making sure that all reagents used in the department were stored properly and current• Was responsible for interacting directly with vendors that serviced the department’s needs• Was responsible for developing, validating and transitioning all departmental assays into the clinical environment• Was responsible for departmental SOP development and implementation• Interacted directly with the QA department representatives to make sure that all licensing agency guidelines (CLIA, CAP, etc.) were being upheld• Interacted directly with the Bioinformatics department to ensure that all departmental needs were acknowledged and addressed• Was responsible for interacting directly with licensing agency representatives during site inspections• Was responsible for reviewing all reports that were generated by the department as a final line of quality control before they were forwarded to either the CTO, the medical director or the clients• Was responsible for interacting directly with the CEO, the CTO, the medical director and the sales force to determine what assays, etc. needed to be developed• Was responsible, along with the medical director and the CLSs, for interacting directly with clients about questions that they might have about their reports and/or results Show less

Responsible for managing a team of licensed and non-licensed professionals in a department that was the primary revenue generator of the company; the department was responsible for developing, validating and performing PCR mutation assays, FISH assays and aCGH (DNA microarrays); managed a budget of over $750,000 and reported to the Chief Technical Officer and the Senior Director of OperationsDuties included but were not limited to the following:• Was responsible for staffing… Show more Responsible for managing a team of licensed and non-licensed professionals in a department that was the primary revenue generator of the company; the department was responsible for developing, validating and performing PCR mutation assays, FISH assays and aCGH (DNA microarrays); managed a budget of over $750,000 and reported to the Chief Technical Officer and the Senior Director of OperationsDuties included but were not limited to the following:• Was responsible for staffing the department• Was responsible for evaluating, purchasing and making sure that all reagents used in the department were stored properly and current• Was responsible for interacting directly with vendors that serviced the department’s needs• Was responsible for developing, validating and transitioning all departmental assays into the clinical environment• Was responsible for departmental SOP development and implementation• Interacted directly with the QA department representatives to make sure that all licensing agency guidelines (CLIA, CAP, etc.) were being upheld• Interacted directly with the Bioinformatics department to ensure that all departmental needs were acknowledged and addressed• Was responsible for interacting directly with licensing agency representatives during site inspections• Was responsible for reviewing all reports that were generated by the department as a final line of quality control before they were forwarded to either the CTO, the medical director or the clients• Was responsible for traveling to professional conferences and reporting trends and potential new assay development back to upper management• Was responsible for interacting directly with the CEO, the CTO, the medical director and the sales force to determine what assays, etc. needed to be developed• Was responsible, along with the medical director and the CLSs, for interacting directly with clients about questions that they might have about their reports and/or results Show less

Responsible for managing research scientists; the department was primarily responsible for developing aCGH assays (constitutional and oncology) and transitioning them into the clinical environment by developing the SOPs and training the CLSs to perform the assays; reported directly to the VP of Scientific Affairs and the CEODuties included but were not limited to the following:• Was responsible for designing experiments that would allow us to evaluate and validate new assays… Show more Responsible for managing research scientists; the department was primarily responsible for developing aCGH assays (constitutional and oncology) and transitioning them into the clinical environment by developing the SOPs and training the CLSs to perform the assays; reported directly to the VP of Scientific Affairs and the CEODuties included but were not limited to the following:• Was responsible for designing experiments that would allow us to evaluate and validate new assays, equipment and reagents• Was responsible for evaluating, purchasing and making sure that all reagents used in the department were stored properly and current• Was responsible for interacting directly with vendors that serviced the department’s needs• Was responsible for developing, validating and transitioning all departmental assays into the clinical environment• Was responsible for departmental SOP development and implementation• Interacted directly with the Bioinformatics department to ensure that all departmental needs were acknowledged and addressed• Was responsible for traveling to professional conferences and reporting trends and potential new assay development back to upper management• Was responsible, along with the VP of Scientific Affairs and the Bioinformatics department for new assay development Show less

Responsible for managing research technicians and interacting with other research factions; the department was primarily responsible for developing aCGH assays (constitutional and oncology) and transitioning them into the clinical environment by developing the SOPs and training the CLSs to perform the assays; reported directly to the Departmental DirectorDuties included but were not limited to the following:• Was a part of a team responsible for designing experiments that would… Show more Responsible for managing research technicians and interacting with other research factions; the department was primarily responsible for developing aCGH assays (constitutional and oncology) and transitioning them into the clinical environment by developing the SOPs and training the CLSs to perform the assays; reported directly to the Departmental DirectorDuties included but were not limited to the following:• Was a part of a team responsible for designing experiments that would allow us to evaluate and validate new assays, equipment and reagents• Was responsible for interacting directly with vendors that serviced the department’s needs• Was responsible for developing, validating and transitioning all departmental assays into the clinical environment• Was responsible for departmental SOP development and implementation• Was part of a team that interacted directly with the Bioinformatics department to ensure that all departmental needs were acknowledged and addressed• Was responsible for traveling to professional conferences and reporting trends and potential new assay development back to upper management• Was a part of a team responsible for new assay development• Was responsible for troubleshooting any problems reported by the clinical team as they related to any assays already transitioned into the clinical environment Show less