Vicki Pounder Email & Phone Number

Cambridge, Ma, Us

Framingham, Massachusetts, United States

Cambridge, Massachusetts, United States

Supervised the manufacturing team (GMP) in daily operations and complex Next Generation Sequencing assays.Strategically analyzed problems using strong critical and logical thinking. Drove troubleshooting activities to minimize product, equipment, or operational issues.Collaborated with cross-functional groups, including QA, PD, and R+D, on critical technical manufacturing projects and operational initiatives to define the design, operation, and strategy as the primary manufacturing representative.Assisted with technology transfer between teams.Drove multiple FMEA focus groups for developing or improving processes.Analyzed QC metric failures within the laboratory to determine root cause analysis.Designed and executed Process Development tasks for cost reduction and time efficiency.Oversaw consumable inventory and equipment maintenance and calibration to maintain quality control and compliance with the Laboratory Assistant, Facilities, and Logistics departments.Initiated and completed reports, IQ, OQ, and PQ for the new site set up and sample processing readiness.Executed nucleic acid extractions and next-generation sequencing based cancer genomics workflows including exome and transcriptome sequencing in a cGMP environment.Established new automated methods of nucleic acid extraction for blood and tissue tumor samples.Tested automated methods for higher throughput processing from manual techniques.Created and implemented new quality documents and reviewed and revised those in-process.Authored new SOP’s, forms, CAPA’s, and deviations.Developed and implemented Electronic Batch Records within Master Control for GMP laboratory use.Performed manufacturing reviews and sign off on Electronic Batch Records and all other QA/QC forms.Conducted QC testing and approval on specific critical reagents.Trained junior associates and new managers in company policies, assays, and troubleshooting.Coordinated and scheduled activities of other team members.

Cambridge, Massachusetts

Cambridge, Ma

Performed sample receipt and accessioning Performed DNA extraction from Whole Blood specimens manually with Qiagen kitQuantified DNA using a Tecan and a DropSense plate readerBuilt assays in CoreLIMS and custom LIMS programPerformed Genotyping assays by SNaPshotPerformed Southern Blot assays including dark room x-ray film developingPerformed Next Generation Sequencing assays using Illumina HiSeq robots and Tecans utilizing 8-Span and 96-Head Liquid Handling PlatformsPerformed Sanger sequencing assays using Ampure and CleanSeq purification methods Resulted Genotyping assays on Gene Mapper software with sequencing data from 3730 robotsReviewed and submitted results for Illumina HiSeq runsReviewed and submitted results for Southern Blot assaysEntered results for all known assays into custom LIMS programTrained other technologists on Genotyping, Southern Blots, and Next Generation Sequencing assay stepsPerformed daily and weekly maintenance on Tecan robotsPerformed daily maintenance on ABI 3730 machinesPerformed pre and post run maintenance washes on Illumina HiSeq robotsReviewed and revised SOPs and working documents as neededParticipated in lab safety meetings quarterly with QC department

Waltham, Ma

Performed DNA extraction from Whole Blood specimens using manual techniques and a Qiagen QIAcube robot. Performed DNA extraction from Buccal Swab samples, Saliva Samples, and Frozen Cell Lines using manual techniques.Reviewed and Revised SOPs as needed.Performed duties in compliance with company SOPs and Health and Safety regulations. Performed daily, weekly, monthly, and yearly Quality Control checks on lab equipment and documentation. Scheduled preventative maintenance and services on lab equipment. Ordered and received lab supplies as needed and entered data into excel spreadsheets and Peoplesoft online ordering system.Performed sample receipt and accessioning using great attention to detail to match specimen information to documents and interpret many different kinds of requisition forms.Quantified DNA specimens after extraction using a Nanodrop Spectrophotometer and eluted to desired concentration.Performed PCR setup using Protedyne Radius Robot.Performed PCR cleanup using Ampure manual technique.Performed Sequencing setup using manual technique.Performed Sequence cleanup using CleanSeq and exosapIT manual techniques.

Worcester, Ma

Performed DNA extraction from Whole Blood specimens and frozen cell lines using manual techniques, a Gentra Autopure robot and a Roche MagnaPure Robot.Performed duties in compliance with company SOPs, GLPs and Health and Safety regulations.Built DNA result projects and pre-screened data prior to DNA analysis using SeqScape with sequencing data from 3730 robots.

Bedford, Ma

Performed biocompatibility tests including, but not limited to, Cytotoxicity, Sensitization, Irritation and Intracutaneous Reactivity Tests, Systemic Tests (Acute), Toxicity Tests (Sub-acute to Chronic), Explanting Implantation Tests, USP Class VI Tests, Immunotoxicity and Dermals. Performed studies in compliance with Sponsor protocols, company SOPs, and GLPs. Performed studies under ISO and USP guidelines accordingly. Handled animals including mice, rats, hamsters, guinea pigs, rabbits, dogs, pigs.Mouse and rat IP and IV injections, rat oral limit dosing, hamster buccals (cheek pouch dosing), guinea pig Kligman sensitization intradermal and dermal dosing, rabbit intracutaneous and dermal dosing, full rat necropsies, mouse necropsies, rabbit necropsies, rabbit dorsal muscle implants using a trochar, pain medication administering, rabbit pyrogen testing including ear vein dosing and rectal temperature readings, rabbit marginal ear vein bleeding, test material preparation, animal clinical observations, bone marrow extraction from mouse femur.