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Manufacturing Quality

Location:
San Jose, California, United States
Posted:
June 12, 2019

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Resume:

Phu Pham

San Jose, CA ***** 408-***-****

ac9lgl@r.postjobfree.com https://www.linkedin.com/in/phu-pham-237aab10/

Research Associate / Manufacturing Associate

Contribute Expertise, Skills, Passion, and Success to the Company’s Core Values

Self-motivated, enthusiastic professional determined to get job done well and on time. Detailed-oriented, disciplined, and focused, collaborating effectively at levels across cross-functional departments and within complex team and matrixed organizational structures.

Skills

Certification:

Biotechnology Certificate Program at UCSC extension, Santa Clara, CA, GMP, GLP, GDP, ISO17025 manufacturing environments

Computer:

Windows Operating Systems: Windows 7 & 10

Applications:

MS Word, Excel, PowerPoint, Access, Oracle Database, SAP, EDMS, Oracle E-Business Suite, Epicor Software, ServiceNow, Spotfire, Global Software Query Exchange, LIMS, and Heat Map

Equipment:

Covaris, Kingfisher Purification/Size-Selection, Thermocycler, LabChip GX, Touch Caliper, BMG Omega Microplate Reader, Hamilton Automation, Tecan Automation, Alpha Imager, Peristaltic Pumps, Plate Sealers, Pipeline Dispenser, pH Conductivity, Refractive Index, Seven Excellence, SE S470K pH meter, XP504 balance using Lab X, Nanodrop

Technical:

PCR, Sequencing, DNA quantitation, DNA extraction, DNA Fragmentation/Size-Selection, DNA/Protein, Purification, DNA shearing, Gel Electrophoresis, Chromatography, Spectrophotometry, ELISA, Cell Culture, FACS, Buffer Prep, enzyme handling, automated liquid handling (Hamilton and Tecan)

Experience

COMPLETE GENOMICS INC., San Jose, CA 2017 - 2019

MA IV, Reagent Department

Performed quality control and passed new lot reagents using sequencing instruments before releasing for researchers to use. Provided high-quality highly available standard reagents and special request reagents. Knowledgeable in Lean Manufacturing: 5S, Operational Excellence, Kaizen, Kanban Replenishment Systems. Supported research department with in-house reagents for different platforms of sequencing instruments. Weekly reagent inventory and restock lab supplies.

Participated in antibody project experiments, obtaining better Ab clones, developing Ab kit production, QC antibody binding buffer, testing and comparing different Ab clones to select the best for use.

Presented experiment data analysis and QC results in Antibody & Biochemistry group meetings, providing update on the projects.

COMPLETE GENOMICS INC., Mountain View, CA 2010 - 2017

MA III, Reagent Department

Formulated and QC sequencing reagents and library reagents. Manufactured Reagent Specifications and Raw Material Specifications, completed document reviews and revisions. Maintained management of production metrics, safety corrective actions, and daily 5S audits / improvements. Fulfilled reagent requests, placed purchase orders, handled material and inventory management.

Validated and executed Performance of Qualifications (PQ) CPL plate automation for Denali projects on Hamilton, qualifying installation and operation of the CPL plate script for the purpose of filling CPL plates using Hamilton’s STARLET robotic liquid handling system.

Phu Pham ac9lgl@r.postjobfree.com Page Two

COMPLETE GENOMICS INC. (Continued)

Performed reagent manufacturing processes in compliance with ISO17025 regulatory requirements and the company’s Quality Management System.

Led daily production processes with >80% of time allocated to direct labor. Extensive knowledge required for ISO Quality Systems, including Calibration / Preventative Maintenance (PM), Non-Conformance Report (NCR), and Corrective & Preventative Action (CAPA).

Produced and delivered manufactured reagents and raw materials, supporting high throughput whole human genome sequencing operation and R&D.

Managed Kanban replenishment systems for Sequencing and Library Preparation reagents, maximizing inventory availability, minimize scrapping, and eliminate stock-outs.

Participated in weekly inventory cycle counts and quarterly physical inventory counts, sustaining inventory accuracy of >95%.

Biologist, Production / Sequencing 2010 - 2013

Operated, troubleshot, and maintained DNA sequencers and Tecan liquid handler for genome loading. Demonstrated knowledge in use of Spotfire for data analysis, Epicor, & LIMS system.

Communicated laboratory issues and updates to the group and respective departments in a timely manner.

Loaded DNB for customer genomes, slide request, and standard slides, supporting different departments i.e. Reagent QC, Flow-slide Manufacturing and Process development.

Lab Support Technician, Complete Genomics, Production 2010

Managed inventories of lab reagents and consumable, including ordering of materials. Stocked materials in multiple production labs. Oversaw inventories of lab reagents and consumable materials, including ordering of materials and lab equipment maintenance including, pipette calibration program, periodic maintenance of TECAN & rapid plate, water baths, and freezer defrosting program.

PDL BIOPHARMA / FACET BIOTECH CORPORATION, Redwood City, CA 2007 - 2009

Research Associate

Handled Research Centralized Cell Bank: acquire, preserve, and distribute wide variety of cell lines. Performed cell transfections of 293s cell lines using Amaxa Electroporation Nucleofector and daily cell requests, inventory and restocking of cell bank. Monitored and maintained ultra-cold freezers, storage tanks, refrigerators, freezers, and incubators. Updated Calypso database and master cryo-storage log with new cell lines.

Froze cell lines using DMSO solutions and rate-controlled freezers to restock cell banking.

Sent out cell samples for Infectious Microbe PCR Amplification Test (IMPACT) to detect wide range of known contaminants when needed and upon request by researchers and notified researchers once receiving results from RADIL.

Education

Bachelor of Science (BS), Computer Science, San Jose State University, San Jose, CA

Biotechnology Certificate Program, UCSC extension, Santa Clara, CA



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