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Yizhu Chen

******@*****.***

**** ****** ****

Gaithersburg, MD 20878

240-***-****(M)

SUMMARY Organized and detail-oriented, self-motivated, result-orientated and technical expertise individual with professional experiences in cGMP Manufacturing Purification within the biotech industry. Possess well developed communication skills, committed to excellence.

SKILLS AND QUALIFICATION

Aseptic technique – understand the basic operation of biological safety cabinet

Pipetting skill – experience with various types of pipetting tools include manual and automated pipett

Nuclei Acid methods – familiar with various nucleic acids methods use in the lab, include DNA gel electrophoresis, DNA quantitation, PCR, DNA purification and RNA isolation

GMP documentation practice

Qumas (E-Document Compliance)/ FDA approved

Plateau Learning Program (MyLearning)/ FDA approved

QLIMS (Quality Control Computer-based program)/FDA approved

Proficient at using general laboratory equipments

Work well as team member or independently.

Detailed oriented

Computer proficient: Word, Outlook, Excel, PowerPoint

Fluent in English, Mandarin Chinese, and Fujian dialect

WORK EXPERIENCE

Macrogenics, Downstream Manufacturing Associate I

Rockville, MD (04/2016 – 11/2017)

Set up and execution of buffer preparation per batch document instructions

Set up and execution of column chromatography with AKTAready Unicorn software per SOP and BR instructed

UFDF tangential flow filtration, hollow fiber membrane and formulation

cGMP manufacturing using single use and disposable technologies.

Register and transfer daily in-process samples with LIMS

Document all manufacturing activities in compliance with FDA standards

Column packing and qualification during product change over

Work with various hazardous materials under standard operating procedures

Support various change over activities

Draft and editing of SOPs and Batch Records

Maintenance and organization of supply inventory

Place purchase order for raw materials and obtain raw materials specification from vendors

GlaxoSmithKline, Downstream Manufacturing Associate I

Rockville, MD (02/2015 – 02/2016)

Knowledge and understanding of Downstream Manufacturing process operations

Set up and execution of chromatography skid and the Unicorn skid methods

Execution of UFDF included final formulation

Execution of column packing procedures in order to support the change over

Perform CIP and SIP of product tanks

Improve process flow with SOPs and BRs revision

Utilized Solo VPE for measuring the protein concentration of in process samples

QLIM in process sample submission process includes label printing, receiving and locating of sample.

Operation of Bioprocess equipment under strict adherence to and enforce cGMP, OSHA and policies and regulations, and other as required.

Completing daily manufacturing tasks per standard operating procedures and batch document instructions

Monitors critical process parameters

Documenting all manufacturing activities clearly and accurately in logbooks and batch records

Ensures all processing equipment and materials necessary are adequate and available to set the team up for success

Ensures all production activities are completed in a safe and compliant manner

Maintain and prepare high quality documentation

Work with hazardous materials under the appropriate safety procedures

Performs other functions as necessary or as assigned

Walter Reed Medical Center, Radiology Department

Bethesda, MD (02/2012 – 06/2012)

Responsible for the preparation of X-ray room prior to patient arrival

Prepare patients for the procedure, record images and then prepare a report for doctors to review

Follow physician’s orders regarding the areas of the body of which they need images

Explain procedures to patients and follow procedures that prevent unnecessary exposure to the patients

Develop x-ray films and adjust and maintain x-ray equipments

Maintain safe and clean working environment by complying with procedures, rules, and regulations

Provide safe and effective care to the patients in the radiology department

George Washington University Hospital, Radiology Department

Washington D.C. (07/2012 – 09/2012)

Applying learned imaging technique to deliver quality care for the patients

Responsible for the care of the patients in the radiology department

Prepare patient for radiological procedure by positioning patient; adjusting immobilization devices; moving equipment into specified position; adjusting equipment controls to set exposure factors.

Maintain production and quality of radiographs by following established standards and procedures; developing radiographs; observing radiographic results; making necessary adjustments

Work alone side doctors for the various radiology procedures that are need outside of radiology department

Taipei Tokyo Restaurant, Part-time Cashier/Manager

Rockville, MD (01/2013 – 02/15)

Identify and estimate quantities of foods, beverages, and supplies to be ordered.

Maintain relationships with customers and staff and resolve customer complaints about food quality or service

Monitor actions of staff and customers to ensure that health and safety standards and liquor regulations are obeyed

Use computer software to monitor inventory, track/create staff schedules, and perform other record keeping tasks

Arrange for maintenance and repair of equipment and other services

Recruit, hire, and oversee training for staff.

EDUCATION B.S, Biotechnology, degree in progress,

University of Maryland University College, (UMUC)

Relevant Course Work

Chemistry

Principles of Biology

General Genetic

Microbiology

Cell Culture and Cell Function

Protein Biotechnology

Nuclei Acid Methods

References

Gerry Navarette

GlaxoSmithKline, Downstream Supervisor

Cellphone: 240-***-****

Contact this candidate