Huiting Wang

*** ********** **. ******** ** ***** Cell: 650-***-**** e-mail: ad19br@r.postjobfree.com

OBJECTIVES

Looking for a senior position in the Bio-tech industry.

PROFESSIONAL SKILLS

●Over 25 years of working experiences in bio-tech Industry

●Hands on with HPLC, IC methods and instruments trouble shootings (HP/Agilent, Waters and Dionex), ELISA, SDS-PAGE, Protein Purification Techniques (AKTA).

●Method validation experiences in QC/QA in environment in Bio-tech industry.

●Performed Peptide Mapping, Carbohydrate testing with the FDA-approved products.

●Reviewed the testing records in the QC lab for the release of products including small and large molecules.

●Expert in QC investigation for OOS testing. Expert in QC area with FDA inspections from USA, Europe and Asia. Experts in EXCEL JMP, Empower 2. LIMS. Familiar with Trackwise, electronic document management system, SAP in Quality unit. Provided trend analysis in different testing.

●Worked as interpreter and translator as volunteer for Bayer Submission in Mainland China for product approval.

●Good in managing time with different projects at the same time.

●Detail-oriented, self-motivated analytical scientist, strong team player.

PROFESSIONAL EXPERIENCES

Oct. 2019 - June 2023

Senior Process Development Associate in CMC at NGM Biopharmaceuticals

Working independently in the lab during the pandemic time period.

Assistant for the setup of PA- 8000 Plus from AB SCIEX in house. Learned the new CE tech. for the IgG purity method and the 32 Karat software. Performed both the Non-reduced and Reduced CE-SDS by using the CESI/ PA-8000 Plus on the NGM-621,282 and 707 DS,DP and stability lots.

Set up the Waters HPLC system in the CMC Lab. Attended the seminars and Empower training.

Learned and performed the c-IEF on the Maurice by the Capillary isoelectric focusing for the NGM395 DS.

Supporting the NGM 282 methods study in DS and DP final formulation samples.

Trouble shooting with the HPLC system and the SAX columns from Agilent.

Participating the Reverse phase ultra-HPLC (RP-UHPLC), Strong Anion Exchange (SAX-HPLC), Size Exclusion Chromatography (SEC) analytical procedures study.

Learned the software of OpenLab 2.6 and ChemStation for the Agilent HPLC system.

Learned and use the ELN for the data records. Practiced in the daily lab work.

Learned and troubleshooting the instrument for the HPLC systems. (Agilent 1260,1290)

Worked as a coordinator with the service personnel from Agilent to repair and set up the new HPLC system 1260 Infinity in the CMC lab.

Managing the samples shipment to Lonza in CMC lab. Keep the receiving samples at the right temperature and distribute to other labs for the analysis.

Trained new contractors for the HPLC systems and lab routine work.

2015-2018 Personnel consulting for startup Biotech and China Food & Drug Admin. (CFDA).

Editing the translations in Chinese and English. Reviewed the Data records for the CFDA submission. Reviewed the validation reports for the sialic acids, peptide mapping analysis.

2014. Analytical Chemistry Analyst at Genentech, Method Management & Technology, Contracting via PRO-Unlimited

●Methods troubleshooting and validation, Sialic Acid and Total Neutral Sugar Analysis.

●Perform testing to setup specification of new methods.

●QC/QA review for the analytical validation and transfer.

●Manage samples to support method validations

1994-2011, Bayer corp. Berkeley CA.

2003-2011, Sr. QC Analyst, QC Carbohydrate Chemistry, Bayer corp., Berkeley CA

Performed all QC Carbohydrate testing: including NANA, NASA, Capping, Oligosaccharides testing and Peptide mapping. Support all the validation work in different assays for FDA inspections. Participated all the methods transfer plans between Labs within QC on-site and between two sites. Such as between Emeryville and Berkeley QC methods transfer. Seattle and Berkeley Bayer between two labs QC methods transfer. Supported all the software and instruments update testing such as IQ/PQ in all Carbohydrate assays. Expert in validation testing and OOS investigation trouble shooting in the QC area.

Trained newly hire and current employees in the QC labs for all the Carbohydrate area testing. Trouble shooting with instruments such as HP(Agilent 1200), Waters, Dionex 500/ 600 and etc.)

Reviewed the validation report data for the methods transfers. Performed all routine compliance review on the reagent log books, instrument logbooks in QC area. Acting as supervisor when the manager was out of the site.

1994 -2003, Associate Research Scientist, Process Science, Bayer Pharmaceuticals. Berkeley CA

Responsible for the validation testing in Protein and Carbohydrates. Supported the submission for FDA approve for the rFVIII-FS in US and Europe.

Wrote and updated all the SOP’s for different assays. Participated all the validation activities. Including validation protocols, different testing on C/D (concentration/desalting), NANA (sialic acid), NASA (Monosaccharides), Capping, alpha- Gal and total Protein assays. Supported all the assays transfer from Validation to QC labs for the routine testing. Trained new hire employees for the daily testing. Reviewed the routine data results in QC area for other operators. Participated most CAPA in QA area. Trouble shooting with instruments for daily operation in the lab.

Assisted for Bayer employees part time in the Regulatory Affairs Department. Worked as translator and reviewer for the submission of approve license by selling products of Bayer in Mainland China through CFDA. Received the Special Recognized Award from the validation work for alpha- Galactose and Capping testing.

1989- 1994, Chemist in QA Chemistry Lab. Cutter/ Miles Corp. Berkeley CA

Major responsibility including Calibrated all the instruments (PH Meters, conductivity meters and spectrophotometers) routinely inside the QA lab and manufacture area. Performed different testing on the raw material and the final products. Participated in the safety team for the lab auditing in the QC area.

Experts in the HPLC, FPLC, Spectrophotometer and FTIR testing. Performed all the QA stability testing in the chemistry lab, such as amino acid testing and Blood Bags stability. Wrote and revised different SOP’s for the chemistry labs routine testing. Maintain the HPLC systems for routinely operation.

EDUCATION

M.S. in Analytical Chemistry. East Tennessee State University.

B.S. in Pharmacy. Beijing Chinese Medical College.

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