Engineer Process

YU ZHANG

*** ********* ****, **** ***, Chelmsford, ma 01824

Cell phone: 508-***-****

E-mail: **********@*****.***

SUMMARY OF QUALIFICATIONS

12+ years Bioprocess experiences in downstream processing of biologics, including scale-up and scale-down, from tech transfer to commercial scale.

Sound knowledge and experiences in cell culture and fermentation, centrifugation, precipitation, UF/DF (Ultra filtration /diafiltration), protein A, cation and anion exchange chromatography, hydrophobic interaction chromatography (HIC), sterile filtration, viral retention filtration.

Familiar with CHO, Vero cell, DC44, E. Coli and other cell culture.

Project management experiences in budgeting, CMO management, equipment validation, process characterization study, user specification analysis, draft of biologic release qualification.

Organize cross-function team to resolve project related issues such as raw material evaluation, CMO facility validation and process related studies.

Draft evaluate process tech transfer documents, SOPs, process characterization summary report to define KPPs (Key process parameter) and CPP (Critical process parameters).

Utilize Delta V, Statistica, PI Processbook, LIMS, EDMQ, Data Lake, Trackwise and other so for process monitoring data retrieval and analysis.

Utilize statistic software such as Pi Processbook, JUMP, statistica, SIMCA P+, LIMS, Trackwise for process monitoring data retrieval, analysis deviation investigation, and change control implementation.

Assay development and application for purification projects, including icIEF, plaque assay (for virus); fluorescent protein A quantification, HCP ELISA, Picogreen, Q-PCR for DNA quantification, SEC-HPLC, UPLC, endonuclease ELISA assay, FT-IR, Utilize AKTA ready system with Unicorn software, low flow kit, Biocad, TECAN robotic system, GPC, UV-Vis spectrometer.

EDUCATION

Graduate study in Biotech Engineering, Tufts University Jan 2007- Jan 2009

Honors B.Sc. in Biopharmaceutical Science Jul. 2002-April 2006

University of Ottawa, Ottawa, Canada

PROFESSIONAL EXPERIENCE

Sr. Engineer,

Amgen Inc.

External Manufacturing Group, Process Development Oct. 2017- Current

Responsible for tech transfer for Imlygic, the first cancer viral modality that recently gained FDA approval, including: Raw material evaluation, buffer quantity calculation, and BOM (bill of material) creation and modification, Equipment evaluation and ordering of new equipments, equipment software modification (such as AKTA ready skid method modification, UF/DF skid method modification), PTD (process technical transfer document) generation, process SOP generation, review and approval; process characterization and operation study review and approval; GAP analysis, facility, equipment, and process risk assessment, etc.

Software used: EDMQ, DATA lake, PI processbook, etc.

Bioprocess Engineer/ Scientist II, MSAT downstream

Lonza Biologics, Inc. Portsmouth NH Nov.2014- Oct. 2017

Responsible for the MSAT (Manufacturing Science and Technology)phase of allocated Customer projects

Apply Delta V, Statistica, Trackwise, LIMS, Procesbook and other software to track data and conduct data analysis.

Perform pre and post Pilot Plant activities for Customer Projects including CAPA, change control, planned deviations in a timely manner according to the agreed project schedule.

Take lead in product tech transfer activities, including Gap analysis, scale-up process model design and generation, process control modifications.

Draft, review and approve process description, formulation descriptions, batch records, downstream processing SOPs, product specifications, campaign summary reports and other deliverables for internal MSAT and customers. SOPs include column packing, protein A, anion and cation exchange chromatography operation, Planova Viral retention filtration and UF/DF.

Troubleshoot process related deviations, communicate closely with project manager, manufacturing, external QA, MSAT representative to evaluate product quality impact, yield, out of specification assay results and other related issues. Write memo for process related deviations, stability, yield, release study, evaluate process characterization study

Bioprocess Engineer Scientist I, Global Supply,

Pfizer, Andover, MA Jan2012- Nov. 2014

Purify large scale biologics that are critical for patient health and well-beings.

Utilizing centrifugation, ultrafiltration, protein A and ion exchange chromatography, virus retention filtration and TFF and other purification tools in design and optimize downstream purification processes. Design experiments and optimize processes, provide solutions to process related issues, such as yield loss, and product quality variations. Trouble-shoot equipment, operation system related discrepancies that may impact product quality, productivity, yield and other critical parameters.

Involved in small and large scale biologic upstream manufacturing processes, from seed lab, shake flask up to 12000L bioreactors. Monitor process related parameters such as dissolved oxygen, glucose level, etc. Identify process related deviations and take immediate actions.

Provide answer and solutions to FDA and other regulatory bodies, make sure the manufacturing batch records are precise, current and free-of error by co-review with QA as well as other manufacturing colleagues.

Active lead and participate in continuous process improvements by M1, M2, 5S and other project targets.

Utilize SIMCA P+, MCS, iHistorian, Kanban and other online monitoring and statistic tools for manufacturing control and data analysis, provide root-cause analysis for out-of-limit batches and scenarios.

Development Engineer Scientist II

R & D, Bioprocess Division, EMD Millipore May 2006-Jan. 2012

Develop innovative products and downstream purification processes for CHO / yeast / E. coli cell culture, utilizing purification techniques such as centrifugation, clarification, depth filtration, protein A and ion exchange chromatography, ultra filtration, TFF, virus filtration, etc. Played key role in the following projects: 1) Membrane Adsorber, disposable anion exchanger chromatography media, test and optimize the performance of the membrane adsorber, apply the membrane device in disposable process for customers. 2) Develop all-disposable process for Mab purification process up to 2000L scale. Evaluate flocculation reagents, such as smart polymer anion exchange polymer for clarification, utilize millistak + XOHC, DOHC and other filtration media in the single-use monoclonal antibody purification process to meet the specific single use applications for customers. 3) Participate in the High capacity protein A affinity Chromatography resin development. (Prosep Ultra Plus). Apply IgG Dynamic binding capacity test, HCP ELISA, protein A ELISA, picogreen test SDS-PAGE and other methods in testing the performance of the media. Key member in developing fluorescence protein A leakage assay.

Chemical Engineer (Intern) May 2005-Jan. 2006

Rohm and Haas Electronic Material Co. Ltd, Marlboro, MA, USA

Applying applied physics, chemistry and engineering methods to design, formulate and modify lithographic materials.

Monitoring acid diffusion in photo resist matrices via fluorescence spectroscopy.

Gaining experience in absorption spectroscopy, spin coating, using volumetric equipment, photo resist chemistry, acid-base equilibrium, and diffusion theory.

Getting trained on state of the art lithographic tools such as ASML/800 Scanner, TEL MARK8 Track, KLA8100 SEM to test resist prototypes.

Analytical Chemist (Intern) Jan/2004-Sept./2004

Maxxam Analytics Inc., Mississauga, ON, Canada

Applied, validated and transferred methods for analysis of water, beverage and other environmental samples for various testings as per client or GMP requirements utilizing GC, HPLC and other instruments.

Quality Control Chemist (Intern) May/2003-Aug/2003

Novopharm Co. Ltd, Markham, ON, Canada

Conducted analytical tests of raw materials, in-process products, finished products and stability testing under GMP requirements.

Performed various tests using UV/Vis, HPLC, GC and etc.

Patents and patent applications:

Grafting method to improve chromatography media performance, WO 201-***-****

Methods for purifying a target protein from one or more impurities in a sample. US.2011/0065901A1

Stimulus Responsive Polymers for the Purification of Biomolecules, US.2011/0313066A1

Presentaitons:

Chromatographic Three step antibody purification with no intermediate tank, IBC Antibody Production and Development, Carlsbad, CA 2010

Development of new ion exchange chromatography media for antibody processing: Improvement in processing flexibility and economics ACS BIOT conference in Washington DC, 2009

Award- Pfizer Mission Award

Utilizing Transition Analysis in evaluating chromatography Column Performance

Award- Lonza Recognition Award

For upstream and downstream cross-function investigation on filter clogging

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