Lean Six Project

SIXI WANG

Newark, DE • C: 626-***-**** • *********@*******.*** Visa Status: Green Card

PROFESSIONAL SUMMARY

Production Supervisor:

Implemented lean and six sigma methodology to reduce cost and to improve products’ quality and consistency. Developed and implemented quality control steps into manufacturing process, improved production yield from 50% up to 90%. Optimized clean-in-place process and reduced production cycle time from 10 days to 7 days. Designed and managed the scale-up project which scaled up batch size from lab scale to pilot scale. Facilitates operational approach to ensure production goals are met on a daily basis. Established and maintained the lab hygiene plan, hazard waste collection and disposal standards, and safety training processes. R&D Project Leader:

Designed, developed and launched a new polymer based HPLC resin product line. Established SOPs, quality control system, safety guild lines and applications of the new product line. Led the project of transferring the new technology to manufacturing team. Monitored and consulted scale-up project from lab scale to pilot scale. Research Biochemist:

Worked with customs to develop protein analytical method on HPLC. Designed experiments, developed application notes and published data on posters at conferences. CORE QUALIFICATIONS

Manufacturing management Project planning, development & management Hazard material handling expertise New product development, launch & orientation New process development & validation Manufacturing process continuous improvement engineering Root cause analysis & troubleshooting Design of Experiment & Quality by Design Knowledge of GMP & cGMP Industrial scale up experience Multiple teams collaboration Statistical process control OSHA, EPA & DOT regulations Lean Six Sigma manufacturing design and development, Minitab data analysis Quality assurance training (ISO-9001, CAPA)

WORK HISTORY

Production Supervisor

Expertise in HPLC, UPLC, FPLC, FT-IR, UV/VIS

Sepax Technologies, Inc - Newark, DE 06/2015 - Current

• Designed and managed multiple continuous improvement projects of manufacturing process by applying lean manufacturing and six sigma principles, such as reducing cost of raw material, waste generation, and improving quality and consistency.

• Improved production yield from 50% up to 90% by developing quality control steps into manufacturing process.

• Implemented lean methodology to optimize clean-in-place process and reduced production cycle time from 10 days to 7 days.

• Developed and managed resin production scale-up project (lab scale to pilot scale), designed & developed new equipment.

• Plan & monitor daily HPLC resin production, directed & coordinated manpower to meet aggressive production schedules.

• Established and maintain a raw material control system including control methods and specifications.

• Use statistical techniques including Design of Experiments, Evaluating the Measurement Procedure, and Statistical Process Control to improve working efficiency (Yield & Output).

• Advise management and operations staff on necessary adjustments and changes to protocols to minimize future incidents.

• Take responsibility for driving the root cause investigation and the implementation of corrective action for unplanned events.

• Review and analyze operations data to evaluate and recommend changes for efficient and continuous operation.

• Review, modify, validate & update SOPs.

• Coordinate with quality assurance team for internal and external ISO 9001 audit.

• Provide training and coaching to other technical and manufacturing associates.

• Manage and maintain all documents, such as training log, SOP, SDS, COA.

• Established and maintain the lab hygiene plan, hazard waste collection and disposal standards, and safety training processes. R&D Project Leader

Sepax Technologies, Inc. - Newark, DE 01/2013 - 05/2015

• Developed and launched a new polymer based HPLC product line including ion exchange and hydrophobic interaction resins

(Polar MC & Generick MC), which are used in separation of bio-molecules and industrial process purification.

• Established experiments as biochemist and chemist with Quality by Design and Design of Experiment methodology.

• Established project objectives, experiments, policies, SOP with boundaries of company policy.

• Communicated clearly and efficiently with team members and management on project status and progress towards milestone.

• Transferred the new technology to manufacturing team and provided technical support.

• Monitored the manufacturing process for optimization of scaling up to pilot scale.

• Coordinated with application team to develop application project for new products for marketing team.

• Oversaw the production process and managed the production schedule. Research Biochemist

Sepax Technologies, Inc. - Newark, DE 06/2012 – 12/2012

• Involved in HPLC resin & column method development.

• Conducted experiments in laboratory (Inorganic & organic chemistry).

• Coordinated with application team to help customers develop analytical method to identify their samples.

• Conducted routine tests to release HPLC column products as quality control person. CERTIFICATIONS & PUBLICATIONS

Lean Six Sigma Green Belt Certificate

Hazardous Chemical Inventory & Tier II Manager Certificate

DOT Hazardous Waste Manifest Certificate

Management Training

S. Wang*, J. Tiongson and M. E. Rasche. Discovery and Characterization of the First Archaeal Dihydromethanopterin Reductase, an Iron-Sulfur Flavoprotein from Methanosarcina mazei. J. Bacteriol. January 2014 vol. 196 no. 2 203-209

EDUCATION

Master of Science in Biochemistry, May 2012, California State University Fullerton, Fullerton, CA Thesis: Discovery and Characterization of the First Archaeal Dihydromethanopterin Reductase (DmrX), an Iron Sulfur Flavoprotein from Methanosacina mazei

Bachelor of Science in Applied Chemistry, July 2007, Beijing University of Technology, Beijing, China ADDITIONAL EXPERIENCE

• Preparative and Process Chromatography – PREP 2017: Poster

• Preparative and Process Chromatography – PREP 2015: Poster (Lead author)

• Separation and Characterization of Biologically Important Molecules – ISPPP 2015: Poster (Lead author)

• Protein and Antibody Engineering Summit – PEGS 2015: Poster (Lead author)

• Protein and Antibody Engineering Summit – PEGS 2013: Poster (Lead author)

• 2013 Pittcon Conference & Expo: Poster (Lead author)

• 2012 Gordon Research Conference: Molecular Basis of Microbial One-Carbon Metabolism, Gordon-Kenan Research Poster presentation: Discovery and Characterization of the First Archaeal DihydromethanopterinReductase (DmrX), an Iron-Sulfur Flavoprotein from Methanosarcina mazei

• 24th Annual CSU Biotechnology Symposium: Poster presentation

• Research Assistant for Characterization of Fe-S cluster Flavoprotein in Methanosarcina mazei and enzyme assay development

• Teaching Assistant for General Biochemistry class

• 26th Annual CSU Student Research Competition

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