Reagent Manager

STEPHANIE HAN

*** ******** ******, **** ****, CA 94015

Phone: 415-***-**** Email: **************@*****.***

PROFESSIONAL SUMMARY:

Highly motivated, disciplined, and focused professional with years of lab experience. Adaptable personality with an ability to work in any environment and under pressure. Enthusiastic and dedicated self-starter with strong problem-solving skills and a desire to learn new concepts.

AREAS OF EXPERTISE:

Proficient immunology experience in mass cytometry (CyTOF).

Extensive hands-on experience in flow cytometry various stimulations and staining methods.

Expert in Cytobank data analysis.

Cell and tissue culturing.

Extraction of PBMCs, mouse splenocytes, mouse bone marrow, DNA, and RNA.

Metal-Antibody conjugation with various scales, ranging from 100ug to 3000ug.

bDNA chemiluminescence assay and protein purification.

Strong researching, analyzing, inventory budgeting, and management skills.

LAB SKILLS:

Flow Cytometry: Barcoding, surface staining, cytoplasmic staining, phospho staining, TH2 & TH17 polarization, various stimulations, and deriving dendritic cells from frozen human PBMCs and mouse bone marrow.

Conjugation: Metal-polymer antibody conjugation, oligo/protein - magnetic bead conjugation, alkaline phosphatase - DNA conjugation.

Molecular Biology Techniques: Molecular cloning, plasmid purification, PCR amplification, protein expression, protein purification, DNA/RNA purification, transfection, and nuclear extractions.

Assay: Gel shift assay, ELISA assay, oligoes/antibodies/proteins array assay, bDNA luminescent assay, bDNA Multiplex bead assay, FFPE RNA/cell culture RNA in situ hybridization assay, and western blot.

Gel electrophoresis: SDS polyacrylamide gel, native polyacrylamide gel, and agarose gel.

ACCOMPLISHMENTS:

Received “Exceeds Expectations” or “Outstanding” annual review ratings for the past eight years.

Successfully launched and transferred 600+ catalog items to production.

Planned and executed manufacturing process to ensure products were delivered on time and under budget while maintaining high quality standard of products.

Managed, manufactured, and maintained 700+ products.

EXPERIENCE:

Scientist/Reagent Manager – Fluidigm, South San Francisco (December 2014 – May 2019)

Oversaw and managed production team’s day-to-day responsibilities.

Designed, planned, and executed experiments (20-30 antibodies/panel) for daily CyTOF performance.

Preparing samples from PBMCs, whole blood, cell/tissue culture, and mouse tissue.

Run and maintenance lab instruments.

Analyzed data using Cytobank/FlowJo and put them in PowerPoint for record/presentation.

Designed and executed troubleshooting experiments for projects related to customer complaints, inputs, and feedbacks.

Worked very closely with pharmaceutical and academic customers on custom conjugation service.

Coordinated with R&D, Purchasing, Quality Assurance, Marketing, Sales Administrator, and Logistics to deliver quality products.

Wrote and implemented SOP and MBR (Manufacture Batch Record) and built BOM (Bill of Material) for new products.

Maintained year-end inventory discrepancy of less than 0.2% for every year (duration of eight years).

Involved in the process of receiving ISO 13485:2003 and ISO 9001:2008 certification.

Developed and implemented 5S in manufacturing lab.

Compiled CAPA or nonconformance documentation assigned corrective and preventive actions.

Prepared documents for ISO audits.

Research Scientist – DVS Sciences, Acquired by Fluidigm (July 2011 – December 2014)

Successfully launched 600+ products (metal conjugated antibodies and reagent panel kits).

Validated various polymers and metals for metal-antibody conjugation.

Developed scale up conjugation and reagent formulations SOP for production.

Validated metal conjugated antibodies and reagents/buffers.

Researched and compared different clones of antibody from different vendors.

Performed stability test for products to establish product shelf life.

Implemented staining protocols, titration SOP, and QC procedure for each conjugated antibody.

Analyzed data using Cytobank and Flowjo.

Made images and wrote captions for product technical data sheet (TDS).

Creating PowerPoint presentations and presenting data.

Scientist I, Assay Development – Affymetrix, Santa Clara (December 2008 – July 2011)

Successfully launched two product lines.

Developed dual-color chromogenic in situ hybridization (CISH) assay.

Developed 4-plex fluorescence in situ hybridization (FISH) assay.

Developed magnetic bead based bDNA chemiluminescent assay.

Reviewed user manual, wrote SOP, and QC procedures for manufacturing.

Trained FAS and presented demo for various vendors/distributors.

Performed alkaline phosphatase (AP) - DNA conjugation.

Used microscope (bright field & fluorescence) to review data and acquire images.

Manufacturing Group Lead – Panomics, Fremont (February 2003 – December 2008)

Oversaw, managed, manufactured 3,000+ products.

Designed, developed, and printed 47 different types of arrays such as oligo, antibody, protein, etc.

Purified SH2, SH3, and PDZ domain proteins and TF recombinant proteins (GST/HIS-fusion proteins).

Was responsible for manufacturing and inventory of 100+ luciferase reporter vectors.

Manufactured 350+ biotinylated/unlabeled probe pairs and QC each pair via gel shift assay.

Prepared cell lysate for ELISA (from cell culture to nuclear extract), also select antibodies for ELISA kits.

Worked closely with scientists to improve products and troubleshoot customer concerns.

Documented control for QC data and batch records.

Designed kit configuration and created new labels for new products.

Purchased and negotiated price for all raw materials and consumable goods.

Manufacturing Technician/Associate - ChemRx, South San Francisco (August 2002 – January 2003)

Produced drug compounds via advanced organic reactions, such as addition of acylators, amine cleavage, deprotection, solid/liquid extraction and prepared samples for quality control.

Followed written protocols and SOPs to synthesize chemical compound libraries.

Recorded data and maintained chemical inventory, maintenance laboratory, and scientific equipment.

COMPUTER SKILLS:

Proficient in MS Word, MS Excel, and PowerPoint.

Proficient in Q-Pulse Quality Management Software, Microsoft Dynamics AX ERP system, and Zoho database. Familiar with Expendable II ERP system.

EDUCATION:

Master of Business Administration (MBA), Keller Graduate School of Management, December 2014.

Bachelor of Science in Biochemistry and Molecular Biology, University of California, Davis, June 2002.

Bachelor of Science in Botany, University of Yangon, Myanmar, November 1992.

REFERENCES: Available upon request.

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