Manufacturing Medical Device
Resume:
SUMMARY:
Extensive lab experience including column chromatography, conjugations, SDS – PAGE gels, Western Blots, spectrophotometry, protein extractions, buffer preparation, HPLC’s, and reagent preparation. Authored, revised, and reviewed documents. Performed equipment, process, and software validations. Ran and analyzed DOE’s. Set up new Manufacturing lab to receive new product. Analyzed data and made determinations whether or not the product passed guidelines. While in Product Development, developed purification processes and transferred them into Manufacturing. Detail – oriented professional possessing excellent organizational skills.
LAB SKILLS:
● Extensive experience in protein biochemistry.
● Performed SDS – PAGE gels and Western Blots.
● Experienced with HPLC’s.
● Proposed, wrote, and executed equipment, process, and software validations.
● Used of affinity, cation exchange, anion exchange, HIC and gel filtration chromatography.
● While a Product Development Associate, developed processes to purify monoclonal antibodies using HPLC’s and then transferred those processes into Manufacturing.
● Ammonium sulfate precipitations.
● Produced F(ab’)2 with pepsin digestions.
● Protein conjugations to BSA, FITC, Phycoerythrin, HRP, Biotin, and Colloidal Gold.
● Revised manufacturing documents and wrote new procedures.
● UV-VIS spectrophotometry.
EXPERIENCE:
Nanosys, Milpitas, CA 2013 – July, 2015 Chemical Manufacturing Supervisor
● Supervised the Chemical Manufacturing Department of 20 operators ensuring the smooth day-to-day operation of the group.
● Developed system to improve manufacturing documents. Revised documents and authored new procedures.
● Aided in transferring new processes into Manufacturing.
● Member of the Safety Committee and Emergency Response Team (ERT).
● Performed internal audits.
● Implemented 5S and Kaizen programs.
● Set employee goals and conducted performance reviews.
● Resolved CAPA’s.
● Wrote deviations.
Diagnostics for the Real World, Sunnyvale, CA 2012
Manufacturing Supervisor
● Colloidal gold - antibody conjugations.
● Prepared reagents.
● Installed new equipment into lab, and then performed the equipment validations.
● Executed Corrective and Preventive Actions (CAPA’s).
● Revised manufacturing documents.
● Organized new lab, dry room, and warehouse during new product transfer.
● Manufactured, labeled, and packaged medical devices using Manufacturing documents.
Bayer Health Care, Sunnyvale, CA 2006 - 2012
Senior Chemist and Reagent Manufacturing Supervisor
● Improved peptide – BSA conjugation process.
● Determined disposition of critical conjugation product by executing a Design of Experiment (DOE), analyzed data, and then presented the analysis to upper management.
● Purified conjugations via chromatography.
● Performed antibody – latex conjugations.
● Performed SDS – PAGE gels and ELISA’s.
● Analyzed test results and adjusted product to optimize the product.
● Performed peptide glycations.
● Qualified nitrocellulose and cellulose acetate membranes.
● Manufactured reagents.
● Revised manufacturing documents, and wrote new procedures.
● Implemented a system to control chemical inventory and other lab supplies.
● Green Belt trained.
● Used spectrophotometer.
● Revised manufacturing documents.
● Trained as an internal auditor.
● Served on Safety Committee and was Chemical Hygiene Officer.
● Developed Reagent Manufacturing schedule, and then assured that it was followed.
● Green Belt trained.
● Proposed, wrote, and executed process, equipment, and software validations (IQ, OQ, and
PQ).
Hitachi Chemical Diagnostics 1997 - 2006
Senior Chemist and Manufacturing Supervisor
● Extracted proteins from raw materials.
● Manufactured reagents.
● Conjugated HRP to antibodies.
● Decreased scrap rate from 10 percent to less than 1 percent by leading Self-directed Work Teams.
● Proposed method to streamline product approval step resulting in savings of over $75,000 per year.
● Implemented 5S and Kaizen programs.
● Initiated proposal to change product approval that resulted in savings of over $75,000 per year.
● Recrystallized luminol.
● Determined acceptance of protein extracts.
● Ran SDS – PAGE gels and Western Blots.
● Performed BCA to determine protein concentrations of extractions.
● Supervised Manufacturing Department consisting of Wet Chemistry, Assembly, Bottling, Labeling, and Packaging.
● Determined product disposition by leading an interdepartmental group.
● Authored and revised batch records, Standard Operating Procedures, validation protocols, and acceptance reports.
● Attended a week-long seminar on managing multiple projects.
● Assigned work schedules.
Idetek, Inc., Sunnyvale 1995 - 1996
Production Chemist II
● Purification of monoclonal and polyclonal antibodies using gel filtration and affinity chromatography.
● Responsible for the scale-up, production, and optimization of reagents used in Beta Lactam, Aflatoxin, Ceftiofur, Gentamicin, and Chloramphenicol EIA kits.
● QC testing of final products.
● Performed stability studies for kit components.
● Responsible for QC checks in the packaging and assembly department.
● Ran ELISA’s.
Becton Dickinson, San Jose 1989 – 1995
Product Development Associate, Formulations Chemist, and Immunochemist
● Developed processes to purify monoclonal antibodies, and then transferred the processes to Manufacturing.
● Performed ionic chromatography, gel filtration, and hydrophobic interaction chromatography using HPLC’s.
●Conjugated antibodies with FITC, HRP, PE, and biotin.
● Wrote validation reports.
● Experienced with HPLC’s.
● Coordinated schedules of new product releases with fellow members of Self-managed Product Development teams.
● Oral presentations made to Manufacturing to determine the acceptance or rejection of purification processes.
● Wrote Product Development process reports.
● Optimized parameters for Feulgen staining of rat hepatocytes. This staining is done to produce controls for a medical device (CAS instrument) that was developed for the diagnosis/prognosis of breast cancer.
● Hands-on experience with ELISA’s, flow cytometry, and cell culture.
● Selected as a consultant to design and interpret experiments used for a PMA medical device submission.
TAGO Immunologicals, Burlingame, CA 1988 - 1989
Lab Technician II
● Purified polyclonal antibodies using affinity chromatography.
● F(ab’)2 antibody digestions.
● Scheduled and prepared injections for animals.
EDUCATION:
Bachelor’s - Biological Sciences, San Jose State University
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