Montgomery Street, San Francisco, CA94105(555) 432-1000, resumesample@example.com
Summary
I am an accomplished biochemist with 19 years of industry experience in the molecular diagnostics field specializing in the development of life science products. Extensive knowledge in regulatory compliance of ISO: 9001 and FDA regulated laboratories, related to quality control, process development, and product development cycle for small molecules. Demonstrated expertise in investigations of non-conforming product, development of testing procedures and for SOP development. Proficient with analytical method development, documentation, interpreting data, and problem solving. Instrumental in the development of a small biotech company into a multi-million dollar enterprise.
Skills
Broad based expertise in oligonucleotide synthesis and chemistry. Familiarity with maintenance of cell lines for bacteria and CHO cell cultures.
Analytics: Strong analytical background and characterization of impurities in oligonucleotides and small molecules used in oligonucleotide synthesis.
Experienced in: LC-MS, HPLC /UPLC, UV-Vis spectrophotometry, high throughput robotics platforms for oligonucleotide synthesis and purification, NMR data analysis, Western blot, DNA extraction, DNA, RNA and protein purification, SPE, and LPE.
Software: Empower, Mass Lynx, Softmax Pro, ChemiDoc Imaging, Chromelon, FileMaker Pro, ChemDraw, Outlook, MS word, Excel and PowerPoint
Accomplishments
Developed analytical test methods for purity, identity, quality and functionality for base nucleotides with thermal liable protecting groups.Reported findings and evaluation to upper management for new product review.Patent issued in 2014.
Developed analytical test methods for purity, identity, quality, functionality, stability and product use information on a new series of fluorescent dyes for use in Biosearch qPCR probe systems.Reevaluated the manufacturing process of an existing dye.
Implemented changes in the production process for a higher yielding and more stable dye.
Worked with a collaborator to study the rate of photo cleavage on DNA library -coated beads with a photo cleavage linker.
Developed micro-scale chemistry and HT DNA synthesis program for the manufacturing of small- scale oligonucleotides.
Created training program on DNA synthesis chemistry for staff.
Experience
02/2017 to PresentResearch Assistant InternValmet Corporation | Roslindale, MA,
Bacterial cultivation for selection of E.
coli BL21 transformed with pBK AcKRS3, pCDF PylT GLD1, and/or pACYC GroEL/ES-TF, plated archived bacteria samples to determine if still viable.
Performed Western blot, bacterial transformations and protein purification for mass spec analysis.
Attended academic conferences on research and aging.
04/2013 to 09/2016Product ManagerWood Plc | Baton Rouge, LA,
Responsibilities: Product management and development of DNA Synthesis products and immunochemicals.
Coordinated with internal teams- customer service, R&D, manufacturing, quality, engineering, upper management and marketing to determine testing requirements, product specifications, cost, pricing, and delivery of new products; developed testing processes and procedures on new products, starting materials and related intermediates; compiled documentation of all testing performed and data collected; managed transfer of new products, documentation, associated product specifications, testing SOP's and controls from R&D to manufacturing and quality control; developed testing processes and procedures for customer contract manufacturing based on requirements; assisted chemical manufacturing team to increase yield, efficiency and quality of new and existing products; provided customer and internal technical support; performed investigations on non conforming products to determine root cause analysis; worked with quality to address supplier corrective action requests, created product use information, positioned products in market; educated internal and external stakeholders on new and existing product features; created marketing collateral; worked closely with sales team and participated in sales calls; provided quotes for customers; analyzed and reported quarterly sales data.
02/2000 to 04/2013Quality Control ManagerApex Systems | Danbury, CT,
Responsibilities:.
Analytical: Developed test procedures for purity, functionality, quality and identity of products and assigned product specifications.
Conducted stability testing, set storage conditions and assigned reanalysis periods.
Tracked, trended and analyzed QC data for specific product lines.
Identified and fixed problems associated with instrument malfunctions.
Maintained incident logs.
Performed analysis on incoming goods, intermediates and products, including final inspection.
Compliance: Responsible for maintaining laboratory ISO 9001:2008 compliance.
Created and maintained SOP's for new products, incoming goods, in process materials and products.
Performed review of batch records and data; assigned pass/fail/quarantine disposition to batches.
Maintained QC data records and reports.
Oversaw trending data related to company quality objectives.
Investigated product complaints and participated in CAPA program.
Documented deviations, lead investigations of NCP and participated in material review board.
Recommended and tracked corrective actions.
Participated in customer audits.
Played key role in setting up quality system for ISO compliance.
Validation: Performed validation of testing procedures and methods on new products.
Responsible for analytical development and validation of HPLC methods used for QC testing.
Set up and maintained laboratory equipment validations, calibration records and associated validated programs.
Supervisory: Supervised, managed, hired and directed the training and development of department personnel.
Prioritized chemist workload.
Maintained training files and performed chemist annual review.
Managed new product transfers from R and D to quality control.
Set up and maintained products records in FMP database for all chemical products to include structures, physical information, product use information, testing performed, specifications, pricing and sizes.
Other: Assisted molecular biology lab in sub-culturing of adherent CHO cell line.
10/1997 to 02/2000ScientistBiosearch Technologies | City, STATE,
Responsibilities: Preparation of buffers and DNA synthesis reagents used in the synthesis and analysis of oligonucleotides.
Set up lab instruments and performed validation testing.
Set up bottling program for bottling chemical products.
Maintained inventory of all chemical products.
Other responsibilities included marketing, creating and publishing a catalog of Biosearch products, bottling product, training of new employees, filling orders, and shipping.
Documentation: Produced SOP's for bottling products, buffer preparation and DNA synthesis reagents.
Developed certificate of analysis layout for products and started the development of product use information.
Compiled and created a library of structures for all chemical products.
Quality Control: Tested all DNA synthesis solid supports.
Created and maintained the certificates of analysis for all chemical products.
Education and Training
Expected in Bachelor of Science | BiochemistryMt. Saint Mary's College, Los Angeles, CAGPA: Biochemistry
Activities and Honors
Jewish Family and Children Services
Marin Society of Artist
Skills
enthusiastic people person, advanced problem-solving, great organizational skills, failure analysis, problem analysis and Resolution, Process Improvements,Product Management, Product Research, Quality and Productivity Improvement, Strong Communication Skills, Technical Support, Troubleshooting.
Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.