Microsoft Office Manufacturing

Summary Qualifications Overview

Biopharmaceutical manufacturing techniques: Manufacturing equipment maintenance via Clean-In-Place (CIP) and Steam-In-Place (SIP); utilization of Autoclave equipment, and Buffer Formulation.

Experience with Standalone Computerized Instruments and software such as: Delta V, Unicorn, OSI Pi, Discoverant, HPLC, UPLC, Sctophotometers and TOC Analyzers

Proficient in Microsoft Office applications, Internet Explorer / Outlook and Sharepoint

Strong working knowledge with FDA cGMP regulation and documentation practices

Skilled with aseptic techniques, Buffer Exchange Chromatography, PegYlation, Cation Exchange Chromatography, Ultra Filtration Diafiltration, acid-fast staining, gram staining, basic histological techniques and pH / conductivity analysis

Excellent written and verbal communication skills

Experience working with cross-functional teams

Project Management

Scheduling

Work Experience

Project Engineer

SAVIS Inc. – Amgen (Thousand Oaks), 11/2015 – Present

Familiar with design requirements (URS, FS and other engineering specifications)

Responsible for developing and executing System Development Life Cycle (SDLC) validation documents, IVFT, IQ, OQ, PQ protocols, SAT and Validation Reports

Assess P&ID drawings, accompanying documentation to ensure accuracy with newly installed utilities and large volume tanks

Technology Transfer and Cycle Development

Perform and execute mixing study protocols for tank cleaning efficacy

Draft, revise and execute cleaning validation protocols for large volume batch tanks in order to evaluate the efficacy of a proposed cleaning study that includes the use of a fully integrated clean in place automated skid

Manufacturing Associate I

Baxalta International, Inc. – Biosciences (Thousand Oaks), Clinical Manufacturing 03/2014 – 11/2015

5S Champion

Cleaning Validation Champion

Supported with buffer mixing validation for BAX855

Qualified Lead Investigator responsible for support of non-conformance reports

Support Purification operations for the production of bulk drug substance product

Qualified trainer on a various of processes

Hands on operation, set up, cleaning and sanitization of portable tanks, chromatography columns and filtration systems

Monitor and record critical process parameters, i.e. pH/ Conductivity, pressure, flow rate and UV

Formulate buffer solutions utilizing GDP/GMP regulations

Perform manufacturing sampling, including water sampling, utilizing aseptic techniques

JDE Review/ Verification operator for bulk manufacturing

Qualified on the review of Manufacturing Formula Records (MFR’s and MBR’s) per GDP/ GMP guidelines

Lead and Execute Suite A inventory operations. Team player on the core team for Warehouse Management System (WMS) implementations

Complete relevant paperwork following GDP/ GMP guidelines

Training on the manufacturing process

Provide audit support

Manufacturing Associate I/ HireGenics Contractor

Baxter International, Inc. – Biosciences (Thousand Oaks), Clinical Manufacturing 07/2013- 03/2014

Support Purification operations for the production of bulk drug substance product

Hands on operation, set up, cleaning and sanitization of portable tanks, chromatography columns, filtration systems, cart assembly, and production lines

Research Technician

Medical Packaging Corporation, Camarillo, CA, 02/2012 – 05/2012

Managed strategic projects (Research and Development)

Buffer Formulation

Performed basic laboratory techniques for research and development operations

Utilized aseptic techniques and GCP/GDP documentation practices

Executed autoclave operations and clean room maintenance

Final inspection operations

Education & Training

B.Sc., Biology, University of Central Methodist University Fayette, MO 2012

Yellow (Lean Methodology) Belt Training Thousand Oaks, CA 2014

Green (Six Sigma Methodology) Belt Training Thousand Oaks, CA 2014

Lead Investigator, Qualified Thousand Oaks, CA 2014

Document Author, Qualified Thousand Oaks, CA 2014

Laboratory Information Management System (LIMS) Thousand Oaks, CA 2014

References upon Request

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