Production Operator Manufacturing Associate

LARRY WAYNE TAYLOR

http://www.linkedin.com/pub/larry-w-taylor/50/718/521/

336-***-**** ***********@*****.*** Mebane, NC 27302

SUMMARY:

A seasoned professional with 20 years of experience in biotechnology with proven results in a fast-paced environment coupled with research and development. This includes unicorn software for the operation of HPLC skids, tempering skids, ABB, Delta V for use in automated processes. Method development, high mechanical aptitude, organization, teamwork, and attention to detail are my strengths. The ability to be flexible and relate to individuals at all levels in an organization including problem solving and effective use of resources to manage and drive project completion within determined timelines.

EXPERIENCE:

Quality Assurance Specialist II 6/21- present Merck, Durham, NC Mentors product/process quality, and represents Quality on the shop floor. Leads special projects.

Adherence to good manufacturing and documentation practices while maintaining Quality checks and SAP transactions required to support release of product.

● Mentor in 100% process document/logbook audits for accuracy and completeness and works closely with IPT in a team environment to ensure timely review and documentation is Right First Time (RFT).

● Provide support directly to the production floor, to include oversight for adherence to cGMPs, RFT completion of production GMP documentation, environmental monitoring (EM), review and classification of atypical events including assessing product impact for EM events, providing Quality oversight to alarm events during processing, review and approval of incursions, review and approval of batch record documentation, along with review and approval of Quality related SOP’s providing support for effective investigation of deviations.

Validation Engineer III Consultant 11/19- 4/21 PSC Biotechnology, Pomona, CA

Ensure successful ramp-up of recovery processes and lead expert role in developing the project.

Provide input, review and approve design and requirement documents. Review and approve technical specifications with effective team building and motivation.

Engineering Project Lead promoting goals and objectives for validation.

Schedule and assist with qualification/validation for many projects with full compliance with policies, procedures, and industry guidelines in the performance of IQ/OQ/PQ and other validation activities.

Validation Protocol Development

Temperature Mapping

Autoclave/Sterilization

Project Management

Change Control Adherence

Operational Improvements

Operation Technician II PSF 11/12- 10/19 Merck, Durham, NC

Merck Master Train the Trainer Certification 8/16

Merck Yellow Belt Certification 9/15 No expiration

● Assisted the team in a lead role in the performance of manual and automated operations, general maintenance

and support functions necessary for the production of vaccines 35 RFT batches.

● Achieved Safety Recognition 2/19

● Implemented transfer system to reduce the number of dropped/cracked plates by 10 percent.

● Actively participates in HAZOPS, 5S, kaizen events, or any other operations, lean six-sigma, quality,

and safety initiatives.

Serve on safety, quality walkthroughs and other committees.

● Provide all documentation real time and clerical functions necessary to allow proper accountability

and traceability of product through MES.

● Maintain inventories using SAP, and transports all required equipment, materials, supplies and products.

● Perform general maintenance and assists in troubleshooting of equipment.

● Completed sampling/in-process testing supporting the manufacturing and validation process for current processes.

● Identified and addressed compliance through weekly walkthroughs, environmental, safety GEMBA,

and process deviations with reduced observations.

● Scheduled environmental monitoring during processing and records results in GLIMS system.

● Doubled workforce in the training of new 7 employees per year.

Aseptic Production Operator I 7/12 – 11/12 Fresenius Kabi, Raleigh, NC

Achieved RFT setup and adjusted equipment to ensure proper operation, including disassembly and installation required per SOP.

Followed up to ensure that the operation of steam sterilizers, vial/parts washers, compounding equipment, de pyrogenation tunnel, vial capper, tray loader, filler, lyophilizer, and integrity tester are according to SOP.

Collaborated with Quality and Engineering staff in the status of manufacturing, process investigations, deviations, reconciliation and rejections, and the training of new employees to meet the production schedule of the team.

Industrial Process Associate Specialist 11/11- 05/12 Medicago USA, Durham, NC

● Designed and fabricated process improvement waste distribution system to facilitate the centrifugation process.

Troubleshooted and collaborated with R&D and process support to assure smooth process transition in the manufacturing to produce live viral proteins and the completion of 10 million doses of flu vaccine in less than 20 days.

Incorporated and trained personnel on process improvements generated by the Process Manager and Engineers to produce an efficient process in a start-up environment.

Took the lead in cGMP compliant production in documentation and organizational skills to meet critical timelines in production, centrifugation, fermentation, harvest/digestion, infiltration, and seeding in the greenhouse.

R&D Scale-Up Technician 05/10-02/11 - DuPont, Durham, NC

Organized and executed R&D experiments in the precipitation of precious metals, and

mediums per design of experiment (DOE) to produce new products.

Performed testing procedures of new products.

Recorded experiment details with test procedures, results, routine analyses, and calculations.

Changed equipment, products, or test methods recommended, and worked with team on prototype design.

Validation Specialist I 02/08-06/10 - STIEFEL a GSK Company, Durham, NC

Led the execution of IQ, OQ, and PQ of 2 glassware washers, 7 various mixers, fillers and other GXP equipment located in the start-up of the pilot plant.

Troubleshoot and repaired Waters HPLC and Agilent GC equipment with associated detectors, dissolution apparatus, spectroscopic, and small laboratory equipment.

Designed test manifold for calibrating multiple pressure gauges.

Calibrated analytical equipment performed PM’s.

Established wrote and implemented SOP’s for calibration and maintenance of equipment.

Programmed PLCs to ensure all operational parameters meet company requirements

Manufacturing Associate Sr. II 12/00-02/08 - DIOSYNTH, Morrisville, NC

Managed the manufacture of biopharmaceutical materials used in small scale, clinical and commercial products that include protein recovery producing inclusion bodies, and cell isolation.

Managed unit operations HPLC, UFDF, centrifugation, and homogenization.

Executed cleaning validation protocols, and equipment validation.

Reviewed formulation and batch records real time.

Procured water samples to ensure quality testing was according to company requirements.

Performed change controls and internal audits.

Trained new staff members on cGMPs, SOPs and other related support functions.

Senior Analytical Chemist 03/99-09/99 - SCOTT SPECIALTY GASES, Durham, NC

● Analytical services provided increased by 30 percent.

● Designed in process analysis station to increase productivity with less waste.

Coordinated work assignments for GC, HPLC lab and FTIR analyses of blended gases.

Maintained NIST and SRM trace ability criteria for gas standards, weights, and balances and method development for new compounds.

Established and maintained QA/QC protocols.

Lab Supervisor 01/98-03/99 TRIANGLE ENVIROMENTAL SERVICES, Durham, NC

● Analytical services provided increased analysis by approximately 40 percent.

● Fabricated and designed fuel gas system, gas transfer manifolds, and recovery systems.

Scheduled and produced production reports to ensure that time lines were met.

Led the implementation of 110 percent QC testing program.

Liaised customers to provide technical solutions for problems experienced in the

field.

Assisted sales to provide additional items that may have been needed to meet project goals.

Analyzed data with review to verify the accuracy of analyses.

Maintained instruments with troubleshooting.

Trained all new employees on all new and current procedural practices.

Planned and developed various methodologies and delegation of assignments as needed.

EDUCATION:

NORTH CAROLINA A & T STATE UNIVERSITY Greensboro, NC

Bachelor of Science / Professional Biology and Minor Chemistry

PUBLICATIONS:

W. Stollings, J. Venezia, and L. Taylor. Effects of QA/QC Procedure

Changes of Method 25 Analysis and 50ppm Method Detection Limit,

Measurements of Toxic and Related Air Pollutants May 1996.

W. Stollings, J. Venezia, and L. Taylor.

Problems Encountered with Method 25C/3C MSW Landfill Projects,

Measurements of Toxic and Related Air Pollutants May 1997.

W. Stollings, J. Venezia, and L. Taylor. A Solution for Method 25

Sampling in a High Moisture Environment using a Dual Trap Procedure,

Measurements of Toxic and Related Air Pollutants May 1997.

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