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Manufacturing Manager

Location:
Vallejo, CA
Posted:
January 15, 2013

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Resume:

Kevin Dixon

Email: *********@********.***

Address: *** ****** ******

City: Vallejo

State: CA

Zip: 94590

Country: USA

Phone: 707-***-****

Skill Level: Experienced

Salary Range: $72,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Kevin V. Dixon

300 Shasta Street

Vallejo, CA 94590

Home: 707-***-**** Cell: 707-***-**** E-mail: *********@********.***

Summary of Qualifications

Skilled, experienced, and educated in manufacturing operations, operations support, supervision, and project teams. Training and skills include media preparation, fermentation, recovery and purification, filling, packaging, and production support areas. Manufacturing experience includes producing licensed commercial and clinical bacterial, mammalian cell, and human biological pharmaceuticals in a GMP environment. Media and fermentation experience include operating 10L, 100L, and 100L vessels for down stream processing of the protein. Recovery and purification experience includes operating mixed-matrix, affinity, and ion-exchange columns. Operated ultra filters and concentrated eluates for final bulk filling operations. Additionally assisted in the start-up and decommissioning of manufacturing operations. Noted as a person of quality, with the ability to deliver services in a cost effective and timely manner.

Experience

Bayside Solutions/Genentech, 2011 - Present

* Bioprocess Technician III

o Manufacturing Support:

o Calibrate, maintain and troubleshoot process equipment to include:

Nova Bioprofile blood, gas analyzers

Advanced Instruments 3900 Osmometers

Genesys spectrophotometers

Broadley-James dissolved oxygen and pH probes

Pressure gauges and process hoses

Repair manual and pneumatic valves

Prepare media for large scale bacterial fermentation

Prepare and autoclave batch and harvest filter assemblies

Dixon Living Trust, 2009 - Present

* Estate Manager

o Maintain estate property and assets in accordance to California State law, and the executors

o Perform financial duties to keep the estate viable which include:

Renting properties

Paying bills and filing taxes

Managing estate assets

Hiring contractors

Manage daily operations

Genentech, 2000 - 2008

Sr. Bioprocess Technician

* Manufactured commercial products in a GMP environment

* Operate and troubleshoot fermentation vessels and equipment

* Operate bench top analysis equipment to support fermentation operations

* Perform environmental monitoring

* Collaborate with other departments to complete the manufacturing process

* Reviewed process trends to correct in-process production problems

* Communicated process findings with associates and management.

ADDITIONAL EXPERIENCE

* Hired, trained, and supervised hourly, salaried, contract and intern employees

* Authored batch production records (tickets), SOP`s, and validation reports

* Scheduled and planned departmental work

* Performed media operations

o Mixed components and sterilized media for fermentation

o Sterile filtered media into 1000L bins for continuous profusion fermenters

o Performed aseptic connections to new fermentors as required.

* Performed fermentation operations

o Operated 10L, 100L, and 1000L fermentation vessels

o Maintained in vitro cells

o Harvested proteins for recovery and further purification

* Operated HPLC columns

o Prepared buffers

o Performed column operations including repacking gels

o Eluted and concentrated final product for bulk filling operations

* Assisted in the installation and implementation of a MOD 300 DCS

* Troubleshoot and work with plant engineers to:

o Create better process equipment

o Develop new methods and techniques for manufacturing operations.

* Assisted in the development of a site wide training program for employees

* Developed and maintained departmental summer intern program

* Managed, operated, and maintained pilot plant operations and annual budget

* Participated on cross-functional teams to include: Hiring, PAI Auditing, Safety, Training, and Quality Improvement

* Performed 483 Compliance Officer duties to include:

o Resolving FDA 483 citations

o Ensuring CAPA`s were implemented and maintained

* Coordinated building and equipment maintenance

* Assisted in pre-licensing auditing inspection team duties and activities

* Reviewed batch production records for accuracy and completeness

* Performed duties as a building safety officer

* Completed Shimadzu TOC Analyzer training

EDUCATION

A.S. in Computer Applications, Solano Community College, (Spring 2013)

A.S. in Management, Solano Community College, spring 2013

A.A. in General Science, Solano Community College, 1988

A.A. in Mathematics, Solano Community College, 1989

CERTIFICATIONS

Microsoft Office Specialist, Solano Community College, Spring 2013

Management, Solano Community College, Spring 2013

Microsoft Office Master, Solano Community College, 2012

Computer Applications Specialist, Solano Community College, 2011

E.I. DuPont Safety Training Observation Program (STOP) Trainer, 1996

Petroleum Laboratory Specialist, US Army

MILITARY EXPERIENCE

U.S. Army, Honorably Discharged

AWARDS

Alpha Gamma Sigma Society, Solano Community College, 1980

Good Conduct Medal, U.S. Army, 1979



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