Michael Matson

*** **** ***** *****

Sanford, NC 27330

919-***-****

acevw0@r.postjobfree.com

OPERATIONAL AND TECHNICAL SKILLS

** ***** ** ********** ** biotechnology / vaccines manufacturing operations

to include roles in training, supervision, operations, and warehouse. All

roles require cGMP and Quality mindset.

Technical and Compliance Skills Include:

Experienced in production supervision and training

Column chromatography, UFDF Systems, LPC Skids

Cleaning validation of process equipment

UNICORN and DCS system operation

Trainer for site on GMP, gowning, train the trainer (OJT), and aseptic

techniques.

SOP's, Batch Records, Deviations, CAPA's

RELEVANT EXPERIENCE

NOVARTIS VACCINES / PROUNLIMITED, Holly Springs, NC May 2010 - June

2014

Global leader in vaccines manufacturing and development

Manufacturing Specialist, Training (ProUnlimited) August 2012 - June

2014

Responsible for managing the training program and all associated activities

for a 100+ primary manufacturing organization to include supporting the

larger training organization.

Site Training: Deliver and facilitate educational trainings in alignment

with site initiatives. Provide site wide trainings for GMP related

activities, gowning, and aseptic technique / cleanroom behaviors.

Training Coordination: Maintain the web based training system

(webTraining) for all associates in primary manufacturing to include

performing all administrative activities. Support the Quality department

and associates in maintaining training plans and records within

webTraining.

Compliance: Develop and revise compliance educational materials, including

web-based training modules. Ensure that primary manufacturing maintains

compliance in relation to training objectives including creation / revision

of related SOP's and OJT's. Investigate deviations related to training to

include developing and delivering CAPA trainings for primary manufacturing.

New Hire Orientation: Developed NHO for primary manufacturing organization

and administer the two week technical program.

Train the Trainer Program: Developed site wide Train the Trainer program

and administer the program for the site.

Partnership: Partnered with BTEC to develop and outsource supplemental

training. Act as training network partner within the site and support

overall training strategy in alignment with the Quality Training

department.

Metrics: Track training activity completion and report training metrics to

management including bi-annual reviews of training matrix with department

managers.

Manufacturing Associate III, Downstream (Novartis) May 2010 - August

2012

Responsible for providing the technical skill-sets necessary to manufacture

high quality biologicals in a safe, compliant, efficient, and cost

effective manner.

Served as a processing and equipment expert in downstream by performing and

training others on all equipment and production related activities.

Lead associate for commissioning and validation activities.

System owner of Absorption process.

Interfaced with process automation systems (e.g, PAS, BAS, Delta V,

UNICORN).

Lead the collection and tracking of area metrics and process control data.

Investigator in root cause investigations and CAPA completion for Level I

and II deviations.

Implemented process steps according to defined SOP's and BPR's.

Properly documented activities in accordance with cGMP's.

Authored and/or modified production documentation.

Handled biologically and chemically hazardous goods.

Supported a high performance teamwork environment.

DIOSYNTH BIOTECHNOLOGY, RTP, NC September 2001 - May 2010

GMP Drug Contract Manufacturing Organization for the Biopharmaceutical

Industry

Supervisor / Shift Lead, Purification January 2008 - May

2010

Responsible for supervision and operation of Purification Suite to ensure

production of active pharmaceutical ingredients in FDA regulated

environment in compliance with cGMPs to include the following duties:

Coordinated daily production activities with direct management and planning

department to maintain production schedule.

Management of associates including performance management, timesheet

approval, and adequate personnel resources.

Proactively monitored training requirements for associates to ensure

process/equipment operates without delay or deviation.

Performed daily shift change activities.

Ensured equipment is qualified and within calibration prior to the start of

each

campaign.

Communicated with support groups to ensure raw materials/consumables are

staged and available prior to the start of each campaign.

Created/revised SOP's and Batch Records.

Investigated and closed deviations within specified timeline.

Member of the Safety Committee and Medical Emergency Response Team.

Sr. Manuf. Assoc., Purification March 2006 - January

2008

Manuf. Assoc. II, Purification December 2004 - March

2006

Manuf. Assoc. I, Purification November 2003 - December

2004

Worked in 5 different purification suites on a total of 7 different

projects.

Executed purification techniques utilizing validated process equipment to

remove containments from host protein.

Performed CIP and SIP of process equipment.

Performed in-process UV spectrophotometer measurements to ensure protein

recovery.

Performed soft part changeover and preventative maintenance on production

equipment.

Certified Task Trainer on core manufacturing fundamentals.

Review Batch Records and SOP's.

Manuf. Assoc., Fermentation/Cell Culture December 2002 -

November 2003

Worked in 3 different fermentation suites on a total of 4 projects.

Successfully completed a cell culture start-up campaign.

Executed in-process testing including, but not limited to, pH,

conductivity, glucose and spectrophotometer measurements to monitor the

progress of fermentation and cell culture.

Operated production equipment (cleaning, sanitization/sterilization and

process operations).

Trained on the use of fermentors, bio-reactors, aseptic techniques,

sanitization, portable vessels, use of incubators, autoclaves, and other

related equipment.

Performed weigh-outs and measurements to obtain raw materials and

intermediates required for manufacturing processes.

Reviewed and/or updated SOP's and Batch/Formulation Records pertaining to

relevant equipment and procedures.

Warehouse Associate September 2001 -

December 2002

Responsible for receiving, storing, and distributing material, tools,

equipment, and

products within the Biotech manufacturing facility by performing the

following duties:

Counted and safeguarded all material entering the plant; prepared necessary

documentation.

Identified and reported all inbound and damaged goods.

Established highly accurate inventory records through cycle counting.

Assisted with scheduling of work for production.

Delivered material to plant personnel.

Maintained shelf life and lot controls.

Loaded and unloaded trucks.

Utilized the bar coding system for inventory control and entered all

receipts to the computerized inventory system.

Assured proper labeling, handling, and storage of all chemicals used in the

area.

PRIOR WORK EXPERIENCE

SED International - Account Manager Sept. 2000 - April

2001

Merisel Americas, Inc. - Account Manager Jan. 2000 - Sept. 2000

Static Control - Team Lead (ESD Dept) April 1997 - Jan. 2000

Weyerhauser - Machine Operator Aug. 1995 - Jan. 1997

EDUCATION

Computer Technology Program - Certification Dec. 1999

ECPI Technical College

Raleigh, NC

COURSEWORK

Applied Mechanics, Integrated Computer Applications, Electronic

Mathematics, Electronic Fundamentals, Electronic Principles and

Applications, Digital Electronics, Communications, Customer Service,

Computer Upgrade and Maintenance, Windows NT Workstation/Server, Internet

Explorer, and Prep Courses in CNE, CNA, and A+

Contact this candidate