Manager Manufacturing

MARK C. HAYES

** ******** *****, ***** *****, Arkansas 72715

954-***-****, *******@*********.***

Clinical & Commercial Manufacturing/Production Management … Facility Design, Start-Up, & Commissioning

Equipment/Process Validation & Qualification … Integration of Technology … FMEA & Risk Analysis

Quality & Performance Improvement … Supply Chain/Logistics … Strategic Planning … Cost Reductions

A dynamic leader with more than twenty years experienced in building and leading manufacturing operations through

innovation and empowerment. Recognized for process change and improvement, seamless method transfers and new

technology with implementation through training, direction, and development of operating staff. High attention to

detail and efficiently adapts to change, challenges, and competing priorities providing strong and sustainable quality

gains with operational excellence.

PROFESSIONAL EXPERIENCE

Pel-Freez Biologicals, LLC, 2013 – 2014

Rogers, Arkansas

Bio Production Manager (8/13 – 7/14)

Managed a team of production personnel in the manufacture of high quality raw materials and intermediates for

biological research and diagnostic manufacturing. These products include lyophilized tissue powders, serum products,

plasma, blood complement, tissues, antibodies, and other biological raw materials.

• Executed improvements in manufacturing and purchasing decreasing operations spending by approximately

$275,000 where 73% was directly related to Cost of Goods Sold.

• Identified and implemented new technology for production of purified and lyophilized gamma globulin products,

completing the project $125,000 under anticipated capital expenditure.

• Reduced total percentage of necessary manufacturing over-time dollars spent from over 5% to less than 1%.

Cytovance Biologics, Inc., 2008 – 2010 & 2012 – 2013

Oklahoma City, Oklahoma

Central Services Manager (1/12 – 8/13)

Trained and mentored manufacturing personnel in activities related to the production support of cell culture and

purification processes. The department’s main focus was raw material dispensing, media and buffer formulation,

tubing and filter assembly, liquid filtration, and autoclaved goods. Additionally responsible for oversight of facility

sanitization and personnel.

• Volunteered to create, define, and manage a new Central Services Group resolving an urgent operations need.

• Manufacturing Lead in the development and implementation of a company-wide, module based, training system.

• Proceduralized the format and content requirements for Manufacturing Batch Records.

• Developed matrix for tracking of manufacturing deviations and significantly reduced process deviations

associated with media and buffer formulation.

• Authored over fifty buffer formulation batch records.

• Planned, sourced, and ordered raw material and chemicals required for multiple formulations up to 112 x 200 liter

units for a single production run.

• Wrote and delivered performance reviews, assisted in goal setting and professional development, conflict

resolution, and progressive disciplinary systems.

Manager of Manufacturing Technical Support (5/11 – 1/12)

Served as a technical knowledge base providing ongoing support to Manufacturing for existing process technology as

well as the transfer of new processes and equipment.

• Authored and executed multiple validation/qualification protocols and final reports.

• Investigated process deviations and out-of-specification results or occurrences to determine root cause and affect a

preventative and/or corrective action.

Manager of Upstream Manufacturing (7/08 – 1/10)

Managed manufacturing personnel and processes for mammalian cell culture in the production of therapeutic proteins

and monoclonal antibodies. Responsible for upstream activities from cell thaw, scale-up, maintenance, harvest and

clarification. Additionally responsible for cell banking activities.

• Communicated to senior management, operations plan for projects including timelines, internal and external

resources/costs, key deliverables and key data issues.

• Extensive client interface and Project Management. Business Development through process/facility capabilities

presentations and proposal generation.

• Provided key input to hiring process with ongoing responsibilities for training and mentoring.

• Responsible for technical transfer, project timelines, and deliverables.

• Traveled internationally to successfully execute process technology transfer from client to in-house

manufacturing.

• Biological Safety Officer

Goodwin Biotechnology, Inc., 2010 - 2011

Plantation, Florida

Technical Project Manager & cGMP Compliance Officer (2/11 – 4/11)

Develop effective working relationships with internal/external partners and cross-functional project teams. Provide

technical support to Upstream Manufacturing. Responsible for training program and cGMP compliance.

• Tasked with review and revision of all manufacturing documentation within the scope of compliance.

Manager of Upstream Manufacturing (1/10 – 2/11)

Provided hands-on management to Upstream Manufacturing staff. Utilized 20L packed bed perfusion bioreactors and

full expansion and production in Hyper Flasks for adherent cell lines.

• Reviewed and completed final report for Installation/Operational Qualification of a 250L and 500L bioreactors

and executed sterility challenge.

• Evaluated and revised existing flask-based cell culture process to reduce number of aseptic manipulations by over

50% thereby reducing the risk of contamination.

Cook Pharmica, LLC, 2007 - 2008

Bloomington, Indiana

Manufacturing Associate III (9/07 – 7/08)

Performed start-up and validation activities for newly built upstream manufacturing suite containing a 600L seed

bioreactor and 2 x 2500L production bioreactors.

• Executed spray ball coverage (riboflavin) testing and swab recovery testing for Clean In Place (CIP) validation as

well as thermal mapping, bacteriological challenge, and media sterility holds for Steam In Place validation.

• Wrote multiple Standard Operating Procedures for upstream manufacturing processes and procedures.

• Assisted in the development and training for a new Media Preparation department.

• Manufacturing lead in the creation of electronic batch records.

• Bioprocess Technology Overview Instructor

Lonza Biologics, Inc., 2001 - 2007

Portsmouth, NH

Senior Manufacturing Operator (2/05 - 7/07)

Served as Special Projects Lead on multiple projects as required. Assisted department supervisor in planning

and assigning daily work activities for Upstream Manufacturing.

• Performed daily batch record review.

• Subject matter expert for all start-up, operational, and shutdown activities in a suite utilizing 3 x 200EH

Wave disposable bioreactors, 3 x 100L, 4 x 1000L, 4 x 4000L seed bioreactors, 4 x 20000L production

bioreactors, 8 feed vessels, a 20000L Harvest vessel, continuous flow, disk stack centrifuge, and depth

filtration skid. Additionally, in inoculum preparation and cell expansion.

• Performed daily sampling, testing, and cell counting.

• Served as interim supervisor to Media Preparation department.

• Special Project Lead in initiative creating training/proficiency documentation for all upstream

manufacturing processes. The Performance Measures identified key functional and knowledge

requirements for training certification.

Validation Lead (9/03 - 2/05)

Collaborated with Engineering on capital projects, facility design and expansion, equipment sourcing and

procurement, commissioning and validation. Responsible for engineering documentation and equipment turnover

packages.

• Authored, and executed where applicable, User Requirement Specifications (URS), Functional Requirement

Specifications (FRS), Design Qualification (DQ), Commissioning Qualification (CQ), Installation Qualification

(IQ), Operational Qualification (OQ), Process Qualification (PQ), and Process Validation documentation.

• Demonstrated expertise in of Clean In Place (CIP) and Sterilize In Place (SIP) theory and cycle development.

• Extensive experience with change control systems (engineering, document, and process changes)

• Review and revision of piping and instrumentation diagrams (P&IDs) and isometric drawings.

• Confined Space Entry Supervisor

• Accepted a temporary assignment of over two months at Lonza’s manufacturing facility in Slough, UK to assist in

training and development of Good Manufacturing Practices.

Manufacturing Production Support Supervisor (7/02 - 9/03)

Supervised day and evening staff of the Media Preparation Department across two facilities.

• Coordinated and planned activities for cleaning and sterilization of process vessels and associated piping,

formulation, filtration, and pressure transfer of media.

• Supported 24/7 manufacturing processes.

• Served as member of Facilities Readiness Team and Contamination Response Team

Manufacturing Operator II & Manufacturing Operator III (2/01 - 7/02)

Maintained and operated manual systems and equipment for 2 x 2500L perfusion bioreactors.

• Performed daily sampling and monitoring and feeds as required.

• Inoculum preparation and cell expansion.

Additional professional experience and references available upon request.

EDUCATION AND MILLITARY EXPERIENCE

Gorham High School

Gorham, Maine

Graduated 1987

US Army

Ft. Meade, Maryland

Power Generation Equipment Specialist (52D) & cross trained as Medical Specialist (91A) 1987 - 1989

US Army School of Engineering

Ft. Belvoir, Virginia

Power Production Engineering 1987

University of Maine

Orono, Maine

Chemical Engineering 1989 – 1990

ADDITIONAL PROFICIENCIES & TRAINING

Mammalian, Microbial, and Insect Cell Lines … Airlift, Stirred Tank & Perfusion Bioreactors

Disposable Bioreactor Systems (WAVE 25, 20/50 & 200 and Sartorius STR50 & STR200)

Clean Room Environments ISO8 – ISO5 … Isolator Technology & VHP Sterilizers

HEPA Filtration … Biological Safety Cabinets … Chemical Fume Hoods & Dust Collectors

Incubators … Shakers, Stirrers & Rollers … Atomizers & Spray Drying

Lab & Pilot Scale (5L – 100L) … Fermenter (120L) … Mid/Large Scale (500L – 20000L)

CUNO, Pall & Millipore Depth Filtration System … Disk-stack & Tubular Bowl Continuous Flow

Centrifuges

Homogenizers & Microfuidizers … Water Baths & Sonicators … Cabinet Washers & Autoclaves

Controlled Rate Freezers & Lyophilizers … UF/DF Skids & Pumps … Single Use Mixers

YSI, NOVA BioProfile & Blood Gas Analyzers … ViaCell, Cedex & Manual Cell Counting … Kaye

Validator

Vial Washers, Dehydrogenation Ovens, Manual and Automated Filling & Tube/Plate Coating Equipment

Large Scale Blenders, Grinders, Chilsonators & Sifters … Blister Pack Filling Machines

Filter Integrity Test Methodology and Equipment for Hydrophobic & Hydrophilic Filters

Allen-Bradley & Alleghany-Bradford PLC Interface, Provox, DeltaV, Unicorn, Foxboro, SCADA & BAS

Systems Hummingbird DMS 5, ThermoScientific LIMS, SAP, MANMAN, Aspen PIMS & Ability 585

Microsoft (Outlook, Word, Excel, Access, Power Point, Project, & Visio) Adobe Acrobat, JMP Statistical

Software

KnowledgeWire, TrackWise, WebTrack, eMaint & MP2

Certificate courses in Management Development, Supervisory Skills, Effective Hiring, Conflict Resolution,

Basic First Aid, and CPR.

Contact this candidate