CURRICULUM VITAE

Name: Steven M Birkitt Address: 59 Whernside Avenue.York. YO31 0QB

Date of Birth: November 1968 Telephone: 07876 222883E-mail: birkolsz@yahoo.co.uk

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Career profile:

Quality-driven manager with strength in stabilising, developing and growing manufacturing operations. Experienced leader engaging the right balance of control and influence, with proven team development

and motivational skills. Demonstrated success in the implementation and responsiveness of operational functions. Varied Class III medical device knowledge and experience, including development, manufacturing,

packaging/labelling and sterilisation of tissue biologics and metals & plastics. Purchasing, planning and manufacturing strengths underpin the product development, V&V and quality

system successes.

Key skills and achievements:

Drive and motivation: Team growth and development to exceed required standards. Employee engagement in the mission, with expected accountability and ownership.

Business growth: Commercial and financial plans achieved, including SME growths of £1M to £6M & £3M to £15M.

Quality: Standards of quality owned in the functions, KPI’s and metrics to measure and improve operational effectiveness and quality of service.

Cost Control: Inventory throughout the business, manufacturing & CI principles, procurement/material sourcing, ERP system implementation.

Standards: Managed production and operational requirements for accreditations: ISO:9001, 13485, MDD, 14160, 22442 and FDA CFR 21 Part 820.

---------------------------------------------------------------------------------------------------------------------------Career History:

Feb 2014 to March 2015 Position: General ManagerForsite Diagnostics (Abingdon Health). York.Developer & Manufacturer of IVD Lateral Flow Devices (LFD)

Set up and improve operational functions to stabilise manufacturing and development processes.Improve the transfer and delivery of NPD projects into production. Implement business planning and controls to achieve required levels of customer service and a responsive support to all sales demands. Identify QMS improvements to maintain ISO accreditation and realise US FDA approval.Achievements: o H&S system launch.o Commence of various planning needs and KPI’s.o Production process controls and ‘right first time’ philosophy, through training and cultural changes.o 5S activities commenced.Ongoing:o QSIP launch and intense change program.o Several improvement plans within Operations functions, and enhance group HR/Personnel support.o Active NPD project management with key deliverables now set.

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Aug 2007 to Jan 2014 Position: Production ManagerVascutek Ltd, a Terumo Company. Leeds.Manufacturer & Developer of Porcine Cardiothoracic Medical Devices

Develop the production and supporting functions to meet all the demands of a growing business with existing and new products. Improve and stabilise supply chain for key raw materials. Implementation of ERP system, with solid operational KPI’s & metrics.Regulatory Standards: ISO 9001:2008, ISO 13485:2012, MD Directive, ISO 13408 (2008), ISO 14160 (2011), ISO 22442 (2010).

Achievements: o Operational support of sales growth from £1M (2007) to £6M (2013).

o Back order eradication from £0.5M.o Transfer and validation of production between 2 UK manufacturing facilities.o Manage OEM business project and fully support customer through, product development, process and

quality system implementation, validations, CE mark and launch.o Significant improvements in process efficiencies and yields.o Operations readiness for customer and regulatory body audits, i.e. LRQA, DEKRA, TGA, BSI.o Recruitment, training & development of staff from 25 to 60 direct & indirect production staff over 2.5 years.o Source and implementation of UK & European supplies of key porcine tissue raw materials.o Generation of KPI’s and operational metrics.o Implementation of planning processes for production and inventory and subsequent ERP system in 2008.o Inventory management to support demands and growth plans of business, including product launches and

clinical trials/studies.o Implementation of business support structures e.g. Production Supervision, Training and Planning

functions.o Implementation of H&S system (RA, COSHH, Hazard ID, Committee).o CI / Kaizen / Lean Sigma activities - derived from the various principles. o Validation planning and activities for production environments, equipment, processes and staff.

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June 2003 to June 2007 Position: Manufacturing Operations ManagerTissue Science Laboratories plc. Leeds.Manufacturer of Porcine Dermal Collagen Medical Devices

Manage and develop the operations of the TSL production facilities to achieve the growth plan of the young company within the medical devices industry.Develop systems and processes to maintain compliance and safety whilst improving productivity and efficiencies.Regulatory Standards: FDA CFR 21 Part 820 QSR, ISO 9001:2000, ISO 13485:2003, MD Directive, ISO 13408 (2008), ISO 11137.Achievements: o Operational support of sales growth from £3M (2003) to £15M (2007).o Validation of production environments, equipments, processes and staff.o Transfer of Clean Room Production from sub-contract to in-house.o Manage engineering and maintenance for all plant and equipments.o Recruitment and training of staff for Operations growth from 15 staff to 42 permanent and 10 temporary in

20 months.o Operations readiness for customer and regulatory body audits, i.e. FDA, LRQA, TGA.o Generation of KPI’s and operational metrics.o Implement inventory management and production planning systems.o Inventory levels to support demands and significant growth of business and distributors/partners.o Inventory management to support product launch and clinical trials/studies.o Implementation and development of supporting structures to manage all operations department’s growths

and improvements.o Implementation of Stores/Warehouse/Logistics/Shipping functions, CI process, H&S system.

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April 2001 to May 2003 Position: Master Production SchedulerDePuy International Ltd (a Johnson & Johnson Company). Leeds.Global Manufacturer of Orthopaedic Implants and Instruments.

Generate and manage the total MPS for all manufacturing business units within the Leeds facilities to achieve inventory plans through facilitation of the S&OP process. Collate and analyse forecasting, market intelligence, historical demand, business trends, operational resource, capacities and product/process knowledge to meet customer demand in a seasonal business. Plans to support Operational Strategies, business growths and product lifecycles.Manage planning system and analyse product planning data to optimise manufacturing processes and batch sizes. Support and advise manufacturing planners in departmental planning and data management.Regulatory Standards: FDA CFR 21 Part 820 QSR, ISO 9001:2000, ISO 13485:1996, ISO 11137.Achievements: o Key role in implementation of ‘JDE One World’ in Leeds as part of global integrated system.o JDE ‘Super User’ to test system processes, write PD’s, write training documentation and train ‘End Users’

for planning, shop floor control, sub-contract and links with purchasing.o Varied inventory and financial targets achieved including; product range reduction programmes, FG

inventory reductions, obsolescence reduction.--------------------------------------------------------------

Nov. 1997 to April 2001 Position: Manufacturing PlannerDePuy International Ltd. Leeds

Achievements: o Key role in successful implementation of Lean Manufacturing process. Total WIP reduction of £1M. to

£270ko Successfully planned the integration of DePuy and JnJ Orthopaedics products and manufacturing into

DePuy’s facility after business merger.o Various product launches through BU.o Full and PMI inventories achieved to launch new products to market.o Reductions in FG/WIP/RM levels as part of obsolescence plans.

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April 1997 to Nov 1997 Position: Purchased Finished Goods Planner – temporary contract.Aug. 1996 to April 1997 Temporary contracts. Buyer – Leeds. Purchasing Officer – Knaresborough

Nov. 1993 to Aug 1996 Position: BuyerStream International Ltd, Wetherby. (Formerly RR Donnelley UK Ltd)Print, Bind, Software Replication and Documentation.

Controlling the Purchasing function within an MRPII environment. Achievements:o £825k saving over 2 year contracted paper supply.o Sourcing, negotiation and purchase of raw materials, finished goods, products and services with an

average spend of £12million p.a.o Implementation of Strategic Stock and Kanban system in printed raw materials usage.o Reporting and providing analysis of all expenditure, savings, stock usage/turns and inventory levels direct

to the European Purchasing Director.o Implement vendor JIT supply and source to support MDQ and customer specifics.o Collaboration with other facilities to single source on a European basis. o Implement and manage the company AVL, including supplier assessment and improvement programs.

Aug. 1992 to Nov 1993 Position: Stores Team Leader – Printing and kit production.Oct. 1990 to August 1992 Position: Senior Storeman Raw Materials – Extruded rubber automotive parts.April 1989 to October 1990 Position: Storeman – Printing and kit production.July 1985 to April 1989 Position: Senior Salesman.

Additional Information

Computer software applications:Microsoft Office Suite and various Inventory Management/Financial/Purchasing MRP systems i.e. JDEdwards OneWorld, SAP R/3, PRMS on AS400, Avalon, Swan, Navision, MFG Pro.

Membership: Member of the Institute of Operations Management (MIOM).Education & Training Detail

o ISO:13485 Updates (LRQA), Updates in Use of Tissues of Animal Origin (BSI)o Lean Sigma White Belt Training. o Product end use and surgical techniques.o Management Development Program (Ged Welch Consulting)o IOSH Managing Safely course.o Roffey Park Management Development Program,o Irradiation and Method 2 Validation. FDA Audit Awarenesso QSR, cGMP, Aseptic Techniques & Basic Microbiology.o S&OP (Oliver Wright), Lean Manufacturing (Deloitte & Touche), 5S (Deloitte & Touche).

Sept. 1996 York College of Further and Higher EducationCIPS Course, Foundation Stage Subjects (only):Business Accounting, Management Principles and Practice.

Sept. 1980 Burnholme Secondary Modern School. York- June 1985 C.S.E. grades

French, Mathematics, English & Studies, Chemistry, Humanities, Art & Design, Physics, Geography.

Personal Profile

Married with children. I have varied interests and enjoy the big outdoors and the noisy indoors. I keep an eye on most sports but the playing days are no more. Non-smoker with a full clean driving licence.