Manager Manufacturing

David K. Starr

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

Fishers, Indiana 46037

Home - 317-***-****; Cell - 317-***-****

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

PROFESSIONAL EXPERIENCE

ROCHE DIAGNOSTICS CORPORATION, Indianapolis, IN 1990 - Present

(Formerly Boehringer Mannheim Corporation)

Supply Chain Manager, Materials Management & Production Inventory Control

(6/06 - Present)

Direct the production planning, inventory management, raw material

purchasing, master scheduling, shop floor control, capacity requirements

planning and manufacturing packaging operations for the Clinical Chemistry,

Drug of Abuse and Therapeutic Drug diagnostic product lines. Accountable

for 4000+ material numbers.

Manage about $50M USD of raw material, work-in-process and finished goods

inventories using SAP to support desired customer service levels, cash

flow, inventory turns and scrap/obsolescence business objectives.

Develop the annual Production Plan to support divisional sales for about

$492M USD of finished goods.

Supervise a staff of (6) Planner/Buyers, (2) Shop Floor Control Specialists

and (3) Packaging Supervisors.

Accountable for 40+ packaging employees, annual volume of 2.9 million kits

and $3M USD operating budget.

Create and maintain performance reports for senior management to review

production plan execution, inventories, order fill rates, backorders,

capacities, production variances and scrap.

Serve as the Manufacturing representative for the business area on the

Material Review Board (MRB) and Validation Review Board (VRB). Also

responsible as the designated proxy for the Director of Production.

Currently working on a global cross-functional project team to transfer the

manufacturing operations and product portfolio from Indianapolis to

Mannheim, Germany by Dec-2010 without interrupting product supply.

Key Accomplishments:

9. Served as team leader to represent all Indianapolis manufacturing

business areas on the Roche Pandemic Planning team. Led a cross-

business team and worked with senior leadership to prepare strategic

plans.

10. Optimized the lot size strategies for the Drug of Abuse product line

to realize $5.8M USD cost savings.

11. Reduced backorders by 40% without increasing inventory and improved

customer order fill rate to 99%.

12. Worked with external print supplier to implement a process improvement

and cost reduction project that reduced material numbers (5 to 1),

eliminated inventory (kanban) and yielded $400K annual cost savings.

Manager, Manufacturing Operations (6/97 - 6/06)

Efficiently and cost effectively managed the manufacturing processes for

Clinical Chemistry, Drug of Abuse and Therapeutic Drug diagnostic reagents.

Product mix included 450 end items and 1400 subassemblies.

Directly supervised a staff of 8 supervisors responsible for the following

departments: Chemical Raw Material Testing, Bulk Compounding, In-process

Bulk Testing, Dispensing, Packaging and 2nd & 3rd Shifts.

Accountable for 95+ production personnel and scientists along with an

operating budget of $7M USD.

Supervised a team of (2) Shop Floor Specialists responsible for production

scheduling and capacity planning.

Actively worked with manufacturing teams to optimize production schedules,

determine budget requirements, ensure safety and regulatory compliance,

promote quality initiatives and facilitate process (cost) improvements.

Key Accomplishments:

18. Reduced machine set-up times by 75% and production cycle times by 60%.

19. Reduced production scrap by 70% and rework expenses by 65%.

20. Reduced work in process (WIP) inventories by 80%.

21. Generated a total of $18.9M USD in production cost savings over a 9-

year period.

22. Integrated the Drug of Abuse production process from New Jersey to

Indiana without supply interruptions.

23. Designed an inclusive job qualification program to promote workforce

flexibility and career development.

24. Improved annual perfect attendance rate for employees within the

Manufacturing area from 9% to 46%.

DAVID K. STARR

ROCHE DIAGNOSTICS CORPORATION, Indianapolis, IN (continued)

Quality Manager, Configuration Management (5/95 - 6/97)

Managed a staff of 13 technical specialists responsible for creating and

controlling product configuration documents per FDA and ISO 9001

guidelines. These documents included kit configurations, specifications,

manufacturing instructions, testing procedures, bills of material, routings

and standard operating procedures.

Worked on cross-functional project teams to coordinate the transfer of new

products into Manufacturing.

Prepared cost analyses for new product launches and key process

improvements for senior management.

Served as a primary business resource to help validate, integrate and

launch SAP into the Operations area.

Key Accomplishments:

29. Prepared the Quality System documents to help the business area

achieve ISO 9001 certification.

30. Created a document control process to improve the integrity of product

design and pilot history records.

31. Reduced the overall document change control review, approval and

implementation cycle time by 65%.

32. Redesigned (simplified) the format for all production documents to

help reduce material rejections by 28% and temporary deviations by

50%.

Supervisor, Project Engineering (4/94 - 5/95)

Managed new product transfer projects originating from R&D, OEMs and

international business units.

Prepared transfer strategies, manufacturing specifications, purposeful

variation experiments and scale-up studies. Worked with key functional

areas to develop project plans, schedules and detailed timelines.

Supervised a staff of technical specialists responsible for creating

scientific and engineering documents to support the launch of new products

into Manufacturing.

Manufacturing Project Engineer (4/92 - 4/94)

Transferred new products, processes and technologies into Manufacturing.

Assisted with R&D development, wrote new product documentation, built pilot

lots, implemented process improvements and worked on cross-functional

project teams to launch new products.

Production Chemist (8/90 - 4/92)

Compounded bulk liquid, powder and lyophilized diagnostic reagents.

Worked with R&D personnel to transfer new products into bulk manufacturing.

Served on the Emergency Response Team as a fully trained Hazardous Material

Technician.

SERADYN DIAGNOSTICS INC., Indianapolis, IN

1986 - 1990

Immunoassay Manufacturing Coordinator (6/88 - 8/90)

Responsible for raw materials planning, production scheduling and

immunoassay kit manufacturing.

Prepared and supervised the weekly work assignments for compounding,

dispensing and packaging.

Designed pilot lots to trouble-shoot production issues and customer

inquiries.

Transferred new products and technology from R&D to bulk manufacturing.

Manufacturing Compounding Scientist (7/86 - 6/88)

Compounded bulk liquid, powder, lyophilized and latex particle diagnostic

reagents.

Assisted with the production dispensing and kit packaging operations.

DAVID K. STARR

EDUCATION

Master of Business Administration University of Indianapolis

Graduated with honors Indianapolis, Indiana, May 1991.

Inducted into Delta Mu Delta National Honor Society

Bachelor of Arts in Biology Wabash College

Crawfordsville, Indiana, May 1986.

CERTIFICATION

Certified Quality Auditor by the American Society for Quality (ASQ),

December 2009.

Certified Supply Chain Professional (CSCP) by APICS.

The Association for Operations Management, September 2008.

Certificate in Leadership Excellence from American Management Association,

May 2006.

Master Certificate in Manufacturing from Saddle Island Institute, October

2005.

Certified Quality Manager by the American Society for Quality (ASQ), April

2000.

Master Certificate in Project Management from George Washington University,

October 1997.

Certified in Integrated Resource Management (CIRM) by APICS,

The Association for Operations Management, April 1995.

Certified in Production and Inventory Management (CPIM) by APICS,

The Association for Operations Management, December 1991.

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