Eisai Production Operations Employee Development

Production Operations Employee Development Creating and Transferring Knowledge… …for the manufacturing of products that benefit both patients and their families. Safety GMP PharmaWork

Employee Development Model Organizational Systems Skills/ Training Recruiting Performance Management Development Compensation Required Competency (GMP/EHS) Personal Effectiveness Competency Technical Knowledge and Skills Competency Business Application EHS Quality (GMP) Production Operations Specific TeamworkQuality Professionalism IntegrityRespect Job Specific Foundational Core

Project Management Proposal July 19, 2006 Why did we develop this program?  Employee Survey Results  Meet our Future Business Needs  Remain Globally Competitive

Project Management Proposal July 19, 2006 Employee Survey Results  Rewards of work survey conducted 85% Response Rate  Areas Employees Not Satisfied:  Pay Process  Talent & Performance Management  Career Opportunities

How do we know if we are getting returns on our investments ? Quality Improvements Reduced Turnover Improved Employee Satisfaction Highly Productive and Knowledgeable Workforce

Then How We Got From…. Now

Then  Why do my co-workers get paid more or the same as me and I have more knowledge and do more?  Is there a way to have a more objective method to measure skills, knowledge and performance?  What is required to move to the next position?  How can we get more training?

Program Objectives Employees are paid based on knowledge, skills and performance. Employees know what is expected of them in their current position. Employees know what it takes to move to the next position. Employees have individual development plan.

Career Ladder Technicians and Team Leads Technicians Working KnowledgeProficientMastery Levels 3 3W3P3M 2 2W2P2M 1 1W1P1M Team Leads ProficientMastery Levels 3 3P3M 2 2P2M 1 1P1M Level Progression Skill Step Progression Groups Included: Manufacturing, Packaging, Mechanics

Project Process Job Descriptions (written/evaluation/pay scale) 2. Data Gather for Task Analysis 1. Career Ladder Learning Plan Learning Resources Made Available 3. Competencies Mapped (skills/knowledge defined) Qualification/Assessment Documents Developed Employees Assessed/ Mapped to Level & Pay

ACTIVITYTASKS/STEPSEQUIP’T / TOOLS/ DOCS KNOWLEDGE / SKILLS / ATTITUDE PERFORMANCE EXPECTATION S PERFORMANCE MEASUREMEN T LEARNING (Knowledg e transfer) Line AOperate Palace Bottle Unscrambl er  Turn on/off Main power  Start/Stop equipment  Correctly identify cases  Load bottles into hopper  Turn on/off air supply  Monitor component flow  Reload component s SOP #PK88 GMP’s Line overview Location, purpose of equipment component s Basic equipment operation HMI screens and equipment controls Able to keep equipment operating 100% Able to perform changeovers without assistance, according to SOPs, and within a specified time Able to clean equipment and work areas according to SOPs Line efficiencies as measured by throughput # completed batches Presentation/De moTransfer skills = OJT with use of references (20 hrs. Filler, Labeler; 5 hrs. other units) Reinforce concepts /practice skills = Hands on with trainer feedback and explanation Data Gather Task Analysis

Mapping to the Job Description Major Activities

Tasks/Steps Competency Grouping Competencies Working Knowledge ProficientMastery Equipment OperationXXX Clean EquipmentXXX ChangeoverXXX Write policies and procedures for equipmentX (Level 3) Training others on equipmentXX TroubleshootingX)XX Adjustments requiring physical intervention, I.e., changing codes, adjusting PE’s, etc. X (Level 2 and above) X InspectionXXX

Competencies Performance Levels Mastery (M) CompetenciesWorking Knowledge ProficientMastery Equipment OperationXXX Clean EquipmentXXX ChangeoverXXX Write policies and procedures for equipment X (Level 3) Training others on equipment XX TroubleshootingX)XX Adjustments requiring physical intervention, I.e., changing codes, adjusting PE’s, etc. X (Level 2 and above) X InspectionXXX

Packaging Position Chart

Assessments

Develop Assessment

Skill Assessments

Skill Assessment

Qualification Process Module 1 (ie Cleaning) Module 2 Module 3 Course Module Delivered (0nline Classroom Self Study Module Delivered (0nline/ Classroom Self Study) Knowledge Check OJT OJT Performance Evaluated Performance Evaluated Qualified Module Delivered (Classroom /Online/ Self Study)

Qualification

Pay and Progression System End Results

Training Opportunities

LevelsCompetencies Level III 4 lines Same as Level II Competencies In addition to: Training Administration; Presentation Leadership/Mentoring Advanced Troubleshooting (Mechanics Skills) Document Revisions/Writing EHS Certification SAP Investigations Maintain PI Sheets Level II 3 lines Same as Level I Competencies In addition to: Documentation Review SAP MS Word/Excel Perform carry over Pull and Verify Samples Level I 2 lines Line Operations Proper Documentation Practices Training other employees on Equipment Computer (Windows, , eLLIE (SOP Reading; Online Training) GMP Knowledge Proper Documentation Practices Team Player Communication Line Supply TRAINING PROVIDED Shutdown Training –Public Speaking –On-the-Job Training –Mechanical Skills –Solid Dose Overview –Technical Writing Onsite Training –Microsoft Word, Excel, PowerPoint –Deliberate Documentation

Knowledge Space

Screen shot to be added SIMULATION - MANUFACTURING

COMPUTER BASED COURSES - SAFETY

Team Training

The right pieces … for Performance Competencies Career Ladder Skills/ Knowledge Skills/ Knowledge Training

Business Impact Quality Improvements Reduced Turnover Improved Employee Satisfaction Highly Productive and Knowledgeable Workforce

Program Check In

Focus Group Feedback  Pace  Revaluate timing (ie pay increase 3 mos., 6 mos?)  Training  Limited due to staff  Pay  Market Analysis  Make Lead Pay and Level/Step Info Public

Management Response Action: Will not change pace at this time. Program is new; difficult to change without sufficient data. ACTION: Provide additional training options:  Micro sampling (environment / water)  Instrument calibration  Cleaning validation (swab sampling) Options will continue to expand based on business opportunities, (e.g., in-process lab) ACTION: Hire temps to provide opportunity for our full time regular employees to train in other areas. ACTION: Add wage information for Manufacturing, Packaging, Leads and Mechanics to Public Drive ACTION: Annual Survey of Industry Wages

Learnings  Successes  Vice President Support  Employees involved at each step  “Pull” by employees for training  Interest in expanding programs to other areas  Challenges  Ability to rotate based on business needs  Adding additional training modules

QUESTIONS