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Janssen Latina site
a journey to
Supply Chain Excellence

Luca Russo, General Manager
November 6th 2013

0
0

0
Janssen Supply Chain Vision
Transforming Our World:
Delivering affordable medicines to anyone, anywhere, any day

Our Mission
Be recognized as a lean & very competitive pharmaceutical
manufacturer for J&J to bring Innovation into reality !!!

1
Janssen Latina, Italy
Be recognized as a lean & very competitive pharmaceutical manufacturer for J&J to bring Innovation into reality !!!

Plant Space (Mfg)
• Land: 1.313.000 sq ft
• Facility Size: 591.000 sq.
ft. (including ext
technical areas)
• Facility footprint:
341.000sq. ft.
• Total covered area:
503.000 sq. ft.

Major Products
• Rispedal, Reminyl
• Invega, Incivo
• Intelence, Prezista,
Edurant
• IBL, Imodium, Motilium
• Jurnista, Tramadol
• Sporanox
• Zytiga,
• Zyrtec, Tylenol,
Benadril, Simply sleep

Utilization/Shifts/Quality
• Utilization 75% (based
on 24/7)
• 24hr*7 days shift pattern
• +1700 FG sku’s
• FDA approved since ’95
• Last 5 FDA inspections
approved
• ISO 14001 certified
• OHSAS 18001 certified

People
• People: 522.5 HC (incl.
38 global)
• Salaries: 156
• Wages: 220
• Others: 146.5
• Exempts: 118
• Non-exempts: 404,5

Sales / Production
Costs**
• Sales Supported: 4 BN$

Product Launches
• 100% on-time launches

• Capital: $ 16 MM
• Conversion Cost: $ 67
MM (excl. IT)
**(YE 2012)

*(FBP2013)

(76 in 2012)

• 24hrs rapid launches
• 2013 Launch plan:
Intelence 25 mg tabs
TMC278 25mg tabs
Prezista 800 mg tabs
Prezista Glide tabs
BG12 120mg capsules
TMC435 capsules
Canagliflozin tabs

Technology&Capabilities
• Solids:Tabs,Caps(5.7BN)
• Liquids: Shampoos,
Solutions (700 Tons, 14 MM
bottles)
• Spray powder (100Tons,
4MM cans)
• Packaging: Blisters, Bottles,
Sachets, Wallet
• High level of automation and
integration

2014 Vision
• Capacity to produce 6.2 BN
units
• Fast execution: all lines at
5x3
• Unit cost reduction of 30%
• Full supplier integration
• Excellence in compliance
and customer service
• Pipeline development:
talents and Global leaders
Latina

QEHS and Compliance
Quality organization productivity:
Increased flexibility to
support volume and
copmlexity growth

Quality Highlights:
One Quality System as
outcome of intellectual

Date

Audit

2007

• Saudi Arabia HA
• FDA

2009

• AIFA
• KFDA

2010

•
•
•
•

2011

• Turkish HA
• AIFA
• KFDA

2012

• Japan
• AIFA
• Kenia

2013

EHS Highlights:

• FDA
• MOCK TMC435
• Mochida

synergy with all regulations.

ANVISA
AIFA
FDA
AIFA

No Smoking Site since 2007
ISO 14001 Certified since 1999
OHSAS 18001 Certified since 2005
Sound EHS Compliance Profile
2003 MAARS 4-4-4
2006 MAARS 4-5-4
2009 MAARS Green
2012 MAARS Green

3
Understanding Latina: “culture of change”
an History of Engagement , Change mgmt and Results
• Pharma RX, OTC,

Operating mode: Flexibility & Adaptability

•

• Global Pharma,

including Japan,
Stent coating
• Business Change
(MD)

• FDA approved
• Large complexity
• Local production
• Small complexity

•
•
•

generics, medical
devices
Best Solid center in
J&J
Process Oriented
Engaged
Organization
System Based
Compliance

• Consumer,

Techfidera, Zytiga,
Canaglifozine
• Reliable org
• Talent development
• Process centered org

732

506

523

377
322
218
150
40

1980
Local business

1990
Technology &
International

2000

2005

Center of excellence
& customer dedication

2008

2010

Launch accelerator

2012

2013

Benchmark for costs,
compliance & customer service
4
Today challenges
NEW BUSINESS

NEW
VOLUMES

NEW
TECHNOLOGIES

5
LATINA LEAN JOURNEY
2001-2003
REDUCE PROCESS
VARIABILITY
•Cycle time &
Process
variability reduction
(6σ)
•Maint. Excellence &
OEE improvement
•Quality Improvement
•Process Automation
•System Integration

2004-2005
REDUCE CYCLE
TIME

•Key Suppliers
involvement
•Customer Integration
•Cycle Time Reduction
•Productivity increase
•Planning reengineering
•Solid Area reengineering
•Digital Factory

2005-2006

2007-2008

2009-2011

DEPLOY FLOW & PULL

INTEGRATION

SUSTAIN
INTEGRATION

•Internal Value Chain
•Inventory reduction
Stock Down (RM, PM)
Consignment stock
RW application with
supplier
Wip control &
Kanban system
•Flow Visual Management
•Internal Benchmarking

•Key Suppliers
integration
•Postponement
•Integrated Change
Mng.
•Lean application to all
Transactional areas
•Organization
simplification
•Cost competitiveness
•Internal & External
Benchmarking

•Full Suppliers
integration
•E2E stream
synchronization &
flowing
•Extensive
Benchmarking
•Robust Organization
•Continuous
Improvement

2011-2013
REINFORCE
INTEGRATION
•Extensive Suppliers
integration
•E2E stream
synchronization & flowing
•Customer oriented culture
•Talent Development
•Reliable Organization
•Change management/site
master plan
•Process automation &
robustness
• TDDB

Integration
Integration
Integration

Pull
Flow
Stability

Official LMA 11
Official LMA 13

Sensei LMA 09

Internal LMA 07
Official LMA 08

Official LMA 06

LMA 2013
preparation
LATINA SUCCESS LEVERS 2011-2013
CHANGE
MGMT

RELIABILITY

AGILITY&
ADAPTABILITY

ORGANIZATION
STRENGHT

PEOPLE

CUSTOMER
FOCUS

INNOVATION

7
Understanding Latina: Change management

8
Critical Success Factor: Innovation
The backbone of our history:Integration of People, Process & Technology
NEXT Decade

Globalization JSC

Plant Activity & Efficiency

•Must add value.

J&J Factory
MES
Shop Floor Automation
Global Q&C systems

•Must help people.
Third Decade

Regional Fill/Finish
EuRoPe2
PES (Best Practice)
Integration
Operational Intelligence (Best practice)

Second Decade

INTEGRATION

Quality & Compliance Systems
Automatic Materials Handling System

First Decade

BASEMENT

Computer Integrated Manufacturing
Electronic Batch Record System
Laboratory Integrated Manag. System

1982-1991

1992-2001

2002-2011

Decades

2012-2021
Customer Focus: Customer Focus
Dep Value Streams:

PLANNING
•Consumer
•Bottles
•Risperdal
•Mfg/Pkg E2E

QC
MFG
•Low vol
•Fluid Bed
•Dry Granulation •High vol
•Japan

E2E value streams:
•Pharma
•Consumer FW
•Japan
•Prezista
•Daktaryn
•Dolormin
•Tylenol s
•Narcotics
•NPI
•Launches

QA
•Pharma
•Consumer FW
•Japan

E2E VALUE STREAM

PLANNING

S
T
R
E
A
M

QA

CONSUMER FW

D
E
P
V
A
L
U
E

QC

MFG

C
O
N
S
U
M
E
R

R
I
S
P
E
R
D
A
L

B
O
T
T
L
E
S

E
2
E
M
F
G
P
K
G

F
L
U
I
D
B
E
D

D
R
Y

JAPAN
PHARMA

H
I
G
H

G
R
A
V
N CONSUMER
O
U
L
L NARCOTICS
U
A
M
T
ZYTIGA E
I
O
N
NPI/LAUNCHES

L
O
W
V
O
L
U
M
E

P
H
A
R
M
A

C
O
N
S
U
M
E
R

J
A
P
A
N

10
Critical Success Factor:People Development
• Top Management visibility
• Compensation strategy (incl. Operator)
• Global roles

• Strong connection with
University to attract top
talents (Blue Eyes)
• Internal growth & targeted
external injection

• Shop floor experience
• Job rotation (Intra-Extra Plant)
• Campus Mode
• MORE Program

11
Developing Leaders

12
Developing Leaders

MORE

Managers On the Roadof Excellence
Reliable Results

14
Business Impact of Latina in 2013
Reputation & Brand Equity

OTC Recovery

Growth

Launch the Pharm NPI pipeline

TMC435

Sustain

Reliability

15
Deliver Customer Value
Last 5 years results:
100% on-time launches, including 24hrs launches

Cost/unit

120
100
80
60
40
20
0
2009

2010

2011

2012

2013

16
Credo & engagement plan
Credo continue to grow
while high rotation level
and people increase

Key elements & focus areas
1.

Leadership model: “Supervisor a key role”, “more”

2.

Engagement & commitment: “People make it happen”, “Credo execution leaders”

3.

Simple, concrete & business oriented initiatives

4.

Create & sustain a positive & innovative work environment
17
LEAN TRANSFORMATION

• Adaptive culture and flexibility, attitude to drive the change.
• Will of reshaping our future through continuous improvements.
• People People People : passion and satisfaction for the Job !

18

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L'intervento di Luca Russo, General Manager Janssen Cilag al "Supply Chain Award for Apics training" di Advance School

  • 1. Janssen Latina site a journey to Supply Chain Excellence Luca Russo, General Manager November 6th 2013 0 0 0
  • 2. Janssen Supply Chain Vision Transforming Our World: Delivering affordable medicines to anyone, anywhere, any day Our Mission Be recognized as a lean & very competitive pharmaceutical manufacturer for J&J to bring Innovation into reality !!! 1
  • 3. Janssen Latina, Italy Be recognized as a lean & very competitive pharmaceutical manufacturer for J&J to bring Innovation into reality !!! Plant Space (Mfg) • Land: 1.313.000 sq ft • Facility Size: 591.000 sq. ft. (including ext technical areas) • Facility footprint: 341.000sq. ft. • Total covered area: 503.000 sq. ft. Major Products • Rispedal, Reminyl • Invega, Incivo • Intelence, Prezista, Edurant • IBL, Imodium, Motilium • Jurnista, Tramadol • Sporanox • Zytiga, • Zyrtec, Tylenol, Benadril, Simply sleep Utilization/Shifts/Quality • Utilization 75% (based on 24/7) • 24hr*7 days shift pattern • +1700 FG sku’s • FDA approved since ’95 • Last 5 FDA inspections approved • ISO 14001 certified • OHSAS 18001 certified People • People: 522.5 HC (incl. 38 global) • Salaries: 156 • Wages: 220 • Others: 146.5 • Exempts: 118 • Non-exempts: 404,5 Sales / Production Costs** • Sales Supported: 4 BN$ Product Launches • 100% on-time launches • Capital: $ 16 MM • Conversion Cost: $ 67 MM (excl. IT) **(YE 2012) *(FBP2013) (76 in 2012) • 24hrs rapid launches • 2013 Launch plan: Intelence 25 mg tabs TMC278 25mg tabs Prezista 800 mg tabs Prezista Glide tabs BG12 120mg capsules TMC435 capsules Canagliflozin tabs Technology&Capabilities • Solids:Tabs,Caps(5.7BN) • Liquids: Shampoos, Solutions (700 Tons, 14 MM bottles) • Spray powder (100Tons, 4MM cans) • Packaging: Blisters, Bottles, Sachets, Wallet • High level of automation and integration 2014 Vision • Capacity to produce 6.2 BN units • Fast execution: all lines at 5x3 • Unit cost reduction of 30% • Full supplier integration • Excellence in compliance and customer service • Pipeline development: talents and Global leaders
  • 4. Latina QEHS and Compliance Quality organization productivity: Increased flexibility to support volume and copmlexity growth Quality Highlights: One Quality System as outcome of intellectual Date Audit 2007 • Saudi Arabia HA • FDA 2009 • AIFA • KFDA 2010 • • • • 2011 • Turkish HA • AIFA • KFDA 2012 • Japan • AIFA • Kenia 2013 EHS Highlights: • FDA • MOCK TMC435 • Mochida synergy with all regulations. ANVISA AIFA FDA AIFA No Smoking Site since 2007 ISO 14001 Certified since 1999 OHSAS 18001 Certified since 2005 Sound EHS Compliance Profile 2003 MAARS 4-4-4 2006 MAARS 4-5-4 2009 MAARS Green 2012 MAARS Green 3
  • 5. Understanding Latina: “culture of change” an History of Engagement , Change mgmt and Results • Pharma RX, OTC, Operating mode: Flexibility & Adaptability • • Global Pharma, including Japan, Stent coating • Business Change (MD) • FDA approved • Large complexity • Local production • Small complexity • • • generics, medical devices Best Solid center in J&J Process Oriented Engaged Organization System Based Compliance • Consumer, Techfidera, Zytiga, Canaglifozine • Reliable org • Talent development • Process centered org 732 506 523 377 322 218 150 40 1980 Local business 1990 Technology & International 2000 2005 Center of excellence & customer dedication 2008 2010 Launch accelerator 2012 2013 Benchmark for costs, compliance & customer service 4
  • 7. LATINA LEAN JOURNEY 2001-2003 REDUCE PROCESS VARIABILITY •Cycle time & Process variability reduction (6σ) •Maint. Excellence & OEE improvement •Quality Improvement •Process Automation •System Integration 2004-2005 REDUCE CYCLE TIME •Key Suppliers involvement •Customer Integration •Cycle Time Reduction •Productivity increase •Planning reengineering •Solid Area reengineering •Digital Factory 2005-2006 2007-2008 2009-2011 DEPLOY FLOW & PULL INTEGRATION SUSTAIN INTEGRATION •Internal Value Chain •Inventory reduction Stock Down (RM, PM) Consignment stock RW application with supplier Wip control & Kanban system •Flow Visual Management •Internal Benchmarking •Key Suppliers integration •Postponement •Integrated Change Mng. •Lean application to all Transactional areas •Organization simplification •Cost competitiveness •Internal & External Benchmarking •Full Suppliers integration •E2E stream synchronization & flowing •Extensive Benchmarking •Robust Organization •Continuous Improvement 2011-2013 REINFORCE INTEGRATION •Extensive Suppliers integration •E2E stream synchronization & flowing •Customer oriented culture •Talent Development •Reliable Organization •Change management/site master plan •Process automation & robustness • TDDB Integration Integration Integration Pull Flow Stability Official LMA 11 Official LMA 13 Sensei LMA 09 Internal LMA 07 Official LMA 08 Official LMA 06 LMA 2013 preparation
  • 8. LATINA SUCCESS LEVERS 2011-2013 CHANGE MGMT RELIABILITY AGILITY& ADAPTABILITY ORGANIZATION STRENGHT PEOPLE CUSTOMER FOCUS INNOVATION 7
  • 10. Critical Success Factor: Innovation The backbone of our history:Integration of People, Process & Technology NEXT Decade Globalization JSC Plant Activity & Efficiency •Must add value. J&J Factory MES Shop Floor Automation Global Q&C systems •Must help people. Third Decade Regional Fill/Finish EuRoPe2 PES (Best Practice) Integration Operational Intelligence (Best practice) Second Decade INTEGRATION Quality & Compliance Systems Automatic Materials Handling System First Decade BASEMENT Computer Integrated Manufacturing Electronic Batch Record System Laboratory Integrated Manag. System 1982-1991 1992-2001 2002-2011 Decades 2012-2021
  • 11. Customer Focus: Customer Focus Dep Value Streams: PLANNING •Consumer •Bottles •Risperdal •Mfg/Pkg E2E QC MFG •Low vol •Fluid Bed •Dry Granulation •High vol •Japan E2E value streams: •Pharma •Consumer FW •Japan •Prezista •Daktaryn •Dolormin •Tylenol s •Narcotics •NPI •Launches QA •Pharma •Consumer FW •Japan E2E VALUE STREAM PLANNING S T R E A M QA CONSUMER FW D E P V A L U E QC MFG C O N S U M E R R I S P E R D A L B O T T L E S E 2 E M F G P K G F L U I D B E D D R Y JAPAN PHARMA H I G H G R A V N CONSUMER O U L L NARCOTICS U A M T ZYTIGA E I O N NPI/LAUNCHES L O W V O L U M E P H A R M A C O N S U M E R J A P A N 10
  • 12. Critical Success Factor:People Development • Top Management visibility • Compensation strategy (incl. Operator) • Global roles • Strong connection with University to attract top talents (Blue Eyes) • Internal growth & targeted external injection • Shop floor experience • Job rotation (Intra-Extra Plant) • Campus Mode • MORE Program 11
  • 14. Developing Leaders MORE Managers On the Roadof Excellence
  • 16. Business Impact of Latina in 2013 Reputation & Brand Equity OTC Recovery Growth Launch the Pharm NPI pipeline TMC435 Sustain Reliability 15
  • 17. Deliver Customer Value Last 5 years results: 100% on-time launches, including 24hrs launches Cost/unit 120 100 80 60 40 20 0 2009 2010 2011 2012 2013 16
  • 18. Credo & engagement plan Credo continue to grow while high rotation level and people increase Key elements & focus areas 1. Leadership model: “Supervisor a key role”, “more” 2. Engagement & commitment: “People make it happen”, “Credo execution leaders” 3. Simple, concrete & business oriented initiatives 4. Create & sustain a positive & innovative work environment 17
  • 19. LEAN TRANSFORMATION • Adaptive culture and flexibility, attitude to drive the change. • Will of reshaping our future through continuous improvements. • People People People : passion and satisfaction for the Job ! 18