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Capabilities Overview
Updated February 2011
Contents
• Business Summary
History, Background & Mission Statement
• Facilities
Capabilities & Systems
• Operational Excellence
Project Management Driven
• Quality
Organization, Philosophy & Current Status
• Organization
Overview
• OsoBio is a contract manufacturing organization (CMO) that focuses on
biologic and pharmaceutical injectable finished drug products – (sterile
liquid, liquid suspension and lyophilized formulations).
• The site has demonstrated the ability to handle virtually any category* of
biological or pharmaceutical product, from clinical to commercial scale,
specializing in difficult and complex products, including potent
compounds, proteins, and monoclonal antibodies.
• OsoBio has an excellent compliance record with approvals from almost
every major global regulatory agency.
• OsoBio is well positioned financially with a solid and diverse customer
base and the backing of a strong ownership group
*does not include beta-lactams
OsoBio – New name, rich history
2008
A group of private
1980 1993 2001 investors acquires
Built by Acquired by SP Pharma the site, returning it
Summa Pharmacia, becomes part
of Cardinal
to its entrepenurial
Medical at the becomes
Health’s PTS roots
current site Pharmacia
Upjohn in division
1995
Adriamycin structure
1988 1997 2007
Purchased by An MBO is Cardinal PTS
Erbamont and executed with is spun off,
renamed current becoming
Adria SP as management Catalent
primary and renamed
product was SP Pharma
Adriamycin
New Mexico Top 10 Manufacturer
Location & Facilities
• Located in North Central Albuquerque
• Four dedicated facilities
– Manufacturing
• 2 Compounding / Formulation areas (4 suites)
• 3 Grade A aseptic filling suites
• 1,230 square feet of lyophilization capacity
– Warehouse
• 139,000 square feet warehouse space
• 2 Vial labeling and packaging lines
• Cold Storage
– Laboratories
– Administration Building
• Current operations are on a 24/5 schedule with capability for 24/7
Manufacturing
• 2 Compounding / Formulation
4272 Balloon
areas Park Road NE
– 3 Grade A aseptic filling suites
– 2 cc to 100 cc vial filling
• 2 TL 8 head filling machines
(continuous glass supply)
• 1 TL 4 head filling machine
(batched glass supply)
– 1,230 square feet of lyophilization
capacity across four Lyos: (410,
410, 300, 108 square feet)
• Sterile liquid, suspension and
lyophilized formulations (Aseptically
filled and/or terminally sterilized)
• Currently 24/5 operation
expandable to 24/7
Inspection, Packaging & Sterile University
Warehousing
o
– 2 – 8 C Cold Storage ~ 7,000 ft2
– Ambient Storage ~10,000 ft2
– Total Warehouse Space ~ 139,000 ft2
o o
– -20 C & - 70 C Storage
– DEA compliant storage
Inspection, Labeling & Packaging
– Inspection: 2 Pace semi automated and 3
Manual Inspection stations
– Labeling machines: 2 Weilers
– Cartoners: 2 Bosch & 1 Jones
4401 Alexander
Sterile University Blvd. NE
– Full mock up of all manufacturing activities
– Allows training without exposing sterile
core or interruption of normal
manufacturing
Support Facilities
Administration Building Laboratories
• Engineering & Maintenance •Chemistry Laboratory
• Metrology • Particle Laboratory
• Validation • Stability
• Technical Operations • QA Documentation
• EH&S • Regulatory Affairs
• Human Resources & Finance • Quality Compliance
.
.
Systems
T
Trackwise for Documentum &
Quality Systems Training
CAPA, Change Manager
Control, Audits, Records, plans &
Complaints, etc. SOPS
Fully Integrated,
State of the Art
Systems
Ross-ERP for Calman for
Production Maintenaice
Lot Status, Calibrations, PM’s,
Inventory, & Work & Qulifications
Orders
Clean Rooms
Grade A
Aseptic Suites
Grade B
Aseptic Support
Grade C Grade D
Compounding Component Prep Classifications
Clean Rooms
Grade D Grade C Grade B Grade A
• Fill lines
• Process equip
• API Handling • Background for • Unloading of
components
• Formulation filling sterilized
Primary Purpose • Vial washing
• Background for • Aseptic storage components
• Equipment
capping • Capping • Loading of
cleaning
lyophilizers
Minimum Air
30 60 155 240
Changes/hr
Maximum non-
viable particle limit 100,000 10,000 100 100
(0.5µm/ft3)
Operational Excellence
Drives the business from multiple
perspectives (Customer,
Employees, Market, Business,
Systems & Formal Project
Improvement
Management)
Continuous
Utilizes Six Sigma as a tool in
process and leadership
development with a formally
trained staff
Embedded, common
methodology deployed across all
operational and functional areas
Project Management
Define
Scope
Regulatory
Equipment
Strategy
A dedicated Project
Manager is assigned to
each project as the primary
customer interface to OsoBio-Client
coordinate all activities Project Team
related to the successful
implementation of the
Project Customer Risk
Needs Mgmt
Timeline &
Budgets
Quality Functions
•Validation
•Regulatory
Quality Systems •Change Control
•Quality Agreements
•APR & Audits
•Media Fills
•Sterility
Microbiology & •Environmental Monitoring
Chemistry Labs
•Stability
•Product Testing
•Aligned with Operations to provide integrated QA support
Manufacturing Quality •Incoming raw material release and finished product AQL
Assurance •Batch Record Review & Release
(MQA) •Computerized Environmental Monitoring System
•Complaints
Strong Compliance Position
Date Agency Type of Inspection Results
Facility Compliance FDA – CBER General Inspection Approved
2005 ANVISA PAI Inspection Approved
• Australia EMEA, MHRA, IMB PAI/General Inspection Approved
• Canadian Authorities FDA – CDER Multiple (2 PAI & 1 General) Approved
• EMEA 2006
Gulf Cooperation Council PAI Inspection Approved
• Gulf Cooperation Council
• NM Board of Pharmacy ANVISA 2 PAI Inspections Approval granted for line 274
2007
• FDA FDA – CDER General Inspection Approved
• CBER EMEA, MHRA, IMB General Inspection Approved
• CDER 2008
FDA-CDER General Inspection Approved
• CVM
NM Board of Pharmacy General Inspection Approved
2009
MHRA - EMEA Product Specific Inspection Approved
FDA – CBER General Inspection Approved
ANVISA Product Specific Inspection Pending
2010
Mexican Health Product Specific Inspection Approved
EMA General Inspection Approved
(No outstanding Observations from any agency)
Diverse Customer Base*
European
31%
Big Pharma
30% Mid Pharma
4%
Emerging
14%
Biotech
21%
*Based on 2010 revenues
Investing for Growth
• Rolling 3-year plan supporting facility maintenance, planned upgrades,
and strategic business opportunities
• Key Projects include
– Pre-purchased tanks & equipment stocked in-house to reduce new
customer timelines
– 152 Filler / Washer / Tunnel: Key equipment upgrade to improve aseptic /
containment capabilities / Improve speed / efficiency
– Pre-filled Syringe Line: Expansion of capabilities offered
– Automated Inspection: Improve glass quality, speed, & efficiency
2009 15%
2010 10% Total Projected Spend
(as a % of revenues)
2011 12%
Organizational Structure
Updated February 2011
Employment Makeup by Function
Technical
21%
Quality
20%
Mfg SG&A
54% 5%
Current total employment ~ 350 people
Senior Leadership Team
Collective Experience exceeds 125 years
Stuart Rose – CEO (Ph.D. Chemistry)
37 years of experience in the pharmaceutical industry most recently as head of Supply Chain Strategies International. Prior
experience includes positions with Penick Corporation (as President/CEO), ICN Pharmaceuticals (now Valeant
Pharmaceuticals) as VP of Worldwide Manufacturing and as VP/GM ICN Europe and SVP for Par Pharmaceuticals.
Jeff Curl – VP Operations (B.S. Biology)
21 years of pharmaceutical experience in sterile manufacturing with Aventis Behring, Cardinal Health, and OsoBio. Joined
Oso’s predecessor company as Director of Operations in 2004 and promoted to current position in 2008.
Susan Schniepp – VP Quality (B.S. Microbiology)
30+ years of professional experience managing quality assurance at Abbott Labs, Antisoma PLC, Hospira and Javelin
Pharmaceuticals Inc. Currently serving on the board of directors for PDA and has served as chairwoman of the Monograph
Development–Psychiatrics and Psychoactives Expert Committee for United States Pharmacopeia (USP).
Julie Miner – VP Finance (B.A. Accounting, C.P.A.)
19 years of accounting experience, 9 years in manufacturing, services & construction and 7 years in corporate accounting.
Ten years of direct manufacturing experience in various roles with General Electric, Cardinal Health, and Catalent.
Milton Boyer – VP Business Development (B.S. Chemistry; M.S. Biochemistry)
21 years of experience in Fine Chemical/Pharmaceutical Sales, Marketing & Business Development. Extensive experience
in API’s and narcotic raw materials. Prior experience includes positions with Siegfried USA and Chattem Chemicals as
Director Sales & Marketing and as Technical Director for Flexible Products Company (Dow)
Organizational Structure
Jeff Curl Julie Miner Susan Schniepp Milton Boyer
VP-Operations VP-Finance VP-Quality VP-Bus Dev
•Manufacturing • Finance • Quality Systems • Sales/Marketing
•Engineering • Cost Accounting • MQA • Contract
•Maintenance • Payroll • Laboratories Management
•Packaging • HR • Regulatory • Project
•Inspection • Benefits Affairs Management
.•Warehouse .• Purchasing .• IQA . • Customer
Service
•Technical
Operations
• EH&S
Summary
Our goal at OsoBio is to be known as:
– An injectables manufacturer that has specialized expertise and experience
to handle the most unique and complex projects, volume-independent.
– A company that sets the standard for regulatory compliance within the
injectables manufacturing industry.
– A company intently focused on customer responsiveness with attention to
detail, flexibility and clear communication.
We welcome the opportunity to discuss your sterile filling
requirements in detail and let us show you how OsoBio can help
meet your manufacturing needs.
Thank You
Please visit our website to learn more about OsoBio
www.osobio.com
