Alan C. Wong
5 Trowbridge Circle, Shrewsbury, MA 01545
Tel: 508-845-2836; Mobile: 508-868-9278; Email: acw3669@yahoo.com
http://webprofile.info/awong/
Global Manufacturing & Operations Professional
Clinical & Commercial Manufacturing | Program & Portfolio Management | Supply Chain & CMO Management
Extensive experience leading global CMC/technical programs, operations, and complex supply chain for biopharmaceutical industry – supporting revenue growth and bottom lines. Successful at building and directing multidisciplined global teams that collaborate as focused units to achieve aggressive corporate objectives. Highly effective
at integrating and leveraging internal organizations, business partners, and global supply chains to develop and deliver
high-quality products at the lowest marginal costs.
Able to define and align strategies, key resources, and process improvements to maximize performance, cycle times,
and yields. Proven track record of directing small & large molecules DS, DP manufacturing, labelling / packaging and
material management. Extensive product / program / CMO management experience has led to FDA/EMEA approved
commercial products that include: Enbrel, Neumega, Factor IX, Eylea, & Arcalyst.
CORE LEADERSHIP COMPETENCIES
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Complex Global Project / Program Management
Multi-Functional Leadership & Collaboration
Strategic Planning & Tactical Execution
Budget, Planning, Financial Analysis & Risk / Cost
Control
 Start Up, Scale Up, Process Design, Development,
Tech Transfer & validation
 Device Development (Autoinjector & Microinfuser)
 Supply Chain, Cold Chain & CMO Management
 Leveraging Strategic Partnerships / Negotiations
 Kaizen & Process Improvements / Metrics
 Clinical/Commercial Manufacturing & Quality
System Establishment
 cGMP Facility Design, Equipment Selection &
Installation
 Technical/Engineering Operations Management
PROFESSIONAL EXPERIENCE
Independent Consultant – Shrewsbury, MA
Self-employed as independent consultant serving companies in US and China.
Apr 2013 – Present
Principal Consultant
Provide consulting services to clients in US and China; areas include manufacturing, supply chain functions, business
operations, facility design, construction, quality assurance, strategic planning, and financial analysis.
 $10+ million potential product penetration facilitated by guiding client company in selection of drug packaging
facilities in China, enabling new products to be packaged and sold in country.
 100% customer satisfaction achieved by consulting with and delivering cross-functional technical and business
solutions to clients across two continents.
Sotio, LLC - Boston, MA
Jan 2014 – Sep 2014
Fully integrated global biotech company to develop the next generation of Active Cellular Immunotherapy
(ACI)/personalized medicine.
Director of Manufacturing (US)
Serve as head of manufacturing division for Sotio in US. Responsible for developing manufacturing strategies to
position Sotio in the US market. Advised executive team on critical planning issues.
 Designed, planned and led team to build a $6+ and a $20+ million clinical / small-scale commercial, multi-product
Alan C. Wong, Page 2
cGMP Active Cellular Immunotherapy manufacturing facilities in US & Europe, respectively.
 Developed and build infrastructure including capacity/production planning model to optimize throughput, project
management and tech transfer to strengthen operations.
 Led global CMC team to transfer technology from Czech Republic to US CMO. Audited CMOs & Sotio Czech GMP
facility in terms of quality compliance and technical requirements.
Livzon MabPharm, Inc. – Zhuhai, China
May 2011 – Dec 2013
Fully integrated 7,000 employee pharmaceutical company with R&D, manufacturing, sales, and marketing
capabilities.
Vice President, Manufacturing & Technical Operations
Oversaw manufacturing and technical operations for biotech startup in China. Responsible for developing and
manufacturing oncology Biosimilar and Biobetter for Chinese market and ROW. Set up and led multiple departments
including global supply chain, cell culture fermentation, purification, engineering, fill/finish and quality assurance.
Established & trained Program Managers to run CMC/project teams. Advised executive team on critical planning
issues. Collaborated with US biopharma companies to bring in potential molecules enriching Livzon’s pipeline.
 Planned and coordinated 50+ diverse team of specialists to build $32 million pilot plant / small-scale commercial,
multi-product cGMP Monoclonal Antibody manufacturing facility.
 $200 million annual revenue opportunity generated by building manufacturing division in two years that
incorporated DS/DP manufacturing, purification, engineering, supply chain, and quality assurance functions.
 $500,000 saved by leveraging strategic relationships with US/EU suppliers to negotiate significant cost reduction in
purchase of equipment.
 19%+ market shares gained by helping US SS bioreactor (Abec) and single-use-bioreactor (Xcellerex)
manufacturers to penetrate Chinese Market.
Regeneron – Rensselaer, NY
Biotech company with 2,000 employees and $1 billion in annual revenue.
Aug 2009 – Mar 2011
Director, Supply Chain & External Manufacturing
Directed supply chain planning, external manufacturing, and material management groups with staff of 26. Developed
programs to strengthen strategic partnerships. Led market search, assessment, selection, and engagement of external
partners. Managed all aspects of clinical & commercial parenteral drug product including filling, device development,
labeling, packaging, distribution operations, and process / program improvements. Reviewed CMC documents for US
& EU regulatory filing.
 $1+ billion market penetrated by leveraging internal / external resources to flawlessly managing 10 biologics
programs, ensuring no short supply to market or patients.
 Achieved $500,000 in annual savings by spearheading market search, assessment and selection of qualified CMO to
be brought on board for new clinical manufacturing projects.
 Achieved 10%+ CMO/strategic partner KPI by developing strategic partnership program to enhance performance.
Biogen-Idec, Cambridge, MA
Top 5 global biotech company with 6,000 employees and $6 billion annual revenue.
May 2007 – Aug 2009
Senior Manager, Contract Manufacturing
Recruited to lead five small molecule programs. Developed risk mitigation strategies in support of program / project
requirements. Prepared CMC data for regulatory filing. Audited CMOs in terms of technical requirements and quality
compliance.
 Generated between $100,000-$500,000 in annual cost savings through successful negotiation with Drug Product
CMO to formulate and roll out rebate program.
 Slashed costs by more than $600,000 across API manufacturing through strategic negotiations with CMO.
 Managed small molecule contract manufacturing cGMP programs for oncology and cardiovascular candidates in
Phase I, II, and III across three continents in US, EU, China, and India.
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Pfizer (Wyeth) – Andover, MA
Mar 2003 – May 2007
Major global biopharmaceutical company with 80,000 employees and annual sales exceeding $57 billion.
Manager, Drug Product Contract Manufacturing
Directed all commercial manufacturing for oncology & hemophilia drug products. Accountable for inventory
planning, packaging / distributing finished goods, managing vendor/CMO relationships, troubleshooting processes,
process improvements, and regulatory filing. Supported new product launches.
 Ran/managed Drug Product CMC team including facilitating meeting, preparing agenda & minutes, providing
technical inputs/assessment, and implementation of project activities.
 $300,000 saved per year by taking over project and team to simplify and improve CMO manufacturing operations.
 Cut costs by $500,000 by working with component supplier & CMO to reduce glass vial cosmetic defects.
 Secured 30%+ reduction in drug product manufacturing cycle time by leveraging internal and external resources to
improve operational efficiency, resulting in batch release throughput augmentation.
Takeda (Millennium) – Cambridge, MA
Oct 2001 – Feb 2003
Major global biopharmaceutical company with 30,000 employees and annual sales exceeding $17 billion.
Senior Manager, Product Sourcing
Managed biologics clinical manufacturing cGMP program for pre-clinical, Phases I & II clinical candidates.
Developed $10,000 to $35 million RFP for vendors to bid on projects.
 Led $35 million anti-cancer program project team in developing and implementing outsourcing strategies across
global complex supply chain with CMOs located across three continents.
 Supported $10s of millions of dollars in potential clinical program investments by developing in-depth business and
strategic analyses covering breakeven computation, projected ROIs, revenue forecast, and capability of
CROs/CMOs.
 Collaborated with Clinical Research/Operations in generating supply & demand forecasts, patient accrual rate and
dosing regimen.
 Audited CMOs in terms of technical requirements and quality compliance.
Bristol-Myers Squibb – Syracuse, NY
Oct 1994 – Oct 2001
Major global biopharmaceutical company with 28,000 employees and annual sales exceeding $16 billion.
Development Engineer, Pilot Plant Operations
Oversaw ß-lactam fermentation pilot plant with staff of 8. Developed action plans and project timelines. Supported
projects from Phase I to commercial (5,000 – 200,000 L).
 Boosted productivity by 8%+ and cut operating expenses by $50,000+ per year by reducing energy consumption and
sterilization time, while improving cell nutrient uptake across plant operations.
 Obtained $2 million annual savings through reengineering and continuous improvement of manufacturing process.
 Reduced contamination rate by 30%+ by troubleshooting and improving laboratory, pilot plant, and production antitumor processes.
 Provided ad hoc and in depth data/processes analyses to senior management for GO versus NO GO decisions
making.
Additional Positions:
Merck (Schering-Plough), Union, NJ: Chemical Engineer
Enron (Genex), Gaithersburg, MD: Process Engineer
University of Rochester, Rochester, NY: Research Scientist
EDUCATION
 M.B.A. in Finance, Le Moyne College, Syracuse, NY
 B.S. in Chemical Engineering, University of Rochester, Rochester, NY
 A.S. in Engineering Science, Monroe Community College, Rochester, NY