Michele Ho has over 10 years of experience in materials and project management. She has worked at Intarcia Therapeutics as their Materials Manager since 2010 where she directed materials management activities and ensured clinical supplies. Prior to that, she held project management roles at Alza Corporation and Santa Cruz Biotechnology where she supported various development projects. She is seeking a new career opportunity in materials/supplier/project management.

1. Michele Ho
501 Murphy Ranch Road, # 254, Milipitas, CA 95035 * 510-366-0852 * masaki11@gmail.com
Objective:
I am seeking a career in Materials/Supplier/Project Management, where I can utilize my skills and knowledge to help
expand the continued success of a dynamic company.
Professional Experience:
Intarcia Therapeutics, Inc., Hayward, CA
Materials Manager
May 2010 – Present
● Directed activities and supervised Materials Management group
● Assisted in management and planning of clinical manufacturing timelines and daily activities; Helped to
ascertain clinical supplies including over-encapsulation, packaging, and labeling
● Created inventory management system to track and manage logistics of over 300 raw materials (API,
excipients and floorstock), intermediates, and final product
● Managed manufacturing flow of intermediates through 30 unit operations
● Controlled and executed flow of materials / final product from vendor initiation, procurement, receipt,
sampling, testing, and approval to dispensing and shipping in accordance with cGMPs, product requirements,
material specifications, and vendor assessment policy
● Partnered with cross functional groups including Manufacturing, CMC, QA, Product Development, Clinical,
Non-Clinical, Regulatory, and Accounting/Finance to ensure proper controls and to resolve issues related to
approval of raw materials and intermediates
● Setup material location system and managed warehouse operations to ensure GMP compliance and proper
placement of safe chemicals, caustics, flammables, rejects, quarantine, and retain items
● Initiated and managed global harmonization training of new Safety Data Sheets
● Assisted in identifying and managing qualification & implementation of the inventory and manufacturing
modules of the new ERP system
● Established planned estimates for required warehouse and cleanroom space for commercial buildout
including 5K, 20K, 80K, and 2M system forecasts
● Planned and managed building and moving of temporary warehouse space, dispensing/sampling rooms, and
warehouse vestibules of incoming material receipt for PAI readiness
● Configured and executed response to internal warehouse audit including incoming receipt, dispensing,
sampling, and storage of materials
● Attended over 10 vendor audits as the SME
● Represented as the supply chain and warehouse lead during state inspection, QP audit, CE Mark inspection,
ISO 13485 audit, and partner audit
● Developed vendor relationships to guarantee continual quality of materials and to resolve issues pertaining to
material orders, production issues, and forecasts; managed multi-functional discussions to determine vendor
capability of scale-up and commercial capacity from 100K to 2M device component parts per year
● Sourced and managed secondary suppliers, custom compendial chemicals and contract manufacturers;
Initiated, evaluated, and managed material production activities with vendor to meet project timelines
● Implemented NDAs, MSAs, and supply agreements with vendors; Negotiated pricing agreements and
successfully reduced cost of cleanroom supplies by 20%.
● Established yearly budget with forecasts through 2M launch and COGS relating to the manufacturing of
materials, supplies, and production equipment parts
● Identified critical raw materials for supplier qualification and process validation.
● Updated corresponding GMP documentation for process validation, including specifications and ex ecution of
change requests
● Created and revised specifications for raw materials according to product and compendial requirements
● Wrote and reviewed sections for NDA filing
● Executed deviations and CAPAs; Created/revised SOPs to establish compliance

2. Maxreal, San Ramon, CA
Loan Agent
May 2008 – May 2010
Alza Corporation, Mountain View CA
Johnson & Johnson
March 2002 – October 2007
Project Manager
March 2007 – October 2007
● Created new CMC Portfolio and Project Management team in support of the development of projects on the
West Coast
● Integrated and managed West Coast ChemPharm R&D resources and budget by partnering with cross-
functional groups within the organization and other R&D groups
● Drafted business plan forecasts and quarterly updates out to 6 quarters on a deliverables level including cost
to launch for all West Coast development projects and support activities
● Developed, executed, and monitored multiple project plans across various drug delivery platforms including
oral, transdermal, drug-device, etc.
● Partnered with Finance and R&D Controllers to harmonize alignment and develop alternative plans to fit
within allocated budgets and next decision cost points
● Rolled-out new time reporting application involving setup of new charge numbers and training across
functions
● Implemented new strategies and analyzed time reporting versus forecasted demand to develop a more
accurate business model and to aid in the evolution of the West Coast project management group
● Assembled Work Plan and Cost Estimates for Due Diligence and Life-cycle management projects
Technical Development Coordinator II - III
March 2002 – March 2007
● Supported development projects from feasibility through technology transfer which utilize oral, transdermal,
and implant controlled release systems
● Drove clinical production activities to meet project timelines
● Aided in drafting and tracking raw material files and specifications, clinical production records, intermediate
and finished product specifications
● Communicated with vendors to ascertain proper selection and adequate supply of experimental and GMP
materials for clinical production; ensured materials were internally approved for clinical use
● Managed vendor/lab contract agreements
● Interacted with manufacturer and broker to import active drugs and biologics; familiar with import/export
policies and procedures
● Wrote and revised technical documents, participated in writing and assembling of the CMC sections of
regulatory filings
● Analyzed, reviewed, recommended, and implemented process improvements; revised SOPs
● Supervised, trained, and mentored employees, provided performance feedbacks and career guidance
Santa Cruz Biotechnology, Santa Cruz, CA
Product Development / Technical Support
April 1999 – March 2002
● Determined which target proteins to make antibodies
● Designed peptide and recombinant epitope sequences
● Graded WB gels and wrote datasheets for new products
● Searched for well-characterized monocloncal antibodies to license
● Experience with discussing terms and conditions of agreements in technology transfer
● Supervised and trained part-time employees in the technical support department
● Provided technical support to domestic customers and abroad through product information, antibody usage,
recommendations, and product substitutions
● Familiar with Western Blots, Immunoprecipitation, Immunohistochemistry, EMSA, Flow Cytometry, and
Kinase Assay procedures

3. Additional Experience
● Computer skills: MS (Word, Excel, Powerpoint, Access, Project), OPX2, Word Perfect 5.1, Appleworks,
Filemaker Pro, and QAD-based inventory management and procurement system
● Lab experience: Cellular and Molecular Biology, Development, Physiology, and Genetics
● Languages: Cantonese and Mandarin (fluent), French (proficient)
● GMP ISO-13485
● PMP Project Management
● Forklift Certified
Education
● University of California, Santa Cruz, BA in Biology, 2000