Michael Choy Email & Phone Number

United States

- Providing quality leadership and oversight of 3 Contract Manufacturing Organizations (CMOs) in support of Drug Product (DP) and Final Packaged Product (FPP) operations- Driving internal and external CMO deviations, CAPAs, and change controls to ensure quality issues are thoroughly investigated and documented- Leading QA review of Process Performance.

- Coordinated external activities at 4 CTLs for release testing, stability programs, OOS/OOT investigations, deviations, reference standards, method validations, and technical transfers- Managed internal QC deviations, CAPAs, and change controls related to method revisions, specifications, batch records, and Quality SOPs - Determined testing priorities at.

Redwood City, CA

- Oversaw sample management, sampling plans, testing timelines, incoming/outgoing shipments, and temperature monitoring at CTLs - Conducted statistical analysis of release and stability data using JMP to set release and shelf life specifications per ICH Q1E guidelines- Analyzed chromatograms, raw data, and notebook pages to support OOS, OOT, and laboratory.

Thousand Oaks, CA

- Responsible for product disposition, batch record review and release, deviation management, and CAPAs for the commercial BAXJECT III Drug Product operation - Reduced FDP product release cycle times by 50% in 9 months by coordinating with manufacturing, quality, and supply chain to streamline the production schedule, implement on-the-floor batch record.

- Achieved a 25% reduction of method transfer cycle times by leading a team of 5 colleagues in assessing current performance, creating a value stream map, and identifying bottlenecks- Consolidated the method transfer process by using ICH guidelines to evaluate 50 method transfers, and utilized Six Sigma methodology to create a future state process map

Emeryville, CA

- Developed a centralized database that captures all projects, resources, and tasks within GMP Manufacturing, Engineering, MS&T, Supply Chain, Quality, and Regulatory that generates a 12-month resource forecasting tool which quantifies resource availability to enhance project planning and budgeting- Constructed a SOP and cross-functional flowchart that.

Northridge, CA

I worked in the Drug Delivery Systems branch, and conducted analysis on finished product inhalable drugs to ensure efficient time to market. I quantified content, active pharmaceutical ingredients, impurities, and medication delivery of finished products while implementing GDP/GLP procedures and adhering to FDA regulations.My responsibilities also included.

Cambridge, MA

I synthesized an alpha-keto amide and studied the degradation of this compound under oxidative conditions. HPLC, LCMS, and NMR were used to characterize and analyze my compounds. In addition, I helped expedite future projects by implement new procedures to prevent the degradation of compounds.

San Diego, CA

Hands-on drug discovery research. I performed multi-step synthesis reactions to synthesize a library of 30 new compounds that initiated early stage drug discovery projects. My compounds were tested for pharmacokinetics and drug metabolism to identify lead pharmacophores

Walnut Creek, CA

Demonstrated and presented the use of Cutco products to potential customers, negotiated transactions, and promoted business growth by $5k. Established a new clientele list of 25 customers

Masters Of Bioscience (Mbs), Bioprocessing

Activities and Societies: Parenteral Drug Association (PDA) - KGI Student Chapter Officer

B.S., Chemistry

Activities and Societies: Smaug Ultimate Frisbee, UCLA UniCamp