Anthony Ko Email & Phone Number

Santa Ana, California, US

Assist management in coordination of day to day QC activities. Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment. Use sophisticated laboratory instrumentation and computer systems to collect and record.

Newbury Park, CA, US

Assist start-up functional activities based on local and federal governmental entities. Review and recommend quality document drafts and revisions for facility and equipment qualifications, IOQ & EMPQ. Prepare, draft, review, and submit quotes and purchase orders required for departmental functional materials and equipment. Receive, inspect, and.

Tokyo, JP

Conducted and performed a wide range of biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) and medical devices through all stages of the manufacturing process from incoming raw materials to finished goods, and included environmental monitoring programs.Regularly performed HPLC.Conducted critical biological, chemical.

Chatsworth, California, US

Supported the functional regulatory requirements for consumer product businesses including OTC cosmetic products in providing customer support within a contract manufacturing setting. Act as liaison support between R&D, customers, suppliers, and manufacturers to provide regulatory requirement needs to assess and finalize products in development and.

Thousand Oaks, CA, US

• Supported the Clinical Quality Control HTL/RTT and HPLC laboratories that follows cGMP's, FDA guidelines, and compliance regulations. Testing support for DS, DP, and stability time-point samples for protein.
• Utilized SoloVPE variable pathlength protein concentration method.
• Worked in teams to support HPLC group and providing critical protein concentration for HPLC standards and controls.
• Utilized LMES, electronic lab notebook that complies with 21 CFR Part 11 and fully integrates the LIMS-sample manager for data retrieval.
• Laboratory upkeep in a GMP audit ready-state.
• Support QC reference standard inventory.

Los Angeles, California, US

• Supported critical Quality Control initiatives to test several novel bacteriophage drug products and drug substances in order to include in important IND filings to FDA and key governmental entities, while reporting.
• Prepared formulations of differing concentrations of bacteriophage DS/DP, collaborating with QC team to send out to contract testing lab.
• Tested DS/DP stability samples to provide COA and assurance of product integrity.
• Partnered/collaborated with key R&D Scientists to transfer ELISA analytical method into QC for routine testing.
• Responsible for writing ELISA method to include in IND filing and qualify product parameters.
• Ensured key instruments/materials were in GMP/GLP ready state and functional as required.

Culver City, CA, US

• Supported the microbiological testing needs of clinical phase novel immunotherapeutics that utilize the Natural Killer (NK) cell platform technologies. Performed under and adhered to strict cGMP regulations and.
• Performed environmental monitoring of manufacturing area to support manufacturing using aseptic technique and required protocol.
• Reviewed required data in support of drug substance and drug product against various methodologies.
• Aseptic gowning ISO 5 and ISO 7 qualified.
• Supported departmental and company needs in compiling past and present data representing clinical lot batches to organize onto excel spreadsheets and streamline the data documentation process. Ensures feasibility of.
• Audited past and present clinical lot batches for lot disposition and timely closure based on timeline.

Seal Beach, CA, US

• On June 29, 2017, Valeant Pharmaceuticals completed the sale of Dendreon Pharmaceuticals to Sanpower Group.On February 20, 2015, Dendreon became a wholly owned subsidiary of Valeant Pharmaceuticals.Supported the.
• Analyzed in-process and final product patient samples utilizing Beckman-Coulter FC500 Flow Cytometry method.
• Analyzed in-process and final product patient samples utilizing Beckman-Coulter AcT5 diff. to determine CBC (Complete Blood Count), WBC (White Blood Cell) count being the most important.
• Utilized Trypan Blue exclusion method to determine Cell Count for Cell Viability using Zeiss Axiovert microscope.
• WBC Total Nucleated Cell (TNC) determination for BDS65 was crucial for the amount of antigen addition required.
• Utilized ERPLx system for TNC entry for antigen calculation.

Bridgewater, NJ, US

On June 29, 2017, Valeant Pharmaceuticals completed the sale of Dendreon Pharmaceuticals to Sanpower Group.On February 20, 2015, Dendreon became a wholly owned subsidiary of Valeant Pharmaceuticals.

Tokyo, JP, JP

On June 3, 2016, Baxalta was acquired by Shire to become the world's global leader in rare diseases.

Illinois, US

• On July 1, 2015, Baxalta became a spin-off biopharmaceutical company of Baxter International. On June 3, 2016, Baxalta was acquired by Shire to become the world's global leader in rare diseases.
• Batch records were reviewed and submitted for release to meet target deadlines following all applicable local and global procedures that adhere to FDA, ICH and regulatory guidelines.
• Initiated and closed Quality investigations related to product Non-Conformances utilizing the 5 Whys and 5M analysis for root cause investigations.
• Supported EBM (Electronic Batch Management) in providing best documentation practices for optimization within EBM for each Manufacturing process.

Deerfield, Illinois, US

• Conducted reviews of documentation and reports for conformance to procedures, protocols and regulatory requirements supporting plasma-based Bulk Manufacturing.Adhered to all OSHA Safety, FDA, ICH guidelines to meet.
• Responsible for reviewing pertinent documents, records and reports such as Manufacturing Batch Records and forms against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on.
• Identified areas of non-conformance during production and informed management by drafting observations for Non-Conformance Events/CAPA investigation purposes.
• Initiated and closed Quality investigations related to product Non-Conformances utilizing the 5 Whys and 5M analysis for root cause investigations.
• Identified potential compliance risks on the manufacturing floor or documentation and worked closely with manufacturing to resolve issues.
• Demonstrated strong interpersonal skills and great attention to detail with good team player and problem solving capabilities.

Seal Beach, CA, US

• Supported the environmental monitoring and microbiological needs of novel immunotherapeutic drug production following applicable cGMP FDA, ICH guidelines, compliance, OSHA Safety guidelines and various scientific.
• New facility start-up, Commercial process validation, and capacity studies.
• Performed routine and in-process environmental monitoring testing.
• ISO 5 and ISO 7 aseptic gowning qualified.
• Performed sterility testing utilizing BacT 3D Alert system.
• Investigated microbial and material Exception Reports to determine root cause for closure.

• Tested Bulk and Finished Goods for OTC actives and preservatives such as Salicylic Acid, Avobenzone, Octisalate, Coal Tar and Phenoxyethanol, Methylisothiazolinone etc. via various laboratory techniques such as HPLC.
• Audited laboratory notebooks to ensure completeness for FDA inspection purposes.
• HPLC Instrument (Agilent 1100/1200) troubleshooting performed for root cause investigation needs.
• Utilized Chromeleon to analyze chromatography runs.

Waltham, MA, US

Supported the production of conjugated antibodies (Abs) and small molecules with specific dyes to maintain company's productivity and to complete backorders on a daily basis. The Abs were conjugated to dyes such as PE and APC while small molecules were conjugated to FITC, Biotin, Pac Orange, and Alexa Fluor. Utilized size exclusion chromatography for.

Thousand Oaks, CA, US

• MAS (Manufacturing Analytical Services):Involved with real-time testing of critical in-process Drug Substance Commercial and Clinical Manufacturing samples in a multi-commercial product facility. Other sample types.
• Analyzed and approved data results in LIMS.
• Method transfer of Affinity HPLC platform method for multiple Clinical drug products from originating site.
• Method transfer of Spectrophotometry method for Clinical drug product from originating site.
• Recognized as Spectrophotometry methods and equipment subject matter expert.
• Training of staff in Spectrophotometry, HPLC, and LAL methods.

Thousand Oaks, CA, US

• Involved in a multi-commercial product facility at Amgen's corporate headquarters in Thousand Oaks, CA. Responsibilities involved Commercial Purification of E. Coli bacterial recombinant protein Drug Substance.
• Gaulin Homogenizer for cell lysis and Sharples Centrifuge for separation of cell suspension.
• Clean-In-Place (CIP) and Steam-In-Place (SIP) of equipment to ensure sterility and/or sanitization.
• Aseptic laminar process for final Diafiltered Media (DFM) and Conditioned Media sampling for sample submissions.
• Aseptic gowning ISO 5 and ISO 7.
• Designated as the Cell Culture area analytical methods and equipment expert.

Deerfield, Illinois, US

• Involved with Commercial Purification of CHO Mammalian recombinant protein therapeutic Drug Substance in support of hemophilia therapeutic following all applicable FDA, ICH, Safety guidelines and scientific principles.
• Clean-In-Place (CIP) and Steam-In-Place (SIP) of equipment.
• Chromatography Column packing activities.
• In-Process Environmental Monitoring.
• Analytical methods for pH and Conductivity utilized.
• Organized and managed training documents.

Thousand Oaks, CA, US

Supporting Clinical Manufacturing Formulation and Filling operations of Drug Products following various procedures abiding cGMP, FDA, ICH, ISO, and Safety EHS guidelines.

Bachelor’S Degree, Biological Sciences

High School Diploma