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 data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles. Complete testing in a timely and appropriate manner.May maintain inventory/supplies necessary to conduct routine testing.Performs equipment maintenance and calibrations as required.Perform aseptic sampling, visual inspection, gowning and working in clean room areas.Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems. Investigate and write exception (e.g. deviations and OOS) documents.Provide training to junior staff.May perform other duties as assigned.

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 investigate if necessary purchases received with vendors.Provide quality recommendations to management for effective process flow and best practices in contamination control.

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 and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.Used sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Performed assays requiring precise analytical skills and understanding of biology and chemistry principles.Completed all testing, including special project / protocol testing in a timely and appropriate manner.Initiated and obtained applicable approval for test requests.Maintained inventory / supplies necessary to conduct routine testingFollowed continuous improvement practices (QLP, 5S, LEAN, etc.)Performed equipment maintenance and calibrations as required.Served as mentor to Quality Control Analyst (QCA) I positions. Provided training and work direction for QCA I positions as required.Maintained data integrity and ensured compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Performed release functions in LIMS or other computerized systems.Wrote exception documentations.Participated in functional efforts involving teams, which impacted production, increase efficiency, solve problems, generate cost savings and improve quality.Performed laboratory and manufacturing audits as required. Audited and updated, as required, plant SOPs.Performed other laboratory duties as assigned.

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 commercialization. Raw material documents reviewed per regulatory requirements and updating all regulatory systems including Optiva. Utilized Optiva to enter raw material regulatory information and review against certified documents to make available pertinent information required for product flow. Ensured all quants and IL’s met regulatory requirements and customer needs. Multiple task-related projects and support completed within customer timeline in an efficient manner.

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 concentration on mainly pivotal clinical drug products within crucial product business processes. • 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 directly to the Quality Control Director. Critical stability samples as part of their stability protocols were initiated and analyzed at key timepoints to validate product integrity, providing certificate of analysis. Novel bacteriophage products are critical to treatment of antibiotic-resistant strains of PA (Pseud. aeruginosa) in CF (cystic fibrosis) patients.• 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.• Quarantined/released key incoming raw materials used in manufacture of novel bacteriophage products.• Prepared and sent out critical samples to contract testing lab for sterility tests as part of product qualification initiatives.• Partnered/collaborated with Manufacturing to train on key cleanroom best practices as guided within company procedures.• Recommended new methodologies for QC tests on DS and DP for efficiencies within the process such as in-house sterility, microbiology.• Analysis and testing of QC analytical methods on DS and DP samples: Osmolality, protein concentration, pH, visual inspection, DNA/RNA exclusion, RT-PCR/qPCR, SDS-Page, phage plaque titer assay, endotoxin, RP-HPLC, etc.• Ensured all documentations followed key GDP/GMP guidelines within lab notebooks.• Assisted and ensured past QC files were organized for archival to outsourced partner.

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 guidelines set forth by local and national governmental entities in the manufacture of drug substance and drug product.• 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 data access when required to perform trending or investigative purposes.• Audited past and present clinical lot batches for lot disposition and timely closure based on timeline. • Initiated and investigated nonconformance due to environmental excursions to determine the root cause.• Responsible for general microbiological support including Gram stain, endotoxin, qPCR, mycoplasma, bioburden, sterility.• Supported EMPQ activities for new manufacturing facility build-out.• Maintain current GMP facility and lab for testing and process activities.

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 in-process and final product testing needs of novel immunotherapeutic Drug Substance and Drug Product following all applicable FDA, ICH regulated cGMP standards as well as OSHA Safety regulations to meet the critical needs of the business. • 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.• Performed Gram stain on final product patient samples to ensure no microbial contamination.• Performed ELISA (Enzyme Linked Immunosorbent Assay) ID test on final product patient samples to determine presence of Sipuleucel-T via PA2024 antigen (fusion protein containing prostatic acid phosphatase and GM-CSF). • Performed Kinetic-Chromogenic Endotoxin test (LAL) on final product patient samples to ensure the safety of the product manufactured. • Utilized Gen5 and WinKQCL softwares to perform assays and resolved troubleshooting issues.• Train-the-Trainer certified.• Maintained and audited all applicable laboratory documents and training records according to cGMP guidelines.• Supported the laboratory investigation report process of out-of-specification (OOS) and invalid assays.• Responsible in maintaining and upkeep of QC laboratory in a GMP state.

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 company business needs.• 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 regulatory requirements and internal guidelines.• 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.• Utilized key Quality Systems such as LIMS, TrackWise, JDE, and BPLM to prepare, issue, and verify documents and reports as defined by the area.• Six Sigma Yellow Belt certified.• Supported EBM (Electronic Batch Management) in providing best documentation practices for optimization within EBM for each Manufacturing process.• Demonstrated ability to operate in a dynamic, cross-functional environment with knowledge of biotech manufacturing theories and processes.

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 methodologies to meet critical business needs.• 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.• Train-the-trainer certified.• Lean Six Sigma yellow belt certified.• Performed Gram stain and examined morphology of microbial isolates.• Performed growth promotion testing of raw materials and process related samples: various media including TSA, SBA, TSB, BacT/Alert bottles.• Supported the B&F organism study for BacT system.• Analyzed and reviewed results in LIMS.• Initiated Laboratory Investigations for EM excursions and utilized the 5M analysis methodology for root cause investigations.• Initiated and closed Exception Reports for product related investigations.• Responsible for writing and closing Quality Quarterly EM Microbial report by collaborating with multiple departments.• Organized, managed, and archived training documents.• Audited batch records for data related to investigation purposes.• Utilized aseptic technique in BSC hood ISO 5 environment.• Consistently met or exceeded process timelines for meeting corporate goals.• Performed Surface Air System instrument process validation.• Performed facility high purified water testing utilizing Bioburden, Total Organic Carbon, and Conductivity.• Supported the implementation of 5S in the laboratory.

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, Fluorometer, and FT-IR methodologies in a FDA regulated facility. Followed all applicable cGMP and GLP guidelines with local SOP's, methods, and USP. Followed all applicable OSHA Safety guidelines to meet company business needs. Investigated OOS results by writing investigation reports for justification and closure. • 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 separation of conjugate species to free dye. Then performed trial pools on the conjugate species for final product formulation and bulk inventory. Supported Ab and dye preparations in dialysis for conjugation purposes. Dye preparation experiment/investigation was conducted due to out of tolerance situation. Process compliance guidelines with FDA and ISO were followed as appropriate. Utilized Kaizen and six sigma tools for process improvement.

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 included specification/lot release, stability, and special studies Drug Product samples utilizing various scientific methodologies. Test methods utilized were Spectrophotometry, UV/Vis absorbance, Bradford protein assay, (Affinity *Protein-A*, RP- *Reversed-Phase*, AEX- *Anion-Exchange*, SE- *Size Exclusion*) HPLC, Gel-clot LAL, Kinetic-Turbidimetric LAL, pH, Conductivity, Density, Refractometry, Osmolality, TOC, Environmental Monitoring. Drug Product lot release testing utilized Spectrophotometry, UV/Vis absorbance and Gel-clot LAL methods.Adhered to all applicable FDA, ICH, and Safety regulated guidelines to meet company business needs.• 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.• Responsible for investigating Out-of-Spec test results. • Responsible for laboratory equipment and materials upkeep/inventory.• Operational Excellence• Organized and managed training documents.• Audited laboratory notebooks and controlled forms to ensure completeness for upcoming FDA inspections.• Designated as area Safety representative - received multiple individual and departmental Safety awards.• Revised procedures as well as updated and created new forms for new clinical products.

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 utilizing ion-exchange chromatography, UF/DF, other separation techniques, and utilizing various scientific principles in a FDA regulated facility. Produced CHO Mammalian recombinant Cell Culture Drug Substance with roller bottle processing and harvest. All applicable local OSHA Safety, FDA, ICH guidelines were strictly adhered to.• 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. • In-Process Environmental Monitoring.• Analytical methods utilized such as pH, Conductivity, Cell counting using Hemocytometer under Light Microscope for cell viability, Blood Gas Analyzer (BGA) to monitor cells.• Organized and managed training documents.• Revised and updated process related documentation forms.

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 in a highly regulated facility. Affinity and ion-exchange chromatography separation techniques and aseptic technique were utilized for critical process steps. • 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.• Designated as area Safety representative.

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