Eva A. Email & Phone Number

Seattle, Washington, United States

Provide strategic planning to establish GMP QC function to ensure quality in product life cycle Identify gaps, design collaborative solutions and provide guidance for laboratory efficiencies and improvements.Establish expectations, develop metrics and key performance indicators to monitor performance and ongoing activitiesHire, build and maintain expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities as required.Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and company milestones are achieved.

Redwood City, California, United States

Provide technical expertise and direction for analytical and microbiology groups to ensure success of GMP Quality Control functions.Customer facing, as a SME, to provide strategic plan for pre-clincal IND submission.Develop phase appropriate analytical and microbial methods qualification/validation for clients in a timely manner.Develop and maintain strategic plan, including outsourced activities and business continuity, to ensure cGMP testing needs are met.Responsible for QC audit and inspection readiness, including support and provide expertise and preparation of responses to observations and ensuring response CAPAs are effective. Establish expectations,monitor performance and ongoing activities; hire, build and maintain expertise in the QC organization, through development of staff to ensure that the QC organization supports manufacturing operations and analytical development activities as required.Collaborate with Quality Assurance, Manufacturing, Material Management, and other functions to ensure internal timelines, testing TAT and team milestones are achieved.

Seattle Wa

Provide strategic and scientific roadmap for quality control program to support company’s goals and milestones. Responsible for implementing and maintaining quality control systems and overseeing QC staff. Work with technical staff and cross-function team to develop and implement Spec, standards, analytical testing methods and procedures for incoming, in-process, finish product testing and post-launch monitoring. Evaluate the compliance of next generation sequencing related products to established specifications following ICH/CAP/FDA guideline. Establish stability program for reagent shelf-life claims. Ensure that all the tasks are properly executed, timeline, and applicable GxP regulations are met. Ensure that the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable test results. Lead NC, CAPA investigations. Hire, develop and train an agile Quality Control team capable of implementing Quality Control. Established QC strategy for new product introduction portfolio

Bothell, Washington

Recruited by Bothell site director to lead a newly formed QC department: oversee all final QC release testing and stability study programs for proprietary small molecule chemical reagents and oligonucleotides used in PCR based molecular diagnostic kits; evaluate and implement process improvements; ensure proper documentation through product life cycle; troubleshooting, CAPA investigation, and analytical test method development and validation. - Oversee all final QC release testing and stability study programs for proprietary chemical reagents and oligonucleotides used in PCR based molecular diagnostic kits.- Evaluate and implement process improvements; ensure proper documentation through product life cycle; troubleshooting, and analytical test method development and validation. - Implemented stability study program for proprietary chemical reagents (over 50 products) within first year; this effort led to the proper storage conditions, identification, and product spec determination.- Established QC analytical methods to characterize multiplexing assay components. - Identified critical parameters for streamline work flow and a compliant quality system. - Implemented SPC (Statistical Process Control) to monitor instrument performance and lot-to-lot variation.- Developed analytical tools for troubleshooting components in final kit assembly, which led to the understanding of the key variables in formulation, critical to the kit stability. By changing the formulation, we were able to extend an additional 6 months and eliminate the need of the 4oC shipping requirement.

Seattle

- Responsible for analytical method development for upstream and downstream in-process characterization as well as high-throughput analytical methods, development, and validation.- Provided analytical service to support other departmental activities.- Provided timely analytical service and data analysis for product characterization for Research and Process Development departments which led to improved purification processes- Developed high-throughput analytical methods which led to the identification of critical parameters for cell growth and viral infection condition and resulted in more than 50% increase of protein yield.

- Strategic planning and oversight of internal R&D development- Design experimental protocol for biomarker discovery and assay development- Manage lab operation and supervision of research team as well as contractors- IP portfolio evaluation, patent application drafting, and prosecution- Responsible for biomarker discovery and validation including development of ELISA kits and a quantitative LC/MS/MS based MRM (Multiple Reaction Monitoring) assay for early cancer detection; explored and evaluated new technologies for in-licensing opportunities; set research direction and clinical utility application for business development and commercialization of invention- Initiated prostate and colorectal cancer biomarkers development programs. A set of biomarkers were identified, and two patents were filed which enhanced company’s IP position- Designed ELISA assay based on the biomarkers identified through LC-MS-MS- Validated biomarkers using mass spectrometry and ELISA in different cell lines and biological fluids

Los Angeles Metropolitan Area

- Strategic planning for import/export natural product to China and Asia- Evaluation for new product and new product registration with FDA- Set up an analytical lab for evaluation of product components- Established SOP for new products manufacturing- Obtained class I and class II medical device clearance with FDA

Seattle, Washington, United States

Responsible for lateral-flow immunochromatographic based point-of-care (POC)device development for osteoporosis detection, including ELISA assay design and optimization, incoming raw materail QC and in-process QC monitoring implementation, and manufacturing process control documentation.