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.

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.

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.

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.

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.

- 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.

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.