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@fluxergy.com
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Shrin Kuo is listed as Program/Project Management | Product Development | Strategy | Innovation at Seegene USA, based in Yorba Linda, California, United States. AeroLeads shows a work email signal at fluxergy.com, phone signal with area code 760, and a matched LinkedIn profile for Shrin Kuo.
Shrin Kuo previously worked as Senior Program Manager at Seegene Usa and Associate Director of Immunoassay Development at Fluxergy. Shrin Kuo holds Mba, Product Design And Development | Marketing | Strategy | Innovation from University Of California, San Diego - Rady School Of Management.
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Program Leader with over a decade of experience in leading, educating, and executing the development, manufacturing, and commercialization of custom, user-centric, immunoassay rapid diagnostics for a multitude of markets (biomedical, veterinary, food-safety, consumer, and biodefense) with the goal of making laboratory diagnostics easier and more accessible to various end users. During my career, I have managed and led multiple teams in the successful contract development and commercialization of rapid diagnostic tests at Fluxergy and DCN Diagnostics as well as guided multiple clients from strategy to execution with sustainable results in the Life Sciences sector as a Project Management Consultant with Integrated Project Management (IPM). Currently I am a Senior Program Manager at Seegene USA leading cross functional teams in making molecular diagnostics more accessible.
Listed skills include Biochemistry, Life Sciences, Microbiology, Elisa, and 39 others.
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A career timeline built from the work history available for this profile.
Irvine, California, Us
Leading cross-functional teams in various programs from ideation to commercialization for on-time delivery of milestones to final release. Establish program management approach, processes, and best practice within the PMO team and across the entire Seegene USA organization.
Irvine, California, Us
WHAT I DID:As the Assoc. Dir. of Immunoassay Development, I led multiple cross-functional teams in IVD design, development, validation, and transfer activities under FDA, IVDD/IVDR, and ISO13485 requirements. Responsible for aligning the strategic direction of the assay development team with the overall business strategy while leveraging innovation in the development and commercialization of new, high-performance, and cost-optimized assays. In addition to maintaining the budget, timeline and resources needed, worked with marketing, quality, manufacturing, regulatory and engineering teams to drive continuous improvements.ACCOMPLISHMENTS:- Established an Immunoassay R&D and Production Department from ground up, including hiring, lab design and construction, procurement of all reagents and equipment, education of staff.- Drafted and implemented initial design control and QMS documentation including all IQ,OQ,PQ requirements for equipment prior to a quality department being established. Documentation created and processes outlined became foundation for QMS system for assay development. Created and monitored all documentation for DHF requirements on all immunoassay projects.- Led multiple projects within the Fluxergy organization related to immunoassays. Project ranged from adaptation of the Fluxergy Analyzer and Card, education across all departments on the concept, market, and development pathway of LFA, education of design control process and the regulatory requirements of IVD assays, and assay development project management. - Assisted and advise production and automation team on manufacturing operations, documentation, and concepts in LFA manufacturing.- Completed feasibility and optimization of a CoVID-19 IgG/IgM fluorescent assay prior to shift in company strategy.- Establish raw materials network of Immunoassay development and manufacturing supplies.
Burr Ridge, Il, Us
WHAT I DID:As a Project Management Consultant, I was accountable for overall project implementation, and worked with clients in the life sciences industry, including pharmaceutical, biotechnology, and medical devices. As a leader I integrated on-site into the client environment to effectively lead project teams while building positive professional relationships with clients and associates. Once integrated, I:- Defined project objectives, requirements, and assumptions necessary to structure a project/program.- Plan, schedule, and control project activities to fulfill objectives and satisfy project requirements.- Develop and drive integrated project plans, aligning project tactics with project strategy.- Establish, maintain, and lead high performance project teams, serving as the project advocate within the client organization. Lead, coordinate, facilitate, and motivate all associated project resources to gain alignment on project goals and deliverables.- Lead risk management within project teams, ensuring risks have appropriate mitigation and contingency plans.- Manage projects within established scope, schedule, and budget while meeting and exceeding project management standards.- Develop and document high-level strategies for accomplishing specific project objectives.- Facilitate and lead effective project meetings, manage change and conflict, and develop resource planning estimates to manage project workload and productivity.- Support project management team members to ensure success of projects while maintaining customer service focus.ACCOMPLISHMENTS/PROJECTS:- Led a diverse team including operations, quality, regulatory, marketing, and supply chain to create an effective and playbook for evaluating and selecting compound pharmacies to fill medical device product with drug of choice.- Led an international team including marketing, operations, manufacturing, and finance on a SKU rationalization project to select products for end of life.
Carlsbad, California, Us
WHAT I DID: As a Program Manager | Senior Scientist, I have led multiple cross-functional teams of scientists and engineers assisting clients in the development of the entire rapid diagnostic test, from concept to commercialization, while maintaining the budget and timelines required. As a Product Manager, I performed the market research, developed and presented various commercialization plans to potential investors, and assisted in grant submissions of a novel diagnostic assay.ACCOMPLISHMENTS:- The successful development and transfer to manufacturing of three novel immunoassays. These projects consist of: A gold qualitative and fluorescent quantitative assay for novel cardiac marker, a multiplexed quantitative fluorescent assay for liver damage, and a cellulose nanobead based (CNB) infectious disease assay for women's health.- Led multiple feasibility assay development projects consisting of both quantitative and qualitative tests using multiple labels, sample types, and reader integrations.- Consulted various companies on project management, risk assessment, market evaluations, verification and validation, and regulatory submissions.- Performed all program manager functions for CDMO services provided to clients while improving development tasks, workflow and performance.- Created and implemented documentation necessary for DHF requirements and transfer to manufacturing for several assays.- Conducted audits of several manufactures to successfully troubleshoot manufacturing processes and complete transfer and production of assays.- Original member, content creator and presenter at the Advanced Lateral Flow Course (2014-2017) on "Design Control and the Design and Implementation of an Assay Development Program".- Conducted market research and prepared market assessment and commercialization plan for novel diagnostic assay. Coordinated with Office of Innovation and Commercialization to bring potential technology from lab to market.
San Diego, Ca, Us
WHAT I DID: As an MBA Student Consultant, I was tasked to perform an Analysis of Best Practices in Global Support Processes and present it to the leaders of Illumina's Commercial Business Operations Team.ACCOMPLISHMENTS:- Benchmark Illumina’s mobile product offerings.- Identify and recommend best practices to improve customer interactions through a mobile app interface.- Benchmark Illumina’s online presence.- Identify opportunities and best practices for improvement in Illumina’s scientific online community and self-help forums.
WHAT I DID:As a Senior Scientist, I developed several in-vitro colloidal gold and fluorescent immunodiagnostic assays, ELISA, and molecular based assays ranging from bacterial, viral, and veterinary uses. ACCOMPLISHMENTS:- Developed a stable gold Heartworm conjugate for use as a component of a novel veterinary diagnostic product of a major company. - Involved in FDA pre-510(k) and 510(k) submission process, ISO audits, Design control procedure documents, food safety, and various meetings with domestic and foreign clients. - Computer networking/repair and part of social committee that plans and budgets various monthly company events.
San Antonio, Tx, Us
WHAT I DID:As a Lead Teaching Assistant, I assisted in teaching the 1st year medical microbiology course that is a part of the required medical student curriculum.ACCOMPLISHMENTS:- Assisted in education and management of other teaching assistants.- Development of curriculum for students and instructors.- Lead lectures, labs, and small group conferences in facilitating discussions.- Received Dr. Barbara A. Sanford Memorial Teaching Award in 2003.
Quick answers generated from the profile data available on this page.
Shrin Kuo works for Seegene USA.
Shrin Kuo is listed as Program/Project Management | Product Development | Strategy | Innovation at Seegene USA.
AeroLeads has found 1 work email signal at @fluxergy.com for Shrin Kuo at Seegene USA.
AeroLeads has found 2 phone signal(s) with area code 760 for Shrin Kuo at Seegene USA.
Shrin Kuo is based in Yorba Linda, California, United States while working with Seegene USA.
Shrin Kuo has worked for Seegene Usa, Fluxergy, Ipm Integrated Project Management Company, Inc., Dcn Diagnostics, and Illumina.
You can use AeroLeads to view verified contact signals for Shrin Kuo at Seegene USA, including work email, phone, and LinkedIn data when available.
Shrin Kuo holds Mba, Product Design And Development | Marketing | Strategy | Innovation from University Of California, San Diego - Rady School Of Management.
Shrin Kuo is listed with skills including Biochemistry, Life Sciences, Microbiology, Elisa, Protein Chemistry, Purification, Immunology, and Molecular Biology.
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