Kevin Kou
Arcadia,California
Summary
Skilled and adaptable Lab Operations Manager with a demonstrated history working in multiple highly regulated industries including Cell and Gene Therapies, healthcare, E-commerce, and consumer electronics. Knowledgeable in EH&S processes, Operations Management, Procurement Analytics, and Cross-functional Collaboration.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Laboratory Operations Manager, R&D
Theragent Inc
01.2023 - Current
- Established internal process changes and cross-functional collaboration for inventory management, ordering and receiving of consumables, and operational workflows to support technical staff in R&D, Viral Vector, Analytical Development and Process Sciences.
- Contributed to and implemented EH&S programs to oversee aspects of Non-GMP facility safety, including developing and maintaining SOPs and biosafety procedures for Covina lab facility, while also aligning with our Arcadia GMP manufacturing site.
- Conducted regulatory walkthroughs and audits of company facilities to ensure adherence to established regulations, while identifying areas for improvement within EHS processes.
- Managed HAZMAT Waste program for Theragent Covina R&D site (biohazard, sharps, HAZMAT waste) and ensured adherence to local, state, and countrty regulatory requirements (EHS, GLP and GDP).
Lab Operations Manager - Sr. Operations Manager
JUUL Labs
08.2018 - 06.2023
- Coordinated with Accounts Payable and Global Supply Purchasing to procure over $15M in laboratory equipment and supplies with Acumatica and Stampli throughout employment.
- Oversee laboratory equipment performance by establishing quality standards; ensuring staff compliance; certifying performance; arranging equipment replacement, service, and repair.
- Spearheaded process changes and improvements to raw material procurement methods to maximize purchase efficiency and pricing, resulting in over $500K of budget saved from 2021-2022.
- Administered EHS audits/routine walkthroughs and compliance checks to comply with Waste Management/Regulatory guidelines, resulting in perfect city inspection results with minor recommendations for EHS process improvement.
- Assisted EHS with Waste Management and Implementation/evaluation of quality systems, using Regulatory/Quality guidelines such as FDA, GLP, GDP, QSR, GMP, USP, CDR, and ISO.
Administrative Specialist
Kaiser Permanente
05.2017 - 08.2018
- Gatekeeper for all procurement and tracking of all medical/office materials, supplies, and CAPEX for 4 pediatric clinic locations utilizing SAP Ariba and approved requisitions for purchase orders.
- Prepared monthly high-level data reports to senior management by extracting data from EPIC to Excel, utilizing pivot tables and VLOOKUP functions.
- Onboarded new staff on administrative procedures, promoting a culture of knowledge sharing and continuous improvement.
Education
B.S. - Business Administration and Information Systems
University of California, Riverside
01.2017
Master of Science - Healthcare Administration
Purdue University
West Lafayette, IN05-2026
Skills
- Facilities Procurement
- Environmental Health & Safety
- Employee Relations and Conflict Resolution
- Contractor/Vendor Management
- Project Management
- Process Improvement
- CAPEX/OPEX
- OSHA Compliance
- LIMS
- Microsoft Office Suite
Certification
- DOT Hazardous Materials Transportation (2018 - Present)
- IATA Dangerous Goods Transportation (2018 - Present)
- RCRA Resource Conservation and Recovery Act (2021-10 - Present)
- DTSC Department of Toxic Substances Control (2021-10 - Present)
LANGUAGES
English - Full Professional Proficiency
Chinese - Full Professional Proficiency
ADDITIONAL EXPERIENCE
English Language Development Educator - STEPS Academy (2014 - 2022)
Procurement Specialist, Facilities & Operations - Newegg (2020-2021)
Timeline
Laboratory Operations Manager, R&D
Theragent Inc
01.2023 - Current
Lab Operations Manager - Sr. Operations Manager
JUUL Labs
08.2018 - 06.2023
Administrative Specialist
Kaiser Permanente
05.2017 - 08.2018
B.S. - Business Administration and Information Systems
University of California, Riverside
Master of Science - Healthcare Administration
Purdue University
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