Celine Lin
About Celine Lin
Celine Lin is a Senior Manager of Quality Assurance (Analytical) at Ardelyx, Inc., with over 20 years of experience in the pharmaceutical industry. She has a strong background in managing teams and regulatory submissions, and she holds a degree from Xiamen University.
Work at Ardelyx
Celine Lin has been serving as the Senior Manager of Quality Assurance (QA) for Analytical at Ardelyx, Inc. since 2018. Based in Fremont, California, she has accumulated six years of experience in this role. Her responsibilities include overseeing quality assurance processes related to analytical testing, ensuring compliance with regulatory standards, and managing teams involved in product quality assessments.
Education and Expertise
Celine Lin studied at Xiamen University, where she developed a strong foundation in pharmaceutical sciences. She possesses extensive expertise in Immediate and Extended Release solid dosage forms. Her academic background and professional experience contribute to her proficiency in cGMP, FDA Regulations, and ICH Guidelines.
Background in Pharmaceutical Industry
Celine Lin has a significant background in the pharmaceutical industry, having worked at Impax Laboratories for nine years in various roles. She began as a Team Leader/Chemist II in the Stability Group from 2002 to 2004, then progressed to Manager of R&D Analytical from 2014 to 2017, and served as Senior Supervisor of R&D Analytical from 2004 to 2013. Prior to her time at Impax, she worked as a Graduate Research Assistant at the National University of Singapore from 1993 to 1995.
Regulatory Submissions and Quality Management
Celine Lin has authored or reviewed over 80 regulatory submission filings throughout her career. She has managed laboratory investigations and Corrective and Preventive Actions (CAPA), demonstrating her capability in quality management. Additionally, she has reviewed and approved Standard Operating Procedures (SOPs) and test methods, ensuring adherence to industry standards.