Ian Luksha
About Ian Luksha
Ian Luksha is a Manager of Quality Assurance CMC currently working remotely for both Bristol Myers Squibb and Karuna Therapeutics in Boston, Massachusetts. He has over 16 years of experience in the biopharmaceutical and medical device industries, specializing in quality oversight and management of GxP Quality Systems.
Current Roles
Ian Luksha currently holds the position of Manager Quality Assurance CMC at both Bristol Myers Squibb and Karuna Therapeutics. His role at these firms, both located in Boston, Massachusetts, is carried out remotely. At these organizations, Luksha oversees quality assurance processes to ensure that compliance, regulatory standards, and quality objectives are met within the manufacturing domains.
Past Experience in Quality Assurance
Ian Luksha has accumulated substantial experience in quality assurance through various roles. He served as a Senior QA Compliance Specialist at Akebia Therapeutics from 2021 to 2023. While at Sanofi, he worked as a Contract Manufacturing Quality Specialist from 2019 to 2021 and as a Senior Compliance Specialist from 2016 to 2019. His earlier career included positions at SeraCare Life Sciences, Merrimack Pharmaceuticals, and Genzyme. These roles have contributed to his expertise in quality systems management, compliance, and oversight.
Educational Background
Ian Luksha achieved his educational foundation at Westfield State University, where he pursued studies in General Science with a concentration in Chemistry, and Criminal Justice. He earned two Bachelor of Science degrees during his time at the university from 2004 to 2008.
Specializations and Skills in Quality Management
Specializing in quality oversight and management of both internal and external GxP Quality Systems, Ian Luksha brings extensive skills to his roles. His areas of expertise include Batch Record Review and Release, Deviation management, Corrective and Preventive Actions (CAPA), Change Control, and the review and approval of external documents related to drug substance and drug product manufacturing for both biologics and small molecules.
Experience in Biopharmaceutical Industry
With over 16 years of experience, Ian Luksha has gained in-depth knowledge and skills in the biopharmaceutical and medical device industries. Throughout his career, Luksha has held significant positions in renowned organizations such as Genzyme and Sanofi, contributing to quality control and assurance processes in various capacities. His practical experience is complemented by hands-on roles in both quality control and compliance, ensuring adherence to industry regulations and standards.