Job Description
Job Title: Analytical Method Lifecycle Specialist – Bioassay (Senior Associate Level)Job Description
The Analytical Method Lifecycle Specialist plays a critical role on the Bioassay team, providing site-wide analytical and quality support for biologics and gene therapy platforms. This position focuses on method transfers, qualifications, validations, and stability testing, ensuring robust and compliant nucleic acid and cell-based assays in a fast-growing, startup CDMO environment.
Responsibilities
+ Plan, lead, and execute analytical method lifecycle activities, including method transfers, qualifications, validations, and stability testing for biologics and gene therapy assays.
+ Work on method lifecycle projects involving HPLC, ensuring methods are appropriately developed, transferred, and validated for routine use.
+ Draft, review, and maintain technical documents such as protocols, standard operating procedures (SOPs), and technical reports to suppor...
The Analytical Method Lifecycle Specialist plays a critical role on the Bioassay team, providing site-wide analytical and quality support for biologics and gene therapy platforms. This position focuses on method transfers, qualifications, validations, and stability testing, ensuring robust and compliant nucleic acid and cell-based assays in a fast-growing, startup CDMO environment.
Responsibilities
+ Plan, lead, and execute analytical method lifecycle activities, including method transfers, qualifications, validations, and stability testing for biologics and gene therapy assays.
+ Work on method lifecycle projects involving HPLC, ensuring methods are appropriately developed, transferred, and validated for routine use.
+ Draft, review, and maintain technical documents such as protocols, standard operating procedures (SOPs), and technical reports to suppor...