Quality Control Technician

Company Description: Throne Biotechnologies is a clinical development company dedicated to leveraging of stem cell innovations for the practical cure of diabetes and autoimmune diseases. Their primary focus is to comprehensively reverse the root causes of autoimmune diseases with a new and world-leading stem cell technology. As a fast growing startup, Throne is currently undergoing the clinical trial phase to acquire FDA commercial approval to take this technology globally.

Job Description:
As part of a small and nimble startup team of world class scientists, doctors, business execs, and innovators, the candidate will be on the frontlines of launching one of the most disruptive medical technologies in the current era. You are expected to wear multiple hats, be a proactive self starter, be a fast learner, and have a high attention to detail.

We are seeking a GMP QA/QC Professional to oversee quality systems pertaining to manufacturing and regulatory compliance activities for clinical material. This will include management of batch manufacturing and testing activities to ensure cGMP compliance.

Responsibilities:
Act as subject matter expert (SME) for GMP QA/QC topics
Execution of company lot disposition packages for finished clinical trial material
Assist in quality system development — Write, revise, and periodically review SOPs
Management of document control, deviations and Corrective and Preventive Action (CAPA)
Participate in CMC (Chemistry, Manufacturing and Control) team meetings, providing QA/QC support
Review of master batch records, specifications, test methods, stability protocols, and reports
Review and approve executed batch records, analytical data, change controls, deviations, out of specification (OOS), etc.
Review of contract manufacturing organization (CMO) lot disposition packages

Requirements:
BS/BA in Biology or a related life science discipline; and/or 3 years of experience within GMP quality functions of pharmaceutical/biotech industry
Experience working in a Biological Safety Cabinet using aseptic technique
Experience working in cell cultures
Experience processing in human blood mononuclear cells
Experience working in flow cytometry
Experience working in real time PCR
Ability to read, execute and document steps in a GMP batch record
Ability to work independently
Proactive execution of day-to-day activities
Experience in auditing CMO and contract testing laboratory (CTL) is a bonus
Ability to pass pre-employment drug and background screen