Senior Specialist, Quality Control

Senior Specialist in the Quality Control department at Alvotech's Reykjavík headquarters, providing scientific oversight of analytical methods for product testing. The specialist leads analytical method technology transfers between Alvotech and contract manufacturing organisations and the lifecycle management of analytical methods, acts as subject-matter expert for chromatography, electrophoresis, compendial and biochemical test methods, authors and reviews transfer protocols, reports and validation documents, leads investigations of analytical quality events such as invalid assays and out-of-specification, out-of-trend and out-of-expectation results, prepares scientific justifications for health-authority inquiries, manages CAPAs, change controls and deviations under cGMP, works with analytical development, regulatory, manufacturing and quality assurance teams, and trains other scientists in analytical methods.

A bachelor's or master's degree in a technical discipline such as pharmacy, biotechnology or biochemistry; 5–10 years of experience in the pharmaceutical or biopharmaceutical industry; proven experience in analytical method technology transfer and product lifecycle management; strong experience managing CAPAs, change controls, deviations and complex analytical investigations; experience supporting regulatory submissions and responding to health-authority queries; expert knowledge of relevant methods and techniques; openness to flexible working hours; excellent written and verbal communication.