Description

<div><div>About the Department/Company </div><div>Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on development and manufacturing of high-quality biosimilar medicines. </div><div>Within Research and Development (R&D) function, the integrated Clinical and Medical Research (iCMR) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. </div><div>iCMR is launching an ambitious and exciting project aimed at modernizing and optimizing the departmental operating model. As part of this project, we are recruiting for the following position: </div><div> </div><div>Overview of Job Role </div><div>Alvotech is looking to hire a Manager to setup and lead the laboratory equipment qualification and software validation group at the BioAnalytics Laboratory in Stockholm (Sweden). This role offers the opportunity to set up a new bioanalytical lab dedicated to the analysis of PK and immunogenicity samples originating from Alvotech’s sponsored clinical trials. </div><div>We seek an experienced laboratory manager with a deep understanding of equipment qualification and software validation. Your expertise will be crucial in running the bioanalytical laboratory in compliance with global standards. </div><div>Scope and responsibility: </div><div><ul><li>Setup and management of processes for equipment qualification, equipment maintenance and software validation </li></ul></div><div><ul><li>Implementation and coordination of sample management processes using LIMS (inhouse samples and samples received from clinical studies) </li></ul></div><div><ul><li>Management of a laboratory temperature monitoring system </li></ul></div><div><ul><li>Responsible person for the data and material archive </li></ul></div><div><ul><li>Support of sample logistics processes (shipment of samples from trial sites) </li></ul></div><div><ul><li>Support of QA processes (deviations, CAPA, SOP generation/update, inspections/audits etc.) </li></ul></div><div><ul><li>Ensuring GCLP compliance and high-quality standards for Alvotech's sponsored clinical trials </li></ul></div><div>Job requirements: </div><div><ul><li>Training as a Master/Engineer in a related discipline (e.g. biology, biotechnology, biochemistry) </li></ul></div><div><ul><li>Minimum of 5 years of experience in position related tasks </li></ul></div></div><div><div><ul><li>Experience with equipment qualification and maintenance typical for bioanalytical labs, e.g. for spectrophotometer, ELISA reader (Electrochemiluminescence reader), plate washer, shaker, pH meter, balance, centrifuge, (deep) freezer, pipettes, temperature monitoring system </li></ul></div><div><ul><li>Experience with software validation of relevant equipment software and LIMS to meet 21CFR part 11 requirements </li></ul></div><div><ul><li>Experience of work in a regulated environment (e.g. GCP, GLP) </li></ul></div><div><ul><li>Good Technical knowledge and strong organization skills </li></ul></div><div><ul><li>Experience with large molecules and biosimilars is of advantage </li></ul></div><div><ul><li>Fluency in English, both written and spoken. </li></ul>What we offer:<ul><li>Meaningful Work: Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.</li><li>Global Growth: Join a fast-growing, international company with a diverse and inclusive culture.</li><li>Collaborative Environment: Work in a positive, flexible, and innovative setting that values teamwork and creativity.</li><li>Career Development: Benefit from support for personal growth, internal mobility, and ongoing training opportunities.</li><li>Cultural Exchange: Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.</li><li>Well-being & Perks: Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.</li><li>Community & Celebration: Participate in regular social events and celebrate team milestones together.</li></ul></div></div>

Laboratory Manager - Bioanalytics

Description

Alvotech

Pipeline