Scientific Director - BioAnalytics
Full-timeExecutive
Description
<div><div><p><b><span>About the Department/Company</span></b><span> </span></p></div><div><p><span><span>Alvotech is a fully integrated specialty biopharmaceutical company focused exclusively on<span> </span></span><span>development</span><span><span> </span>and manufacturing of high-quality biosimilar medicines. </span></span><span> </span></p></div><div><p><span><span>Within Research and Development (R&D) function, the integrated Clinical and Medical Research (</span><span>iCMR</span><span>) department develops effective strategies aligned with biosimilar guidelines and health authority requirements to deliver successful clinical studies, and support post marketing-authorization related activities. </span></span><span> </span></p></div><div><p><span><span>iCMR</span><span><span> </span>is launching an ambitious and exciting project aimed at modernizing and<span> </span></span><span>optimizing</span><span><span> </span>the departmental operating model. As part of this project, we are recruiting for the following position:</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><b><span>Overview of Job Role</span></b><span> </span></p></div><div><p><span><span>Alvotech is looking to hire</span><span> a<span> </span></span></span><b><span>Scientific Director<span> </span></span></b><span><span>to lead<span> </span></span><span>the operational unit of<span> </span></span></span><b><span>Alvotech’s</span><span><span> </span>bioanalytical laboratory<span> </span></span><span>in Stockholm (Sweden)</span></b><span><span><span> </span></span><span>and drive high quality analytical support for<span> </span></span><span>our</span><span><span> </span>clinical programs. </span></span><span> </span></p></div><div><p><span><span>The Scientific Director provides strategic, scientific, and operational leadership for the bioanalytical laboratory. This role oversees the development, validation, and execution of bioanalytical methods to support<span> </span></span><span>our<span> </span></span><span>clinical programs. The Scientific Director ensures scientific excellence, regulatory compliance, and efficient delivery of<span> </span></span><span>high quality</span><span><span> </span>data across the portfolio.</span><span><span> </span></span><span>The ideal candidate combines deep scientific<span> </span></span><span>expertise</span><span><span> </span>with strong leadership and regulatory understanding.</span></span><span> </span></p></div><div><p><span> </span></p></div><div><p><b><span>Scope and responsibility</span><span>:</span></b><span> </span></p></div><div><ul><li><p><span><span>Provide scientific direction for bioanalytical strategy</span><span><span> </span></span><span>aligning with clinical development goals</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Oversee development, validation, and implementation of bioanalytical assays (PK, ADA, NAB, Biomarker, cell-based assays) and review critical documentation (SOPs, validation plans, study protocols, final reports)</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Oversee execution of regulated bioanalytical studies (GLP/GCP) and ensure data integrity</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Lead and mentor a team of scientists</span><span><span> </span>and technicians</span><span>; foster a collaborative, high performance culture</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Serve as subject matter expert for ligand binding assays, and biomarker analytics</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Represent the lab externally in scientific conferences, publications, and collaborations</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Represent the bioanalytical function in audits, regulatory interactions, and cross functional teams</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Drive innovation through<span> </span></span><span>new technologies</span><span><span> </span>and continuous improvement initiatives</span></span><span> </span></p></li></ul><p></p></div><div><p><b><span>Job requirements</span><span>:</span></b><span> </span></p></div></div><div><div><ul><li><p><span><span>PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field (or equivalent experience)</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>10+ years of bioanalytical experience in pharma, biotech, or CRO environments</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Proven leadership and strong understanding of regulatory guidance<span> </span></span><span>(FDA, EMA, ICH, OECD) for bioanalysis.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Demonstrated<span> </span></span><span>track record</span><span><span> </span>of scientific innovation and problem solving.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Expertise</span><span><span> </span>with ligand binding assay platforms,<span> </span></span><span>e.g.</span><span><span> </span>MSD ECL Technology</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Exposure to biosimilars or large molecules</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Excellent communication and<span> </span></span><span>problem-solving</span><span><span> </span>skills</span></span><span> </span></p></li></ul></div></div><p></p><p><span><b>What we offer:</b></span></p><ul><li><p><span><b>Meaningful Work:</b> Tackle inspiring challenges with passionate colleagues on projects that make a real difference in people’s lives.</span></p></li><li><p><span><b>Global Growth:</b> Join a fast-growing, international company with a diverse and inclusive culture.</span></p></li><li><p><span><b>Collaborative Environment: </b>Work in a positive, flexible, and innovative setting that values teamwork and creativity.</span></p></li><li><p><span><b>Career Development:</b> Benefit from support for personal growth, internal mobility, and ongoing training opportunities.</span></p></li><li><p><span><b>Cultural Exchange: </b>Take advantage of exchange opportunities with our Reykjavik, Iceland lab for short or long-term stays.</span></p></li><li><p><span><b>Well-being & Perks:</b> Enjoy wellness benefits, on-site changing rooms, and a stocked office with snacks, fruit, and great coffee.</span></p></li><li><p><span><b>Community & Celebration:</b> Participate in regular social events and celebrate team milestones together.</span></p></li></ul><p></p>
Alvotech
BIOTECHNOLOGY
Biosimilars
LocationLUXEMBOURG, Luxembourg
Open Jobs43
ImmunologyNeurologyGastroenterologyOphthalmology
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