Expert Scientist – New Product Introduction

<p>Við leitum að reynslumiklum og lausnamiðuðum sérfræðingi í Drug Product (DP) framleiðsluferlum. Í þessu hlutverki berðu ábyrgð á tæknilegri starfsemi, stuðningi við daglega framleiðslu og innleiðingu nýrra vara og ferla í GMP framleiðslu. Starfið hentar einstaklega vel fyrir einstakling með djúpan skilning á líftækniframleiðslu og DP‑ferlum sem vill taka virkan þátt í tækniþróun, ferlastjórnun og lykilákvörðunum í öflugu framleiðsluumhverfi.</p><p></p><p><b>(English)</b></p><p></p><p>We are seeking a skilled and motivated Drug Product (DP) Subject Matter Expert (SME) to support drug product manufacturing operations and lead key technical activities. In this role, you will provide expert guidance, support technology transfer, drive process improvements, and ensure DP processes are well‑defined, controlled, and compliant with cGMP standards. This position is ideal for a collaborative and detail‑oriented professional with strong technical understanding of bioprocessing, formulation, compounding, and aseptic operations.</p><p></p><div><p><b>Scope and Responsibilities</b></p><div><div><div><ul><li><p>Act as the Drug Product (DP) Subject Matter Expert and provide technical guidance to support routine manufacturing activities.</p></li><li><p>Lead the introduction of new products and DP processes into GMP manufacturing, ensuring smooth transfer and clear communication of critical process information.</p></li><li><p>Author and review essential DP documentation, such as process descriptions, protocols, reports, deviations, change controls, and CAPAs.</p></li><li><p>Monitor DP process performance and analyze data to identify trends, deviations, and opportunities for improvement.</p></li><li><p>Support troubleshooting and perform root cause investigations to resolve complex formulation, filtration, or aseptic‑processing issues.</p></li><li><p>Contribute to technology transfer activities from development to GMP scale, including risk assessment and documentation preparation.</p></li><li><p>Assess and support the qualification of new raw materials, excipients, consumables, components, and alternate suppliers.</p></li><li><p>Collaborate with cross‑functional teams to ensure aligned timelines, quality standards, and technical deliverables.</p></li><li><p>Participate in process scale‑up and support activities related to DP equipment, automation, and process control.</p></li></ul><p></p></div></div><p><b>Job Requirements </b></p><ul><li><p>Master’s or Bachelor’s degree in Life Sciences or a related field.</p></li><li><p>5–10 years of experience in the biopharmaceutical industry.</p></li><li><p>Working knowledge of GMP manufacturing.</p></li><li><p>Experience with upstream bioprocessing and technology transfer.</p></li><li><p>Strong problem‑solving, communication, and data analysis skills.</p></li></ul><p></p><p><b>What we offer:</b></p><ul><li><p>An inspiring challenge to work with great co-workers on ambitious projects that change people&#39;s lives.</p></li><li><p>The chance to be a part of a global and fast-growing company.</p></li><li><p>An international work culture that encourages diversity, collaboration and inclusion.</p></li><li><p>Positive, flexible, and innovative work environment.</p></li><li><p>Support for personal growth and internal career development.</p></li></ul></div></div><div><div><ul><li><p>Company social events and milestone celebrations.</p></li><li><p>Excellent in-house canteen and coffee house.</p></li><li><p>Exercise and wellbeing support for full-time employees.</p></li><li><p>On-site shower facility.</p></li><li><p>Transportation grant towards eco-friendly modes of travel for full-time employees.</p></li><li><p>Internet at home for full-time employees</p></li></ul><p></p><p><b>Why Alvotech</b></p><p>At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.</p><p></p><p>True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.</p></div></div>