Spennandi tækifæri í þróunardeild mæliaðferða (ARD) / Exciting opportunities in the Analytical Research and Development department (ARD)

Við leitum að hæfum og áhugasömum einstaklingum til að ganga til liðs við þróunardeild mæliaðferða (ARD) hjá Alvotech í Reykjavík. Viðkomandi munu ganga til liðs við teymi þar sem áhersla er á sýnameðhöndlun og sértækar greiningarðferðir, svo sem litskiljun (e. Chromatography). Eftir ítarlega þjálfun munu viðkomandi aðilar taka þátt í greiningum á sýnum með það að markmiði að styðja við vöruþróun Alvotech og umsóknir til lyfjayfirvalda. Þeir munu einnig þróa og gilda nýjar aðferðir til að greina og stuðla að gæðastjórnun á líftæknilyfjum frá Alvotech.Um deildinaÞróunardeild mæliaðferða tilheyrir sviði rannsókna og þróunar hjá Alvotech. Helstu verkefni deildarinnar eru að þróa og gilda mæliaðferðir, greina sýni í þágu rannsókna og þróunar, og styðja aðrar deildir með rannsókna- og þróunarvinnu, meðal annars í tengslum við samskipti við lyfjayfirvöld.Helstu verkefni og ábyrgð:ChromatographyÞróa, betrumbæta og gilda greiningaraðferðir fyrir litskiljun.Skrifa þróunarskýrslur, gildingarlýsingar og skýrslur, verklýsingar og gæðaskjöl ætluð yfirvöldum.Framkvæma sýnagreiningar til að styðja við vöruþróun í gegnum allan líftíma vörunnar.Framkvæma reglubundin þrif, sannprófun og viðhald á búnaði á rannsóknarstofu.Greina mikilvæg hvarfefni, svo sem viðmiðunarefni.Framkvæma nauðsynlegar breytingar á skjölum, uppfæra gæðaskjöl eftir þörfum.Sample ManagementTaka á móti og deila niður sýnum til mælinga.Halda skrá yfir staðsetningar á efnum og sýnum.Almenn sýnameðhöndlun.Skrifa og fara yfir skjöl fyrir sýnamælingar.Taka á móti sendingum og undirbúa efni og sýni til sendingar.Undirbúa sýni fyrir stöðugleika.Menntunar og hæfniskröfur:Bakkalár gráða á viðeigandi sviði er æskileg. Sambærileg starfsreynsla er kostur en ekki skylda.Framúrskarandi samskiptahæfni; frumkvæði og nákvæmni í vinnubrögðum.Mjög góð enskukunnátta, bæði í rituðu og töluðu máli.Reynsla af GMP er kostur en ekki nauðsynleg.Kunnátta í Microsoft Office.[English]We are seeking skilled and motivated personnel to join the Analytical Research and Development team at Alvotech in Reykjavik. Selected candidates will join teams focused on sample management and chromatographic analysis. After comprehensive training, Analytical Development scientists will be involved in sample analysis to support product development and regulatory submissions. They will also develop and optimize new analytical methods for the characterization and quality control of Alvotech biopharmaceutical products.About The DepartmentThe Analytical Research and Development (ARD) department is part of the R&D organization within Alvotech. The primary role of ARD is to develop, optimize, and validate analytical methods, as well as support regular sample analysis to drive product development programs. Additionally, ARD is responsible for executing analytical strategies and assisting in the preparation of regulatory documentation.Scope & Responsibilities:ChromatographyDevelop, optimize, and validate analytical methods for chromatographic analysis.Perform method development/optimization and write development reports and SOPs.Conduct sample analysis to support product development throughout the product lifecycle.Perform routine cleaning, verification, and maintenance of laboratory equipment.Qualify and optimize critical reagents, such as reference materials.Identify and implement required document changes, updating quality documentation as necessary.Sample ManagementReceive and aliquot material for analytical testing.Inventory management of both samples and materials.General sample handling and buffer preparation.Prepare and review documents required for sample testing and shipping.Receive and prepare samples and material for shipments.Prepare samples for stability studies.Qualifications and skills:Bachelor’s degree in a relevant field is preferred. Relevant professional experience is advantageous but not mandatory.Excellent communication skills; proactive, detail-oriented, and precise work habits.Fluent in English, both written and verbal.GMP experience is desired but not required.Proficiency in Microsoft Office.What we offer:An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.The chance to be a part of a global and fast-growing company.An international work culture that encourages diversity, collaboration and inclusion.Positive, flexible, and innovative work environment.Support for personal growth and internal career development.Company social events and milestone celebrations.Excellent in-house canteen and coffee house.Exercise and wellbeing support for full-time employees.On-site shower facility.Transportation grant towards eco-friendly modes of travel for full-time employees.Internet at home for full-time employees.Why AlvotechAt 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.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.