{"data":{"id":210254,"slug":"utredare-bioteknologi-med-fokus-pa-lakemedel-for-avancerade-terapier-atmp","type":"job","title":"Investigator Biotechnology with Focus on Advanced Therapy Medicinal Products (ATMP)","description":"At L\u00e4kemedelsverket, we make a difference together. In life and for life. We work for the health of people and animals, for a better Sweden today and in the future.\nDo you have experience in development and\/or manufacturing of advanced therapy medicinal products (ATMPs)? Does it sound exciting to you to evaluate documentation concerning manufacturing, characterization, and control of ATMPs? The Unit for Pharmaceuticals and Biotechnology (FoB) is looking for a new colleague!\nOur Operations\nThe Approvals operations area works in several ways to ensure that appropriate medicines reach patients. Approvals of new medicines, safety monitoring, and management of changes to approved products are central parts of our mission, as is advice on medicine development and information about medicines. The Unit for Pharmaceuticals and Biotechnology consists of over 90 employees working within a broad scientific area. The unit is responsible for evaluating documentation concerning manufacturing, characterization, and control of medicines in applications for approval. This evaluation, together with that of medicines' efficacy and safety (investigated by other units), forms the basis for decisions on whether a medicine can be approved for clinical use. Investigation work also occurs in collaboration with other EU member states.\nOur unit is growing and we are looking for an investigator for the Biotechnology Group, which investigates applications for biological medicines. The focus area for this position is the assessment of ATMPs.\nYour Tasks\nYour main task as an investigator is to conduct a critical scientific assessment of the quality of ATMPs based on documentation of how the products have been developed, characterized, manufactured, and controlled. The evaluation includes both the active substance and the finished product. The work is varied and covers a product's entire lifecycle; scientific advice, clinical trials, approval of new medicines, and change applications. Assessments are documented in investigation reports. The work offers good opportunities for professional development through a varied work environment where independent work alternates with close collaboration, both internally and with other agencies. Tasks include approval of medicines as well as development of requirements and guidelines within the area of responsibility. Additionally, European collaboration may enable engagement in various expert groups.\nYour Background\nWe are looking for someone with a natural sciences university or college degree. You also have several years of professional experience in areas relevant to this position. You have solid knowledge of the development and\/or manufacturing of ATMPs. Daily work requires good ability to communicate in speech and writing in English. Good ability to understand Swedish speech and writing is also required.\nIt is meriting if you also have experience with:\nResearch education in a relevant area\nExperience in process development and characterization of ATMPs\nPrevious work with pharmaceutical regulatory documentation\nPrevious work with development\/validation of analytical test methods\nExperience with bioinformatic analyses\n\nYour Personal Qualities\nYou have scientific thinking, are curious and engaged, and are stimulated by working in an environment with broad scientific and regulatory expertise. You are analytical and can absorb extensive and complex information, make rational assessments, and compile these in a clear manner within established timeframes. You are thorough and work methodically and systematically, while maintaining the quality and productivity the role requires. You work independently, act trustworthy, and are responsible. You have good ability to collaborate and create dialogue and team spirit. You share your knowledge and care about your own and your team's development.\nWe place great importance on personal qualities.\nGood to Know\nApplication Deadline: 2026-10-05\nEmployment Form: Permanent\nStart Date: By agreement\nUnit: Pharmaceuticals and Biotechnology\nFile Number: 2.4.1-2026-074312\nWe apply a 6-month probationary period. We value diversity and welcome applicants from different backgrounds.\nAt L\u00e4kemedelsverket, you get good conditions for work-life balance. We offer you, among other things, flexible hours, favorable vacation terms, wellness allowance, and wellness activities during work time. There is also the opportunity to work partially remotely.\nRead more about the benefits you receive from us here: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\/formaner-hos-oss\nL\u00e4kemedelsverket is a crisis management agency, which means we conduct certain background checks in connection with recruitments. You will need to prove your identity and present diplomas and relevant certificates at any interview. All permanent employees at L\u00e4kemedelsverket are allocated for civil contingency within the agency.\nContact\nYou are welcome to contact group manager Anna-Karin Maltais. You can also contact the union representatives Jonas Walld\u00e9n, Saco and Pia Wictor, ST. We are all available at telephone 018-17 46 00 or can be reached by email firstname.lastname@lakemedelsverket.se.\nMore About L\u00e4kemedelsverket\nYou may not think about L\u00e4kemedelsverket very often, but we can promise that you encounter us in your everyday life. The result of what we do is noticeable in pharmacies, hospitals, at the veterinarian, and in your bathroom cabinet. We ensure that you and everyone else in Sweden have access to safe and effective medicines and medical devices, everything from plasters and pregnancy tests to walkers and apps. We do this by approving and issuing permits, monitoring and controlling, and by informing and providing advice. We who work at L\u00e4kemedelsverket are proud of our important societal mission: to contribute to Swedish public and animal health.\nRead more about our mission and what it means to work at L\u00e4kemedelsverket here: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\nWe look forward to your application!\nThis recruitment is conducted entirely by L\u00e4kemedelsverket. We therefore decline phone calls from recruitment firms and advertising sales representatives.","language":"sv","is_translated":true,"title_original":"Utredare bioteknologi med fokus p\u00e5 l\u00e4kemedel f\u00f6r avancerade terapier (ATMP)","description_original":"P\u00e5 L\u00e4kemedelsverket g\u00f6r vi skillnad tillsammans. I livet och f\u00f6r livet. Vi jobbar f\u00f6r m\u00e4nniskors och djurs h\u00e4lsa, f\u00f6r ett b\u00e4ttre Sverige idag och i framtiden.\nHar du erfarenhet av utveckling och\/eller tillverkning av l\u00e4kemedel f\u00f6r avancerade terapier (Advanced Therapy Medicinal Products, ATMPs)? Tycker du det l\u00e5ter sp\u00e4nnande att v\u00e4rdera dokumentationen r\u00f6rande tillverkning, karakterisering och kontroll av ATMPs? Vi p\u00e5 Enheten f\u00f6r Farmaci och Bioteknologi (FoB) s\u00f6ker en ny kollega!\nV\u00e5r verksamhet\nVerksamhetsomr\u00e5det Tillst\u00e5nd verkar p\u00e5 flera s\u00e4tt f\u00f6r att \u00e4ndam\u00e5lsenliga l\u00e4kemedel ska n\u00e5 patienten. Godk\u00e4nnanden av nya l\u00e4kemedel, s\u00e4kerhetsuppf\u00f6ljning och hantering av \u00e4ndringar av godk\u00e4nda produkter \u00e4r centrala delar i v\u00e5rt uppdrag, liksom r\u00e5dgivning avseende l\u00e4kemedelsutveckling och information om l\u00e4kemedel. Enheten f\u00f6r Farmaci och Bioteknologi best\u00e5r av drygt 90 medarbetare som arbetar inom ett brett vetenskapligt omr\u00e5de. Enheten ansvarar f\u00f6r v\u00e4rdering av dokumentationen r\u00f6rande tillverkning, karakterisering och kontroll av l\u00e4kemedel i ans\u00f6kningar om godk\u00e4nnande. V\u00e4rderingen, tillsammans med den f\u00f6r l\u00e4kemedlens effekt och s\u00e4kerhet (som utreds av andra enheter), ligger till grund f\u00f6r beslut om ett l\u00e4kemedel kan godk\u00e4nnas f\u00f6r kliniskt bruk. Utredningsarbetet sker \u00e4ven i samverkan med andra medlemsl\u00e4nder i EU.\nV\u00e5r enhet v\u00e4xer och vi s\u00f6ker en utredare till Bioteknologigruppen som utreder ans\u00f6kningar om biologiska l\u00e4kemedel. Fokusomr\u00e5det f\u00f6r denna tj\u00e4nst \u00e4r bed\u00f6mning av ATMPs.\nDina arbetsuppgifter\nDin huvuduppgift som utredare \u00e4r att g\u00f6ra en kritisk vetenskaplig bed\u00f6mning av kvaliteten hos ATMPs baserad p\u00e5 dokumentationen f\u00f6r hur produkterna utvecklats, karakteriserats, tillverkas och kontrolleras. V\u00e4rderingen innefattar s\u00e5v\u00e4l l\u00e4kemedelssubstans som l\u00e4kemedelsprodukt. Arbetet \u00e4r varierande och omfattar en produkts hela livscykel; vetenskapliga r\u00e5dgivningar, kliniska pr\u00f6vningar, godk\u00e4nnande av nya l\u00e4kemedel och \u00e4ndringsans\u00f6kningar. Bed\u00f6mningarna dokumenteras i utredningsrapporter. Arbetet erbjuder goda m\u00f6jligheter till professionell utveckling genom en varierad arbetsmilj\u00f6 d\u00e4r sj\u00e4lvst\u00e4ndigt arbete varvas med ett n\u00e4ra samarbete, b\u00e5de internt och med andra myndigheter. Uppgifterna omfattar godk\u00e4nnande av l\u00e4kemedel samt utveckling av krav och riktlinjer inom ansvarsomr\u00e5det. Dessutom kan det europeiska samarbetet m\u00f6jligg\u00f6ra engagemang i olika expertgrupper.\nDin bakgrund\nVi s\u00f6ker dig som har en naturvetenskaplig universitets- eller h\u00f6gskoleutbildning. Du har \u00e4ven fler\u00e5rig yrkeserfarenhet inom f\u00f6r tj\u00e4nsten relevant omr\u00e5de. Du har gedigen kunskap om utveckling och\/eller tillverkning av ATMPs. Det dagliga arbetet st\u00e4ller krav p\u00e5 god f\u00f6rm\u00e5ga att kommunicera i tal och skrift p\u00e5 engelska. Det kr\u00e4vs \u00e4ven god f\u00f6rm\u00e5ga att f\u00f6rst\u00e5 svenskt tal och skrift.\nDet \u00e4r meriterande om du \u00e4ven har erfarenhet av:\nForskarutbildning inom relevant omr\u00e5de\nErfarenhet fr\u00e5n processutveckling och karakterisering av ATMPs\nTidigare arbete med farmaceutisk regulatorisk dokumentation\nTidigare arbete med utveckling\/validering av analytiska testmetoder\nErfarenhet av bioinformatiska analyser\n\nDina personliga egenskaper\nDu har ett vetenskapligt t\u00e4nkande, \u00e4r nyfiken och engagerad och stimuleras av att f\u00e5 arbeta i en milj\u00f6 med bred vetenskaplig och regulatorisk kompetens. Du \u00e4r analytisk och kan tillgodog\u00f6ra dig omfattande och komplex information, g\u00f6ra rationella bed\u00f6mningar och sammanst\u00e4lla dessa p\u00e5 ett tydligt s\u00e4tt inom fastst\u00e4llda tidsramar. Du \u00e4r noggrann och arbetar metodiskt och systematiskt, samtidigt som du uppr\u00e4tth\u00e5ller den kvalitet och produktivitet som rollen kr\u00e4ver. Du arbetar sj\u00e4lvst\u00e4ndigt, agerar f\u00f6rtroendeingivande och \u00e4r ansvarstagande. Du har god f\u00f6rm\u00e5ga att samarbeta och att skapa dialog och laganda. Du delar med dig av dina kunskaper och v\u00e4rnar om din och gruppens utveckling.\nVi l\u00e4gger stor vikt vid personliga egenskaper.\nBra att veta\nSista ans\u00f6kningsdag: 2026-10-05\nAnst\u00e4llningsform: Tillsvidare\nTilltr\u00e4de: Enligt \u00f6verenskommelse\nEnhet: Farmaci och bioteknologi\nDiarienummer: 2.4.1-2026-074312\nVi till\u00e4mpar 6 m\u00e5naders provanst\u00e4llning. Vi v\u00e4rdes\u00e4tter m\u00e5ngfald och v\u00e4lkomnar s\u00f6kande med olika bakgrund.\nP\u00e5 L\u00e4kemedelsverket f\u00e5r du goda f\u00f6ruts\u00e4ttningar f\u00f6r balans i livet. Vi erbjuder dig bland annat flextid, f\u00f6rm\u00e5nliga semestervillkor, friskv\u00e5rdsbidrag samt friskv\u00e5rd p\u00e5 arbetstid. Det finns \u00e4ven m\u00f6jlighet att arbeta delvis p\u00e5 distans.\nL\u00e4s mer om de f\u00f6rm\u00e5ner du f\u00e5r hos oss h\u00e4r: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\/formaner-hos-oss\nL\u00e4kemedelsverket \u00e4r beredskapsmyndighet, vilket inneb\u00e4r att vi genomf\u00f6r vissa bakgrundskontroller i samband med rekryteringar. Du kommer vid en eventuell intervju att beh\u00f6va styrka din identitet samt uppvisa examensbevis och relevanta intyg. All tillsvidareanst\u00e4lld personal vid L\u00e4kemedelsverket \u00e4r krigsplacerad inom myndigheten.\nKontakt\nDu \u00e4r v\u00e4lkommen att kontakta gruppchef Anna-Karin Maltais. Du kan \u00e4ven kontakta de fackliga f\u00f6retr\u00e4darna Jonas Walld\u00e9n, Saco och Pia Wictor, ST. Vi finns alla p\u00e5 telefon 018-17 46 00 eller n\u00e5s genom e-post fornamn.efternamn@lakemedelsverket.se.\nMer om L\u00e4kemedelsverket\nDu t\u00e4nker kanske inte s\u00e5 ofta p\u00e5 L\u00e4kemedelsverket, men vi kan lova att du m\u00f6ter oss i din vardag. Resultatet av det vi g\u00f6r m\u00e4rks p\u00e5 apotek, sjukhus, hos veterin\u00e4ren och i ditt badrumssk\u00e5p. Vi ser n\u00e4mligen till att du och alla andra i Sverige f\u00e5r tillg\u00e5ng till s\u00e4kra och effektiva l\u00e4kemedel och medicintekniska produkter, allt fr\u00e5n pl\u00e5ster och graviditetstester till rollatorer och appar. Det g\u00f6r vi genom att godk\u00e4nna och ge tillst\u00e5nd, \u00f6vervaka och kontrollera och genom att informera och ge r\u00e5d. Vi som arbetar p\u00e5 L\u00e4kemedelsverket \u00e4r stolta \u00f6ver v\u00e5rt viktiga samh\u00e4llsuppdrag: att bidra till den svenska folk- och djurh\u00e4lsan.\nL\u00e4s mer om v\u00e5rt uppdrag och vad det inneb\u00e4r att arbeta p\u00e5 L\u00e4kemedelsverket h\u00e4r: https:\/\/www.lakemedelsverket.se\/sv\/om-lakemedelsverket\/jobba-pa-lakemedelsverket\nV\u00e4lkommen med din ans\u00f6kan!\nDenna rekrytering sker helt genom L\u00e4kemedelsverkets f\u00f6rsorg. Vi undanber oss d\u00e4rf\u00f6r telefonsamtal fr\u00e5n rekryteringsf\u00f6retag och annonsf\u00f6rs\u00e4ljare.","price":null,"currency":"SEK","status":"active","noindex":true,"location":{"address":null,"full_address":null,"city":"Uppsala","country":"SE","latitude":59.858562,"longitude":17.638927},"metadata":{"region":"Uppsala l\u00e4n","duration":"Tills vidare","employer":"L\u00e4kemedelsverket","postcode":"75637","positions":1,"profession":"Biomedicinare","salary_type":"Fast m\u00e5nads- vecko- eller timl\u00f6n","employer_url":"https:\/\/www.lakemedelsverket.se\/sv","scope_of_work":"100\u2013100 %","working_hours":"Heltid","employment_type":"full_time","occupation_field":"Naturvetenskap","employer_workplace":"L\u00e4kemedelsverket","experience_required":true,"employment_type_label":"Vanlig anst\u00e4llning"},"user_id":null,"is_sponsored":false,"views_count":0,"ai_views_count":4,"bot_views_count":2,"ai_vendor_counts":{"openai":2,"anthropic":2},"visibility":"public","submission_source":null,"submission_ai_name":null,"has_owner_email":true,"can_contact_owner":true,"phone":"018-17 46 00","owner_email":"fornamn.efternamn@lakemedelsverket.se","images":[],"published_at":"2026-09-14T15:16:19+00:00","expires_at":"2026-10-05T23:59:59+00:00","created_at":"2026-09-15T03:21:56+00:00","updated_at":"2026-09-18T03:23:54+00:00"}}