Investigator Biotechnology with Focus on Advanced Therapy Medicinal Products (ATMP)

Läkemedelsverket · Vollzeit

Uppsala, Schweden

At Läkemedelsverket, 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. Do 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! Our Operations The 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. Our 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. Your Tasks Your 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. Your Background We 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. It is meriting if you also have experience with: Research education in a relevant area Experience in process development and characterization of ATMPs Previous work with pharmaceutical regulatory documentation Previous work with development/validation of analytical test methods Experience with bioinformatic analyses Your Personal Qualities You 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. We place great importance on personal qualities. Good to Know Application Deadline: 2026-10-05 Employment Form: Permanent Start Date: By agreement Unit: Pharmaceuticals and Biotechnology File Number: 2.4.1-2026-074312 We apply a 6-month probationary period. We value diversity and welcome applicants from different backgrounds. At Läkemedelsverket, 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. Read more about the benefits you receive from us here: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss Läkemedelsverket 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 Läkemedelsverket are allocated for civil contingency within the agency. Contact You are welcome to contact group manager Anna-Karin Maltais. You can also contact the union representatives Jonas Walldén, Saco and Pia Wictor, ST. We are all available at telephone 018-17 46 00 or can be reached by email [email protected]. More About Läkemedelsverket You may not think about Läkemedelsverket 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 Läkemedelsverket are proud of our important societal mission: to contribute to Swedish public and animal health. Read more about our mission and what it means to work at Läkemedelsverket here: https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket We look forward to your application! This recruitment is conducted entirely by Läkemedelsverket. We therefore decline phone calls from recruitment firms and advertising sales representatives.