Investigator at the Medical Products Agency

At the Medical Products Agency, 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 want to work as an investigator and have experience in the manufacturing of biological medicines? We at the Medical Products Agency's unit for Pharmacy and Biotechnology are looking for a new colleague! Right now, we particularly want to expand our expertise in virus safety.

Our Operations

The unit for Pharmacy and Biotechnology (FoB) consists of just over 70 employees working within a broad scientific area. The unit is responsible for evaluating the documentation related to the manufacturing, characterization, and control of medicines in applications for approval. The evaluation, together with the assessment of the medicines' efficacy and safety (investigated by other units), forms the basis for decisions on whether a medicine can be approved for clinical use. The investigative work is also carried out in collaboration with other EU member states.

We are now looking for an investigator for the Biotechnology 2 group, one of the two groups that investigate applications for biological/biotechnology medicines. The group currently consists of nine employees. The focus area for the group is the assessment of biological medicines, such as blood/plasma-derived medicines, advanced therapy medicines, vaccines, and the evaluation of virus safety.

Your Responsibilities

Your main task as an investigator is to make a critical scientific and regulatory assessment of the quality of biological medicines based on the documentation of how the products have been developed, characterized, manufactured, and controlled. The evaluation is performed in teams and includes the active substance, medicinal product, and assessment of the virus safety of the applied products.

The work is varied and encompasses the entire life cycle of a product; scientific advice, clinical trials, approval of new medicines, and variation applications. The assessments are documented in investigation reports.

You will primarily work with the assessment of medicines for advanced therapies (ATMP; cell and gene therapies), vaccines, blood/plasma-derived medicines, and/or virus safety. Depending on your background, the assessment of other biological medicines, such as recombinant proteins and monoclonal antibodies, may also be included in your tasks.

The work is independent and developmental and involves collaboration both internally and with other medicinal authorities, both in matters of approval of medicines and in the development of requirements and guidelines within our area of responsibility. The extensive European collaboration may involve engagement in various expert groups.

Your Background

We are looking for someone with a scientific university or college education and several years of professional experience in a relevant field, such as cell biology, molecular biology, virology, or protein chemistry. You should have experience in process development and manufacturing of biological medicines. You should also have knowledge of virus safety and virus validation.

A doctoral degree in a relevant field and experience with pharmaceutical regulatory documentation is advantageous. Manufacturing of biological medicines on a commercial scale with development and validation of culture and purification processes is valuable experience. Experience with ATMPs, cell banks, as well as knowledge in bioinformatics is also advantageous.

The daily work requires a good ability to communicate in both spoken and written Swedish and English.

Your Personal Qualities

You have a scientific mindset, are curious and engaged, and are stimulated by working in an environment with broad scientific and regulatory expertise. You are analytical and can assimilate extensive and complex information, make rational assessments, and compile these clearly within set time frames. You are meticulous and have a good ability to work methodically and systematically. You work independently, act with integrity, and are responsible. You have a good ability to collaborate and create dialogue and team spirit. You share your knowledge and care about your own and the group's development.

We place great emphasis on personal qualities.

Good to Know

Application deadline: 2025-05-06
Employment type: Permanent
Start date: By agreement
Unit: Pharmacy and Biotechnology
Diary number: 2.4.1-2025-032253

We apply a 6-month probationary period. We value diversity and welcome applicants from different backgrounds.

At the Medical Products Agency, you will have good conditions for work-life balance. We offer you, among other things, flexible working hours, favorable vacation conditions, wellness benefits, and wellness during working hours. To the extent that the tasks allow, there is the possibility to partially work remotely by agreement with the manager.

Read more about the benefits you get with us here: Benefits with us (https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket/formaner-hos-oss)

The Medical Products Agency is a preparedness authority, which means that we conduct certain background checks in connection with recruitments. You will need to verify your identity and present your degree certificate and relevant certificates during a possible interview. All permanently employed staff at the Medical Products Agency are placed in wartime within the authority.

Contact

You are welcome to contact group manager Anna-Karin Maltais. You can also contact the union representatives Alexandra Braf, Saco and Pia Wictor, ST. We can all be reached at phone 018-17 46 00 or by email firstname.lastname@lakemedelsverket.se.

More about the Medical Products Agency

You may not think about the Medical Products Agency often, but we can promise that you encounter us in your daily life. The results of what we do are noticeable at 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, from plasters and pregnancy tests to walkers and apps. We do this by approving and granting permits, monitoring and controlling, and by informing and advising. We who work at the Medical Products Agency are proud of our important societal mission: to contribute to the health of the Swedish people and animals.

Read more about our mission and what it means to work at the Medical Products Agency here: Work at the Medical Products Agency (https://www.lakemedelsverket.se/sv/om-lakemedelsverket/jobba-pa-lakemedelsverket)

Welcome with your application! This recruitment is conducted entirely through the Medical Products Agency. We kindly ask for no phone calls from recruitment companies and advertisement sellers.