Vacant job

Scandinavian Biopharma is a research-based biotech company committed to helping people around the world achieve a better and longer life. They are well on their way to doing so through the development of the world's first vaccine against ETEC bacteria. ETEC infections can be severe in both children and adults, leading to severe diarrhea. The most vulnerable are small children who can suffer lasting effects and even die as a result of the infection.

Scandinavian Biopharma also distributes a wide range of biological specialty medicines, focusing on vaccines and immunoglobulins, primarily in Northern Europe.

Currently, Scandinavian Biopharma already has promising safety and efficacy data for ETVAX from the phase 2b study involving Finnish travelers to Benin, West Africa. We have vaccinated 5,000 children in a phase 2b study in Gambia and are currently preparing for an efficacy study (phase 3) in the USA and a large efficacy study in Zambia (phase 3). SB is well-funded by both international government grants and through Scandinavian Biopharma's own distribution operations.

Scandinavian Biopharma is now strengthening its Manufacturing team and is looking for a dedicated and experienced Drug Substance Specialist who wants to be part of the journey to have a commercially available ETEC vaccine on the market soon. The Manufacturing team works exclusively with external manufacturing and is responsible for collaboration with global CMO networks for the production of the company's pharmaceutical products.

In the role of Drug Substance Specialist, you will play a key role in the manufacturing and scaling up of our 6 Drug Substance components that are part of our ETEC vaccine, which is in the late development phase. The work includes Technology Transfer of manufacturing to our contract manufacturers (CMOs), coordinating process development work, and ensuring the production of clinical materials.

The role involves extensive collaboration externally with CMOs and also internally with colleagues in the Manufacturing, Development, Regulatory, and QA departments.

Key responsibilities:

• Tech Transfer.
• Process validation.
• Writing and reviewing manufacturing methods, validation protocols, and other production documentation.
• Writing reports for product and production of biotechnological substances.
• Building good and long-term relationships with partner CMOs.
• Compiling and evaluating results from production at CMOs.
• Writing/reviewing regulatory documents included in CMC.
• Contributing with the Manufacturing team to ensure that Drug Substance production at CMOs is efficient and compliant with GMP.
• Supporting process validation that is outsourced to CMOs, which may involve travel.

We are looking for someone who thrives in an entrepreneurial-driven company and in a role that combines practical work with more overarching strategic tasks. You are meticulous, have integrity, but are also unpretentious in your collaborative approach and take ownership. You enjoy cross-functional collaboration within the organization and are driven to create results and ensure good processes for external manufacturing.

You will be offered a responsible job in a stimulating environment with a high ceiling and become part of a group of ambitious and skilled colleagues who enjoy their work!

· University degree in Biotechnology Engineering, Pharmacy, Biochemistry, or similar scientific education.

· Several years of experience in cultivation and purification within pharmaceutical manufacturing.

· Experience working with CMOs.

· Experience in cGMP manufacturing of biological drugs and vaccines.

· Good communication skills in both spoken and written English and Swedish.

The position is full-time and reports to the VP of Manufacturing, with the office located in Solna.

In this recruitment, Scandinavian Biopharma collaborates with SallyQ. If you are interested in the position and would like more information, please contact Ellinor Crafoord, Senior Recruitment Consultant, at 079-3554257 or ellinor.crafoord@sallyq.se.

Application deadline: April 30, 2025, but selection and interviews are ongoing, so we welcome your application today.

We are entrepreneurs and experts in global vaccine development, manufacturing, registration, and commercialization of biopharmaceutical products. Our work environment is characterized by our core values where teamwork, talent, and personal development are actively promoted. We are world leaders in diarrhea vaccines against ETEC.

At Scandinavian Biopharma, we are a close-knit team with a good community and an exciting journey ahead – we hope you want to join us on this journey!