Bioarctic

Would you like to drive the analytical development of biopharmaceuticals in close collaboration with external partners? We are looking for a CMC Analytical Project Manager who wants to combine scientific and technical expertise with project management and coordination across the different stages of drug development. About the role You will drive and implement analytical development strategies for projects together with external partners. You will plan and coordinate CMC-related analytical activities, working internally with project teams and other relevant functions and externally with contract development and manufacturing organizations (CDMOs) and other suppliers. You will also work closely with the CMC Project Manager responsible for process activities. Your main responsibilities You will contribute scientific and technical expertise to a broad range of CMC-related analytical activities, primarily carried out at CDMOs. Your responsibilities will include: * Developing and driving the analytical strategy throughout all project phases. * Working on analytical method qualification and validation, method transfers and troubleshooting. * Contributing to product specifications, product characterization, comparability studies and assessment of critical quality attributes (CQAs). * Monitoring and analyzing trends in stability data. * Ensuring that analytical methods are relevant and that activities comply with cGMP. * Managing changes, deviations and risks. * Writing and reviewing CMC documentation for development studies, manufacturing campaigns, stability studies and regulatory submissions. * Supporting the identification of CDMOs and reviewing quotations and agreements. Your background We are looking for someone with: * A master’s degree in chemistry, chemical engineering, life sciences or a related field, or an equivalent qualification. * At least ten years of relevant experience in the pharmaceutical or biotechnology industry. * Expertise in biopharmaceutical process development, analytical development and manufacturing. * Extensive experience managing CDMO relationships, including cGMP oversight and technical investigations. * Proven strong leadership and project management skills. * The ability to communicate in English. Swedish is an advantage. * Experience working with antibodies is an advantage. Who are you? You take initiative and responsibility for moving work forward. Drawing on your specialist expertise and analytical skills, you understand complex issues and make well-founded judgments. You remain composed and persistent when problems arise and contribute to stable, trusting working relationships. You communicate clearly and in a structured way, share your knowledge and collaborate to achieve common goals. You thrive in a fast-paced environment and are skilled at prioritizing and coordinating activities to meet project timelines. Application Please submit your application as soon as possible and no later than 22 November 2026. Applications will be reviewed on an ongoing basis, and interviews may begin before the application deadline. If you would like to know more about the position, the team or what it is like to work at BioArctic, please contact us through our career page. Occupational psychology assessments and a background check will form part of this recruitment process. Read more about BioArctic at www.bioarctic.com This recruitment process is managed directly by BioArctic. We kindly decline contact from external recruitment agencies and vendors. Important: BioArctic never charges candidates any fees during the recruitment process. We will never ask you to pay for interviews, background checks, training, equipment or visa processing. All communication regarding this position will take place through BioArctic’s official channels. If you are unsure whether a contact is legitimate, please contact us using the details provided on BioArctic’s website.

Master Thesis Project: Developability Assessment of Antibodies At BioArctic, we combine scientific curiosity with a commitment to developing new treatments for diseases with large unmet needs such as Alzheimer’s disease, Parkinson’s disease, and ALS. As an innovative Swedish biopharma company, we offer you the opportunity to conduct your Master Thesis project in a research environment where science has a clear purpose. About the project BioArctic is offering a Master Thesis project focusing on the developability assessment of antibodies with varying molecular complexity. Developability studies are an important part of antibody discovery and development, helping to identify molecular properties that may affect stability, manufacturability, and suitability for large-scale production. Engineered and more complex antibody formats may be particularly sensitive to conditions that can lead to aggregation, structural changes, or loss of biological activity. The aim of this Master Thesis project is to investigate how different antibody molecules respond to selected forced degradation and stress conditions. The antibodies will be evaluated in different buffer conditions and exposed to stresses such as elevated temperature, oxidation, and pH extremes. What you will do During the project, you will work hands-on with antibody samples and a range of analytical methods used for protein and antibody characterization. You will plan and perform stability studies, analyze experimental data, and compare how antibodies of different complexity respond to the selected conditions. The work will include: * Planning and execution of forced degradation studies using selected antibody molecules * Evaluation of antibody stability in different buffer conditions * Exposure of antibodies to thermal, oxidative, and pH stress * Assessment of thermal stability and aggregation propensity using nano differential scanning fluorimetry (nanoDSF) * Analysis of antibody integrity and purity using capillary electrophoresis SDS (CE-SDS) * Evaluation of charge heterogeneity using capillary isoelectric focusing (cIEF) * Assessment of retained target binding using surface plasmon resonance (SPR) and/or enzyme-linked immunosorbent assay (ELISA) * Comparison and interpretation of results from the different analytical methods * Structured documentation and compilation of experimental data The overall goal is to establish a structured database describing the stability profiles of different antibodies under selected stress conditions. The results will contribute to the understanding of how antibody format and molecular complexity influence developability and may support the design and selection of future antibody candidates, as well as help identify and mitigate potential challenges before progression into large-scale production and CMC development. Who are you? We are looking for a motivated Master’s student with a strong interest in biotechnology, protein science, analytical methods, and biopharmaceutical research. You are currently studying a Master’s program in Biotechnology, Molecular biotechnology, Biochemistry, Biomedicine, Chemical engineering or bioprocessing, Protein or antibody engineering, or a related life-science discipline. Prior experience of laboratory work is highly valued. Hands-on experience with protein or antibody characterization, sample preparation, or analytical techniques such as nanoDSF, CE-SDS, cIEF, SPR or other biophysical and biochemical methods is advantageous but not required. We value a student who is curious, eager to learn, and comfortable performing experimental laboratory work. You take responsibility for your work and have a structured, methodical, and careful approach to experiments, data analysis, and documentation. You should enjoy solving problems, interpreting results, and working both independently and together with experienced scientists. About the thesis The project is suitable for a Master Thesis or equivalent degree project of at least 30 ECTS credits, corresponding to one academic semester or longer, depending on the requirements of the university program. The preferred start date for the project is 18 January 2027. The thesis work will be conducted at BioArctic in Stockholm, where you will work closely with scientists experienced in antibody engineering, protein characterization, development, and biopharmaceutical research. About BioArctic BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic’s partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport therapies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. BioArctic’s head office is located in Stockholm Sweden, and the company has more than 150 employees. For further information, please visit www.bioarctic.com. As a Master Thesis student, you will have the opportunity to work in an industrial research environment and gain hands-on experience with analytical technologies and workflows relevant to modern antibody discovery, developability assessment and biopharmaceutical development. Application Please submit your CV, relevant university transcripts and answer the questions in the application form before November 10th.

Master Thesis Project: Development of a Scalable CHO Transfection Platform for Complex Antibody Formats At BioArctic, we combine scientific curiosity with a commitment to developing new treatments for diseases with large unmet needs such as Alzheimer’s disease, Parkinson’s disease and ALS. As an innovative Swedish biopharma company, we offer you the opportunity to conduct your Master Thesis project in a research environment where science has a clear purpose. About the project BioArctic is offering a Master Thesis project focusing on the development and optimization of a scalable transient CHO cell transfection platform for recombinant antibody production. Recombinant antibodies are an important class of therapeutic molecules, and increasingly complex antibody formats create new challenges for efficient and reproducible protein production. A robust expression platform that can be applied across different antibody formats and production scales is therefore an important part of antibody discovery and development. The aim of this Master Thesis project is to develop and establish a robust and scalable transient CHO cell transfection workflow, covering culture volumes from small-scale screening in multi-well plates to 2–5 L production scale. What you will do During the project, you will work hands-on with mammalian cell culture, transient transfection and antibody production. You will optimize key parameters affecting protein expression, and evaluate how well the process translates across different culture scales. The work will include: * Optimization of transient transfection conditions in CHO cells * Expression of conventional IgG and more complex antibody formats, including multispecific antibodies * Scale-up from multi-well plate format to larger culture volumes of up to 2–5 L * Evaluation of expression levels and reproducibility * Protein A-based purification of expressed antibodies * Protein characterization to assess product purity and antibody assembly * Documentation and evaluation of the optimized workflow Depending on the scope and duration of the thesis, the project may also include Design of Experiments (DoE) approaches and optimization of antibody chain ratios. The overall goal is to establish a standardized, robust and scalable transfection protocol that can support antibody production from early small-scale screening to larger-scale protein production. Who are you? We are looking for a motivated Master’s student with a strong interest in biotechnology, protein science and biopharmaceutical research. You are currently studying a Master’s program in Biotechnology, Molecular biotechnology, Biochemistry, Biomedicine, Chemical engineering or bioprocessing, Protein or antibody engineering, or a related life-science discipline. Prior experience of laboratory work is highly valued. Hands-on experience with mammalian cell culture, recombinant protein expression, protein purification or protein characterization is advantageous but not required. We value a student who is curious, eager to learn and comfortable working experimentally in the laboratory. You take responsibility for your work and have a structured and careful approach to experimental work and documentation. You should enjoy solving problems, interpreting experimental results and working both independently and together with experienced scientists. About the thesis The project is suitable for a Master Thesis or equivalent degree project of at least 30 ECTS credits, corresponding to one academic semester or longer, depending on the requirements of the university program. The preferred start date for the project is 18 January 2027. The thesis work will be conducted out at BioArctic in Stockholm, where you will work closely with scientists experienced in protein expression, antibody engineering and protein characterization. About BioArctic BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic’s partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport therapies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. BioArctic’s head office is located in Stockholm Sweden, and the company has more than 150 employees. For further information, please visit www.bioarctic.com. As a Master Thesis student, you will have the opportunity to work in an industrial research environment and gain hands-on experience with technologies and workflows relevant to modern antibody discovery and biopharmaceutical development. Application Please submit your CV, relevant university transcripts and answer the questions in the application form before November 10th.

BioArctic AB (publ) is a Swedish research-based biopharma company with a vision of a world where science defeats severe brain diseases. Through world-leading science and strong collaborations, we create and develop innovative treatments for patients with severe brain diseases. BioArctic originated the antibody behind the world’s first treatment proven to slow disease progression in early Alzheimer’s disease and has a broad research portfolio in neurodegenerative diseases. BioArctic’s B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. Founded in 2003, BioArctic has more than 160 employees and operations across the Nordic countries. Our headquarters and main offices are located on Kungsholmen in Stockholm. Our culture is guided by our core values: Care, Challenge and Collaborate. We offer an inclusive and engaging environment where employees take responsibility, challenge established thinking, contribute diverse perspectives and work together to create meaningful impact for patients. The role The Clinical Trial Assistant (CTA) provides essential administrative and operational support to the clinical trial team to ensure the efficient execution of clinical trials in compliance with ICH-GCP, regulatory requirements, and company SOPs. The CTA works closely with Clinical Projects Managers (CPMs) and cross-functional teams to support trial start-up, conduct, and close-out activities. Role responsibilities and activities * Assist CPMs and the key members in overall trial oversight by set-up, adherence to and maintenance of the sponsor oversight plan * Support oversight of study trackers (e.g., enrollment, site status, risk log) * Coordination of meetings and meeting minutes * As needed: support the study team with tasks related to e.g. IMP supply, vendor management and overall logistics * Support invoice tracking and processing * Assist with budget tracking (as applicable) * Perform trial oversight to ensure completeness and timely updates of the Trial Master File (eTMF/TMF) * Manage archiving and document retention processes Profile and background * Bachelor’s degree or comparable level of education or work experience in life sciences, nursing, or related field * 1–3 years of experience in clinical research or clinical trials support (CTA, study coordinator, or similar) * Experience working in a sponsor company or CRO environment * Knowledge of ICH-GCP and clinical trial processes * Proficient in Microsoft Office (Excel, Word, PowerPoint) * Experience with CTMS, eTMF systems, or clinical trial tools is a bonus Core Competencies * Strong attention to detail and high-quality document management * Ability to manage multiple tasks and deadlines simultaneously * Effective written and verbal communication skills in English * Ability to work cross-functionally in a global environment * Proactive, structured, and solutions-oriented * High level of integrity and compliance mindset * Team-oriented with strong organizational skills Reporting The Clinical Trial Assistant reports to the Senior Director, Head of Clinical Operations and Medical Science and works closely with colleagues in Clinical Operations, Medical, Data Management, Regulatory affairs, Pharmacovigilance as well as with external vendors. Application Please submit your application as soon as possible and no later than 30 October 2026. Applications will be reviewed on an ongoing basis, and we reserve the right to close applications early. This recruitment process is managed directly by BioArctic. We kindly decline contact from external recruitment agencies and vendors. Read more about BioArctic at www.bioarctic.com Important: BioArctic never charges candidates any fees during the recruitment process. We will never ask you to pay for interviews, background checks, training, equipment or visa processing. All communication regarding this position will take place through BioArctic’s official channels or recruitment partners engaged by BioArctic. If you are unsure whether a contact is legitimate, please contact us using the details provided on BioArctic’s website.