Expert responsible for HCP Strategy
Affibody is looking to recruit a coworker with strategic responsibility for analysis of process related impurities, such as host cell proteins (HCP), in Affibody’s In Vitro Pharmacology (IVP) group.
The scientist will be part of the IVP group, currently consisting of ten coworkers, and will be responsible for analysis of process related impurities during process development, and for testing strategies from early research to late development stages. The work will be performed in collaboration with the CMC project leads and CROs and CMOs.
The IVP group is scientifically and technically responsible for cell-based and/or immunoassays for i) characterization of Affibody® molecules in terms of binding/blocking capacity and function, ii) binding and potency assays, iii) impurity profiles, iv) immunogenicity assessments, and v) pharmacokinetic (PK) and pharmacodynamic (PD) analyses. This includes responsibility for supporting the internal research process with the development of new Affibody® molecule candidate drugs, as well as supporting Affibody’s process development, non-clinical, clinical, and post-marketing activities with method development, analyses, and subject matter expert (SME) competence in technology transfer to contract research organizations (CROs) and contract manufacturing organizations (CMOs), including support with development, qualification, and validation by CROs and CMOs. The work is conducted in close collaboration with other relevant groups at Affibody.
The position is combining laboratory work with strategic responsibility. Focus is on supporting process development, from CD selection to late clinical development, with HCP-ELISA development and analysis, host cell DNA analysis with qPCR, and transfer of assays to CRO/CMOs. In combination with strategic responsibility for selecting commercial HCP kits, develop process specific ELISA methods, characterization of immunoassay reagents and when and how to apply LC/MS analysis. You are expected to independently plan and execute research, analyze data, and report results to meet specified timelines and objectives.
The position is full-time and based in Affibody’s premises at Karolinska Institutet Campus, Solna. We interview candidates continuously and welcome your application today!
About the position
As a scientist in the IVP group, your main responsibilities include:
• Plan and execute research, analyze data, report results, and draw conclusions from analysis of process related impurities, independently or in cooperation with other group members.
• Responsibility and accountability for generated results and given timelines.
• Responsibility for documentation and reporting findings within given timelines.
• Evaluation and analysis of samples from process development of Affibody® molecules.
• Strategic overview regarding analysis of process related impurities in collaboration with the CMC group.
• Strive to increase the company’s knowledge within the field of analysis of HCP and other process related impurities.
The right candidate fulfills the following qualifications:
• University or PhD degree in Life Sciences, e.g., immunology, biotechnology, or similar.
• More than five years of hands-on experience from working with HCP assay development, preferably in an industrial setting.
• Extensive experience in independently planning and performing experiments and analyzing data in a scientific research setting.
• Experience in quantifying host cell DNA with qPCR.
• Industrial experience from the development of biologics is an advantage.
• Experience from documentation in electronic lab books is a plus.
• Verbal and written communication skills in English.
We are looking for a person with a genuine interest to seek knowledge and learn as well as with an ability to analyze, absorb and generate new ideas to solve problems and deliver innovative solutions. To succeed in the position, you need to have an interest in practical laboratory work in combination with having a strategic oversight. We believe you are driven, able to take initiative, results-oriented, and self-motivated, with a strong sense of personal accountability, working well both independently as well as in teams. The position requires good communication and interaction skills.
About the organisation
Affibody is a Swedish biotechnology company developing next generation biologics based on the company’s unique proprietary technology platform.
Affibody aims to improve the lives of patients with serious diseases. We focus on indications and target proteins where our technology platform gives us a competitive advantage and where there is a high unmet medical need in well-defined patient populations. We run pre-clinical and clinical development programs in autoimmune diseases and oncology. To learn more, please visit: www.affibody.se