OBS! Ansökningsperioden för denna annonsen har
Are you an analytical chemist with experience of Quality Control of biopharmaceutical drugs? Have you been working with tech transfer, external contract labs? Then This job opportunity is for you.
Xbrane is an innovative company developing Biosimilar products. By joining Xbrane, you will be part of a biopharmaceutical drug development company with the goal to ensure the access of biologics to an underserved patient population, enabling global health equality. Xbrane keeps on growing and is now seeking one more Analyisis Specialist and QC Coordinator in the late stage analytics team that is working with coordination and quality monitoring of analytical activities at Xbrane’s contracted QC laboratories. The team is part of the Manufacturing and Supply Department.
As Analyisis Specialist and QC Coordinator, you will coordinate the analytical laboratory operations at the contracted QC laboratories where Xbrane’s externally manufactured products are analysed. Responsibilities more in detail are:
• Plan and coordinate release testing and stability studies, as well as compiling and reporting results.
• Managing transfers of analytical methods, including sourcing of contracted laboratories, planning the activities, as well as reviewing and approving protocols and reports.
• Being responsible for validated analytical methods used for release, stability studies and manufacturing.
• Coordinate the production, storage and administration of standards/references and specific reagents.
• Manage investigations in production and analysis (OOE, OOT, OOS).
• Establish specifications.
The role will collaborate and coordinate activities with both internal and external functions such as Regulatory Affairs regarding analytical method documentation (e.g., development, validation, tech transfer) and stability documentation. And with R&D and CMOs regarding development/optimization/validation of analytical methods for clinical projects and commercial products, respectively. Therefor collaborative and coordinating skills are highly ranked for this role.
To succeed in this role, we believe that you are creative, curious and highly motivated. You are used to take initiatives, to work independently and to have several projects ongoing in parallel. You are communicative, a great team player, and enjoy creating connections both internally and externally.
In addition, you need the following qualifications:
• BSc, MSc or PhD degree in Life Sciences or related field.
• 3 years’ experience from the life science industry, e.g., development and analysis of biopharmaceuticals, and experience from QC and QA.
• Experience of bioanalytical methods, and extensive knowledge of techniques such as HPLC, Bio-Assays and ELISA.
• Experience of working in a GMP regulated environment, preferable from QC lab.
• Good communication skills in English.
Then don’t hesitate to take contact or apply. In this recruitment process, Xbrane is collaborating with Mpya Sci & Tech. Please submit your application no later than 12th of December. If you have any questions regarding the position or the recruitment process, you are welcome to contact Talent Advisors, Ellinor Crafoord email@example.com, 0721765167, Sara Andersson firstname.lastname@example.org, 0731448350.
About Xbrane Biopharma
Xbrane offers an opportunity to work with frontline analytical methods in a highly competent team. If you have a can-do attitude and on top of that share our values; Make it happen, Beat yesterday, Impossible is nothing and We win as one, you will prosper with us.
Xbrane Biopharma is a Swedish biotechnology company which develops and manufactures biosimilars. Xbrane has a patented protein production platform and world-leading expertise within biosimilar development. This is a company with an entrepreneurial spirit that focuses on being creative and coming up with new ideas as well as on following a rigorous process to bring those ideas to fruition. Xbrane’s headquarter is located at Solna Campus, just outside of Stockholm, for more information see www.xbrane.com.