Non-Clinical Senior Scientist
Mpya Sci & Tech AB / Biomedicinjobb / Stockholm
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hela Sverige Xbrane is currently searching for a Senior Scientist with clinical pharmacology expertise in biologics and bioassay experience to join the 'Non-clinical' team as soon as possible. This is an opportunity for a driven, experienced individual to become a part of a Swedish success story in biopharmaceutical drug development, increase access to biologics for underserved patient populations, and ultimately help enable global health equality.
The position
As a Non-clinical Senior Scientist, you will be a new biosimilar development program core team member and Subject Matter Expert (SME), reporting directly to the Head of Non-clinical.
For projects entering clinical phase, you will oversee the development of methods to support clinical bioanalysis (PK, ADA, and Nab), monitor ongoing studies, and ensure timely documentation preparation. Moreover, for projects at a pre-clinical stage, you will also provide input on the development of bioassays intended to characterize Xbrane's biosimilars with respect to their potency.
The roles main responsibilities include the following:
• Managing projects and technical-scientific collaborations with Contract Research Organizations (CRO) to develop, validate, and maintain biological assays and bioanalytical methods.
• Directly report on project progress to the Head of Non-clinical and Management, including preparing oral presentations and written reports.
• Contribute actively to collaborations on inter-departmental and inter-company project teams.
• Participate and drive interdisciplinary technical-scientific collaborations within ad hoc teams that aim to solve issues emerging in the biosimilar development programs by contributing expert knowledge of target biology and associated indication(s).
• Support regulatory activities, e.g., drafting briefing books for scientific advice, IMPDs, and marketing authorization dossiers.
• Actively review developmental, analytical, and manufacturing documents and ongoing projects' non-clinical and clinical study documentation.
• Keep up to date with recent developments within the biosimilar field, focusing on methodologies and analytical technics for bioanalysis.
Your profile
• Ph.D. degree, equivalent work experience in Clinical Pharmacology of biologics or related field within Life Sciences, preferentially specializing in monoclonal antibodies.
• Demonstrable strong expertise in developing and troubleshooting biological assays and bioanalytical methods.
• Experience working with CROs.
• Expertise in qualification/validation of bioanalytical assays (PK and immunogenicity).
• Previous experience developing biotechnology-derived medicinal products and experience working in a GxP-regulated environment.
• Experience in writing regulatory documents.
To be successful in this role, you must be highly motivated, flexible, creative, and organized. You must also be able to plan and work independently and collaboratively while providing vital support to the team within your expertise.
You make it happen! You drive activities independently and proactively.
You beat yesterday! You use a flexible, creative, pragmatic, and collaborative approach.
You truly believe that impossible is nothing! You have a "can do" spirit, are brave, persistent, and like to turn challenges into opportunities.
You contribute to an environment where we win as one! Solidarity and togetherness are key to our performance and well-being.
What we offer
• You will be working with the development and commercialization of products in the fast-emerging field of biosimilars
• You will be able to contribute with your experience and expertise in a changing environment and will have the opportunity to learn and develop in your role as Xbrane grows
• You will be part of a strong, dynamic team and will have exciting days at work
About Xbrane Biopharma
Xbrane Biopharma is a biotechnology company that develops and manufactures biosimilars. Xbrane has a patented protein production platform and world-leading expertise in biosimilar development. Xbrane's headquarters is located in Solna, just outside Stockholm, and the company has research and development facilities in Sweden and Italy. For more information, see
www.xbrane.comInterested?
In this recruitment process, Xbrane Biopharma is collaborating with Mpya Sci & Tech.
Please submit your application no later than the 21 of May. We work with ongoing selection so don 't hesitate to apply via
www.mpyascitech.com as the position may be filled before last day of application. If you have any questions, please contact Talent Advisor Britta Granath, +46739644221,
britta.granath@mpyascitech.com.
Ersättning Enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-05-21
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Mpya Sci & Tech AB (org.nr 559210-7204)
Arbetsplats Mpya Sci & Tech
Jobbnummer 7718499
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