On behalf of our client, Xbrane, we are now searching for a Head of Analytical Laboratory with focus on Analytical Development. Xbrane is a commercial phase Swedish biopharmaceutical company specialized in biosimilars and long acting injectables. For more information about Xbrane, please visit www.xbrane.com
As Head of Analytical Laboratory, you will be accountable for:
- Overall responsibility for analytical method package in the development of biosimilars.
- Lead the development and implementation of analytical methods for biosimilarity/comparability assessment, product lot release testing, stability testing, characterization of product degradation and establishment of reference standard.
- Set and justify specifications.
- Participate in regulatory authority communication.
- Keep up to date in the field of analytical development.
- Author analytical reports and provide data/statistical analysis to support data package for regulatory submission(s).
You have a PhD in Biology/Microbiology/Biochemistry/Biochemical Engineering/Analytical chemistry with minimum 5-10 years of experience from the pharmaceutical industry. Proven experience from common techniques for analyzing proteins, specifically primary structure characterisation, higher order structure determination, purity/impurity analysis and potency as well as experience to set up, develop and validate analytical methods and experience from comparability assessments, is required. Furthermore, you have knowledge of upstream and downstream process development for biotherapeutic proteins. For this crucial position, it is vital with working knowledge of GLP & cGMP compliance and experiences with EMA and FDA regulatory processes as well as project management experience.
By joining Xbrane you will be part of a journey to create a Swedish success story in biopharmaceutical drug development. You will report to the COO and be part of the extended management team. Since you will be initiating the Analytical Laboratory facility from scratch, employing skilled staff as subject matter experts, previous line management experience is valuable.
You have an entrepreneurial and independent personality without prestige. You are structured, flexible, calm and stress-resistant. You have a strategic and analytical mindset and a clear ambition and ability to take further steps in your career beyond this one.
The position is based at the Xbranes’s headquarter in Stockholm and the company’s in-house research and development facilities are. Minor international travelling will come with the position.
If this sounds interesting and suitable to you, please contact us today for more information or apply directly by uploading your cv and writing to us.
We look forward to your application!