Xbrane is driving its first program towards launch and is also expanding the product portfolio and the Supply Chain team wants to grow. We are now searching for a Manufacturing Manager with upstream process experience, offering an exciting opportunity to be part of a cross functional team environment where you combine coordinating project activities, collaborating both within Xbrane and with external suppliers and sharing your technical expertise in biopharmaceutical manufacturing processes.
Xbrane is an innovative and growing team within the development of Biosimilars that wants to ensure the access of biologics to underserved patient populations globally. By joining Xbrane you will be part of a journey to create a Swedish success story in biopharmaceutical development. Supply Chain team is responsible for all manufacturing activities in the development programs and for future commercial products.
The team has many interactions with contract manufacturing oprganisations (CMOs) and we are looking for a colleague that can take responsibility for some of the CMO relationships and coordinate CMO activities, such as process transfer, manufacturing campaigns and process validation. In this role, you will have the day-to-day contact with CMOs, support and from time to time act as a person-inplant. Your focus will be Drug Substance manufacturing processes, and in addition to coordinating activities you will support Xbranes programs with your area of expertise. Expect intense and interesting interactions with several different suppliers and work in a cross functional team environment. You will be reporting to Xbrane’s Head of Manufacturing & Supply Chain.
WHAT YOU'LL BE DOING:
- Be responsible for planning, coordinating and following up on timelines and costs for activities internally and externally to ensure progress at the CMOs according to the project plans
- Support your colleagues as needed in especially manufacturing activities through development phases, from early clinical to commercial
- Provide technical support including document preparation and review, investigations, problem solving and input to regulatory filings
- Provide expertise and keep up to date within biologics Drub Substance manufacturing area, with specific focus on upstream process knowledge (preferably experience from both fermentation and cell culture and from different scales)
- An University degree in Life Sciences with several years of experience within the biopharmaceutical industry.
- Experience and knowledge in biologics manufacturing, preferrebly in several development phases through process development, clinical and commercial manufacturing.
- Good knowledge about requirements for manufacturing under cGMP
- Project management experience and proven ability to plan and organize your own work.
- Experience coordinating external activities and managing CMO relationships
- A natural way of creating and maintaining productive relationships both with colleagues and external contacts where collaboration and communication is in focus
- A curious and service minded attitude and have the ability to deal effectively with a variety of business areas including quality, compliance, technical development, manufacturing, and external partners/collaborators.
- Proficient in English
- You make it happen! You have the ability to drive activities independently and proactively while being part of a team where we encourage each other in a dynamic, fast-paced environment. Transparency and honesty are important to you.
- Every now and then you beat yesterday! You use a flexible, creative, pragmatic and collaborative approach ready to jump in where and when needed. You use your creativity in problem solving, you are open-minded and there is no such thing as a bad idea.
- You truly believe that impossible is nothing! You have the ability to look at a problem from alternative angles, are open to out-of-the-box solutions and have a “can do” spirit. You are brave, persistent and like turning challenges into opportunities – for each problem there is at least one solution.
- You contribute to create an environment where we win as one! Solidarity and togetherness are key to our performance and well-being. You enjoy being part of a team sharing the same values and purpose, working together, giving trust, recognition & support as we grow as one Xbrane family – at Xbrane you will never walk alone.
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 and Xbrane is
listed on Nasdaq Stockholm. For more information see [ Link removed ]