OBS! Ansökningsperioden för denna annonsen har
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Arbetsbeskrivning
Are you experienced within drug products and looking to join a small innovative company? This is an exciting opportunity for you to join Xbrane Biopharma AB in Solna, a company developing Biosimilar products to make drugs accessible to less privileged populations globally!
Now you have the opportunity to join an innovative and growing team within the development of Biosimilars. We are recruiting a Senior Manufacturing Manager - Drug Product. In this role you will focus on Drug Product in late stages of the biosimilar product development and commercialization. This includes CMO management and oversight, coordination of internal and external activities during tech transfer of manufacturing processes from development to commercial scale, process validations and preparations for product launches world-wide.
About the position and you
In this position you will participating in defining requirements and processes for drug products and combination products (medical devices) to meet market criteria. You will be the key person for the relationship with the CMO’s where you will support the ongoing projects and the successful product launch. You will also act as the SME for the product, proving technical support including document review, trending of process data, review of technical investigations and validations. You will also support with information for the registration of the new product.
To thrive in this position you have the ability to work proactively and independently while being part of a team in a dynamic, fast-paced environment where you encourage each other. You use a flexible, creative, pragmatic and collaborative approach ready to jump in where and when needed. You also 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 and when you look at a problem, you see an opportunity. You enjoy being part of a team sharing the same values and purpose, working together, giving trust, recognition & support.
Qualification
• University degree in Life Sciences with several years of experience within pharma industry.
• Experience drug product manufacturing, preferably biological products.
• Project management experience, including coordinating external activities and managing relationships with contractors
• Experience within tech transfer and process validation
• Experience from working under GMP requirements
• Proficient in English
Interested?
In this recruitment process, Xbrane Biopharma is collaborating with Mpya Sci & Tech.
Please submit your application below, no later than the 15rd of January.
Interviews will be scheduled continuously. Questions? Please contact Linnéa Andersson, +4670 888 65 77 or linnea.andersson@mpyascitech.com.
About Xbrane
Biological drugs have revolutionized the treatment of many serious diseases such as cancer, rheumatoid arthritis, psoriasis and macular degeneration. The only problem is that they are so expensive that only a fraction of those affected can be treated with them. Our purpose is to make biological drugs accessible to everyone who needs them. For more information see www.xbrane.com.