Consultant at Warman O’Brien | Medical Affairs | UK & Europe
Analytical Development Scientist/Senior Scientist (CMC)
📢 Innovative Biotech– Sweden – Start ASAP – Office Based – Competitive Package 📢
This innovative biotech is at the forefront of pioneering advanced stem cell-based therapies, dedicated to transforming the landscape of regenerative medicine. Their cutting-edge research and development efforts focus on harnessing the potential of stem cells to create innovative treatments for a range of diseases and medical conditions. You will be part of a passionate, driven and dynamic team where innovation and collaboration are key. Are you ready to contribute to groundbreaking advancements in the cell therapy field?
🔬Key Responsibilities:
Design and execute method development and/or qualification in support of product release, product characterization, stability, in-process testing, and raw material testing
Determining product identity, purity, potency
Author and review test methods, development reports, qualification protocols and reports, and relevant SOPs
Characterize research grade and development materials to build process understanding and to develop our critical quality attributes
Perform stability studies on material generated during process development
Tech transfer developed methods and serve as analytical SME with CDMOs and CROs
Evaluate analytical data, including data generated internally and during technical review of data generated by CDMOs/CROs
🫵You will be the ideal candidate if you have:
Ph.D. in cell and/or molecular biology, biochemistry, biophysics, or another relevant field with at least 5+ years of relevant experience in analytical method development.
Experience in cell therapy, viral production, transduction, flow cytometry and conducting PCR
Theoretical understanding of stem cell biology around novel targets and pathways and/or metabolomics, genomics and proteomics to drive scientific testing and in-process monitoring of manufacturing processes
Proven experience in laboratory cellular biology techniques applied to cellular assays (including but not restricted to primary T-cell culture, flow cytometry)
Hands on experience with mammalian cell culture, aseptic techniques (experience in culture of pluripotent stem cells is highly favourable).
Working knowledge of GLP requirements and international standards pertaining to method qualification, validation, and stability.
Experience in using design-of-experiment methodologies for process optimisation is highly desirable (e.g. JUMP, DesignExpert).
Experience in techniques of Next Generation and long read Sequencing with e.g. Illumina and nanopore platform
Expertise in spectroscopic methods such as RAMAN and LC-MS is a plus
Experience managing, mentoring and engaging direct reports is preferred
If this opportunity interests you, please submit your CV to megan@warmanobrien.com to apply now. This organisation is looking to welcome the new Senior Scientist onboard as soon as possible.
Yrkesnivå
Mellannivå
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Heltid
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Vetenskap och Forskning
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Forskning inom bioteknik
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