Analytical Development Scientist/Senior Scientist (CMC)

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.