Are you ready to take your career to the next level and contribute to the development of cutting-edge cell therapies? Our rapidly growing biotech company based in a world-class research facility in Cambridge, UK, is seeking a Senior Scientist in GMP Analytical Development to join our team. Reporting to the Associate Director, QC & GMP Analytical Development, the successful candidate will play a vital role in the development and adaptation of characterisation and release assays for our first clinical cell therapy candidate.
Why apply
The company has a multidisciplinary approach that brings together experts in fields such as synthetic biology, cell biology, and gene editing, with the goal of developing cutting-edge therapies that can be translated to the clinic.
The company also has a strong focus on developing diseases such as cancer, genetic disorders, and degenerative diseases, which are some of the most challenging and unmet medical needs.
In addition to this, the company has a strong focus on orphan diseases. These are often neglected by pharmaceutical companies as they don't make a lot of profit, but as a biotech, this company can focus on finding solutions for these diseases as well.
Key Responsibilities:
- Develop and execute the strategy for the GMP analytical development function to align with business priorities and achieve the company's clinical cell therapy goals
- Lead the development of multiple assays for QC release and characterization testing for a novel engineered cell therapy, utilizing techniques such as flow cytometry, ddPCR, and ELISA-based methods
- Design and conduct experiments to advance process and analytical development knowledge, utilizing principles of design of experiments (DOE) as appropriate
- Partner with translational medicine, research, and process development teams to adapt assays for QC and in-process testing
- Author SOPs and method development reports for method transfer
- Collaborate with cross-functional teams for CTO and/or CDMO selection, assay transfer, and relationship management
- Hire, coach, mentor and train direct and indirect reports to build a high-performing analytical development team
- Interface with quality and regulatory teams to ensure compliance with current regulations and guidance in the testing approach
Education and Expertise:
- Experienced CMC professional with a minimum of 8 years industry experience, including at least 5 years of developing assays for advanced therapies
- Cell & gene therapy experience is a plus
- Advanced degree in life science and/or engineering is desired
Desired Skills:
- Experience in the development of flow cytometry and cell-based assays, specifically for cell therapy
- Experience in the development of ddPCR/qPCR and/or ELISA-based assays is a plus
- Experience in method development and qualification, including writing and reviewing method SOPs, qualification protocols, and reports
- Experience managing a laboratory-based team
- Experience managing external vendors
- Strong organizational and documentation skills
Additional Experience and Knowledge:
- In-depth understanding of GxP principles and regulations
- Knowledge of quality compliance standards and risk management
- Strong analytical, organizational, and leadership skills
- Excellent written and verbal communication skills
- Proven ability to troubleshoot, identify root causes, and systematically resolve problems
- Industry experience developing methods for QC testing of advanced therapies
Not only will you be at the forefront of the biotherapeutic industry, but you will also have the potential to manage a high-performing analytical development team. Apply now and unleash your potential!