Documentation & Quality

• Prepare and review development protocols, reports, SOPs, and technical and regulatory documentation.
• Maintain accurate and traceable experimental records in accordance with data integrity and quality requirements.
• Contribute to deviations, CAPAs, change controls, and other quality system activities as required.
• Promote high standards of safety, quality, and compliance.

Scientific & Technical Experience

• PhD in a relevant life science discipline with 3+ years of relevant cell therapy/ATMP experience, or BSc/MSc with 5+ years of relevant experience.
• Industry experience within biotech, pharma, or a related environment.
• Strong experience in cell therapy/ATMP process development, including cell culture, genetic modification, formulation, and processing.
• Good understanding of GMP/GLP and relevant regulatory requirements.
• Experience with process optimisation, including QbD and statistical approaches such as DoE.
• Hands-on experience with closed or automated cell processing systems; scale-up/scale-out experience advantageous.
• Experience preparing technical, CMC, and regulatory documentation.
• Experience supporting technology transfer to manufacturing partners or GMP sites.
• Experience working with primary human cells and relevant analytical or functional assays.
• Familiarity with quality systems, including deviations, CAPAs, and change controls.

Scientific & Problem-Solving Skills

• Strong analytical and problem-solving capability, with the ability to interpret complex data and draw clear conclusions.
• Able to proactively identify and resolve scientific and technical challenges.
• Demonstrates sound scientific judgement when selecting methods and approaches.
• Able to communicate technical concepts clearly and support the development of colleagues through knowledge sharing and training.
• Experience contributing to regulatory submissions is advantageous.

Planning & Communication

• Able to manage multiple priorities and experimental activities while delivering against agreed timelines.
• Strong written and verbal communication skills, with the ability to present scientific findings to technical and broader audiences.
• Effective collaborator across multidisciplinary teams and external partners.

Professional Attributes

• Hands-on, proactive, accountable, and results-oriented.
• Collaborative approach with strong interpersonal and communication skills.
• Demonstrates scientific integrity, sound judgement, and high standards of data quality.
• Committed to continuous learning, development, and high-quality scientific execution.

Digital & Data Skills

• Proficient in Microsoft Office.
• Experience with scientific data analysis and visualisation tools such as GraphPad Prism, JMP, or FlowJo.
• Familiarity with electronic laboratory notebook (ELN) systems.