Principal Scientist - Cell Sciences

Job Description

Legend Biotech is seeking a Principal Scientist to join their Technical Development team. This role focuses on cell sciences and the sourcing of cellular starting materials for allogeneic and autologous cell therapy products. The Principal Scientist will be responsible for the technical onboarding of clinical sites, conducting site evaluations and audits, and drafting technical reports. They will also support the sourcing of patient apheresis material and the development of new allogeneic cell starting material technologies.Role involves:

• Partnering with cross-functional teams to evaluate clinical apheresis centers.
• Performing audits and developing technical reports for clinical apheresis centers.
• Acting as a subject matter expert for apheresis collection and cold chain logistics.
• Authoring and reviewing GMP investigations related to clinical site deviations.
• Leading the establishment of donor eligibility criteria.
• Managing GMP donor screening and processing sites.
• Developing strategies for testing apheresis and other starting materials.
• Overseeing the development of cell lines.
• Collaborating with internal quality representatives to ensure GMP practices.
• Coordinating, authoring, and reviewing technical procedures, SOPs, and reports.

Requirements:

• Minimum 8 years of experience in cell and gene therapy or a clinical setting.
• 3+ years of experience working with cellular starting material development.
• Experience sourcing PBMCs, leukopaks, and cord blood is a plus.
• Knowledge and experience working under cGTP/cGMP guidelines.
• Expertise in problem-solving and decision-making.
• Strong presentation and verbal communication skills.
• Understanding of cell starting material, cell biology, and/or CAR-T development/processing.

Role offers:

• Opportunity to work in Technical Development team.
• Chance to work with allogeneic and autologous cell therapy products.