Senior Scientist CMC Development
Core
Develop, optimize, and transfer manufacturing processes for advanced therapy medicinal products (ATMPs) including cell and gene therapies.
Role type
Senior Scientist CMC Development
Builds
Manufacturing processes and analytical methods for ATMPs
Domain
Biotechnology / Cell and Gene Therapy / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process development, cell culture, gene engineering, downstream processing, cryopreservation, analytical method development, project management, technical documentation, regulatory compliance
Preferred skills
Immuno-oncology, CAR-T workflows, automated cell processing systems, scale-up activities
Technologies
Cell culture systems, gene engineering tools, analytical instrumentation, automated cell processing systems
Responsibilities
Plan and execute process and analytical development activities for ATMP manufacturing; Design and perform experiments related to cell culture, gene engineering, downstream processing, and cryopreservation; Analyze experimental data to identify trends and solve technical challenges; Support development and qualification of analytical methods; Collaborate with research, development, quality, and manufacturing teams; Contribute to technology transfer and scale-up; Prepare technical documentation including protocols, reports, and SOPs; Ensure compliance with quality standards and regulatory requirements; Manage projects for clients and collaborators.
Seniority
Senior, hands-on IC
