Scientist
- Lead the development of automated manufacturing processes, including cell selection, activation, expansion, and harvest.
- Design, execute, and interpret complex process development experiments.
- Author, review, and coordinate technical documents, protocols, and reports.
- Analyze and present data in a clear and concise manner.
- Ensure GMP compliance in laboratory notebooks, protocols, and reports.
- Collaborate with internal and external partners to evaluate, develop, and implement new process technologies.
- Author technical documents to support regulatory filings.
- Conduct technical discussions & meetings with internal stakeholders including procurement, quality, development and finance, and facilitate implementation of new automated processes.
- Provide technical leadership and mentorship to junior team members.
- Design and execute proof-of-concept experiments to demonstrate feasibility of new technologies or processes.
- Generate and analyze data to demonstrate compatibility of new technologies or processes with existing manufacturing systems.
- Lead technology transfer activities to ensure successful implementation of new processes or technologies in GMP manufacturing environments.
- Makes independent decisions regarding routine laboratory execution, minor troubleshooting, and data analysis within approved study protocols. Guidance is sought from senior team members for experimental design, major troubleshooting steps, and changes to validated processes.
- 3-5 years of experience in MSAT, process development, or a related field.
- Strong expertise in cell therapy, automation, and bioprocessing.
- Excellent leadership, communication, and project management skills.
- Experience with technology transfers, GMP manufacturing, and regulatory filings.
- Ability to work effectively in a fast-paced, dynamic environment.
- Knowledge of automation technologies, including but not limited to:
- Experience with GMP implementation, including but not limited to:
- GMP regulations and guidelines.
- Quality management systems.
- Process validation and verification.
- Experience with CAR-T cell therapy or similar cellular therapy products.
- Knowledge of regulatory requirements for cellular therapy products.
- Familiarity with design of experiments (DOE) and statistical process control (SPC).
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