Our client, a biotech scale-up company at the centre of CAR-T therapy development, dedicated to advancing cutting-edge solutions that transform the treatment of cancer, are searching for a highly motivated QC Specialist to join their dynamic team as they expand on their Swiss operations.
Key Responsibilities:
- Quality Control: Perform routine and non-routine quality control testing on CAR-T therapy products to ensure they meet quality standards and specifications.
- Instrumentation: Operate and maintain specialized laboratory equipment and instrumentation, ensuring accuracy and reliability.
- Documentation: Maintain meticulous and organized records of all quality control tests and results, in compliance with regulatory requirements.
- Data Analysis: Analyze test data and report any deviations or discrepancies, initiating investigations and corrective actions as needed.
- Compliance: Ensure strict adherence to regulatory standards, including GMP, GLP, and ISO, and actively participate in regulatory inspections.
- Method Validation: Collaborate in the development and validation of new testing methods for CAR-T therapy products, as well as improvement of existing methods.
- Troubleshooting: Identify and resolve issues related to quality control processes, equipment, or materials, ensuring the highest level of product quality.
- Training: Train and mentor junior QC technicians in quality control procedures and techniques specific to CAR-T therapy.
Qualifications:
- Bachelor's or Master's degree in a relevant life sciences discipline.
- Minimum of 4 years of experience in quality control within a biotech or pharmaceutical setting, with a strong preference for CAR-T therapy experience.
- Comprehensive knowledge of regulatory requirements and quality standards, including GMP and ISO.
- Proficiency in operating and maintaining specialized laboratory equipment.
- Strong analytical skills and problem-solving abilities.
- Keen attention to detail and excellent documentation skills.
- Ability to work effectively in a collaborative team environment.
Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.
?: +41 (0) 44 5514 407
?: c.kelly@panda-int.com