Job Summary
The Lead Engineer plays a crucial role in providing technical direction for the transfer, validation, and compliant good manufacturing practices (cGMP) production of gene therapy products. This position entails a strong focus on troubleshooting operational processes, conducting thorough root cause investigations, and fostering collaboration among various departments to maintain effective manufacturing execution.
Responsibilities
- Offer technical leadership during the transfer and validation phases of gene therapy products.
- Troubleshoot and resolve issues within manufacturing processes.
- Conduct root cause analysis to identify and eliminate issues impacting production.
- Collaborate with multiple departments to assure rigorous execution of manufacturing protocols.
Qualifications
- A minimum of 5 years of relevant experience within the biotechnology sector, particularly focused on gene therapy or viral vector production.
- A degree in Engineering or a similar scientific field is preferred.
- Demonstrated proficiency in upstream process development and GMP manufacturing techniques.
