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.
Genezen provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
