Role Summary:
This position is responsible for developing and implementing technology transfer strategies, ensuring seamless execution of projects from concept to delivery.
Main Responsibilities:
* Develop and implement technology transfer strategy, including process validation and control strategy
* Lead technical gap assessments and ensure implementation of mitigation activities
* Author and review project-related documentation
* Review and approve supporting protocols and reports
* Ensure site-specific cleaning validation and media fill strategy aligns with global requirements
* Provide SME input to technical aspects of incident response
* Support regulatory audits as needed
* Implement technology transfer and validation best practices across the network
About You:
To be successful in this role, you will need 6 years' experience in providing technology transfer project support to drug substance or drug product manufacturing. A Bachelor's degree in Science or Engineering (or related field) is also required. Proven ability to manage tech transfer programs at site level and corporate level in support of GMP operations is essential.
Skills and Qualifications:
* Tech Transfer
* NPI (New Product Introduction)
* Drug Substance
* Fill Finish