Job Title: MS&T Senior Tech Transfer Specialist
Summary
We are seeking a highly skilled and experienced MS&T Senior Tech Transfer Specialist to join our team. The ideal candidate will be responsible for leading key technology transfers activities, supporting clinical and commercial new product introduction projects.
Responsibilities
* Develop strategies for and support the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.
* Act as Process Subject Matter Expert in the support of process investigations.
* Use risk management techniques to assess strategies, prioritize activities and initiatives.
* Lead significant business-critical projects on site associated with new product introduction and site capability build.
* Act as System Owner and Subject Matter Expert (SME) to support investigations and use risk management techniques to prioritize activities and initiatives.
* Ongoing optimization of process equipment and development of future breakthrough business solutions.
Qualifications & Experience
* Bachelor's Level 8 degree in a technical field (e.g. Engineering, Science or equivalent).
* Minimum of 6 years in a biologics drug substance environment.
* Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
* Experience in technology transfers for clinical or commercial biologics strongly desired.
* Experience with automated systems highly desired.
* Process validation and cleaning validation experience desired.
The successful candidate will possess excellent technical skills, strong communication and project management abilities, and a proven track record of delivering results in a fast-paced environment.