MS&T Senior Tech Transfer Specialist
Job Summary:
In this pivotal role at {company}, you will spearhead technology transfer initiatives for clinical and commercial new product introduction projects. As a subject matter expert, you will oversee key activities and lead significant business-critical projects on-site.
Key Responsibilities:
* Develop strategies for technology transfer, process validation, and clean validation programs aligned with company, industry, and regulatory standards.
* Serve as a Process Subject Matter Expert (SME) in support of process investigations.
* Apply risk management techniques to assess strategies, prioritize activities, and drive initiatives forward.
* Lead other critical projects associated with new product introduction and site capability development.
* Act as system owner and SME to support investigations, applying risk management techniques to prioritize activities.
* Ongoing optimization of process equipment and development of breakthrough solutions.
Qualifications & Experience:
* Bachelor's Level 8 degree in a technical field (e.g., Engineering, Science, or equivalent).
* Minimum 6 years' experience in the biotechnology or pharmaceutical industry.
* 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.
* Automated systems experience highly desirable.
* Process validation and cleaning validation experience preferred.