Job Description
We are currently recruiting for an exciting opportunity with a leading biopharmaceutical organization. This is an excellent position for anyone looking to join a multinational at the forefront of their field.
Duties and Responsibilities:
* Participate in and lead key technology transfers activities, supporting clinical and commercial new product introduction projects.
* Develop strategies and execute technology transfer, process, and clean validation programs aligned with company, industry, and regulatory standards.
* Serve as process Subject Matter Expert, supporting process investigations and applying 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), supporting investigations and using risk management techniques to prioritize activities and initiatives.
* Ongoing optimization of process equipment and development of future breakthrough business solutions.
Requirements:
* Experience 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.
Key Skills:
* Tech Transfer
* Drug Substance
* Biologics