We are seeking a highly skilled Biopharmaceutical Process Development Specialist to join our team. This is an exciting opportunity for a professional who wants to work in the biopharmaceutical industry.
Job Description:
This role involves participating in and leading key technology transfers activities, supporting clinical and commercial new product introduction projects. It also involves developing strategies for and executing technology transfer, process and clean validation programs according to company, industry, and regulatory standards.
Key Responsibilities:
* Participate in and lead key technology transfers activities, supporting clinical and commercial new product introduction projects.
* Develop strategies for and execute technology transfer, process and clean validation programs according to company, industry, and regulatory standards.
* Act as a process Subject Matter Expert, supporting process investigations using risk management techniques.
* 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, prioritizing activities and initiatives using risk management techniques.
* Continuously optimize process equipment and develop 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 highly desirable.
* Experience with automated systems highly desired.
* Process validation and cleaning validation experience desirable.
This role requires someone with strong technical skills and experience in biopharmaceuticals. If you are passionate about working in this field, please apply now.