This is a dynamic opportunity to work in the Technical Services team, providing process science support for new product tech transfers in areas such as Drug Substance Proteins, Drug Substance Vaccines, and Bioprocessing. The jobholder will require flexibility to move between projects or work on multiple smaller projects simultaneously.
Key Responsibilities:
* As a key member of the tech transfer team, you will support the transfers of new products and represent the site at internal and external tech transfer meetings.
* Capture all aspects of the existing process and equipment to ensure an equivalent process is transferred to the Grange Castle site.
* Execute technology transfer tasks, including Gap Analysis, Process Transfer Risk Assessment, and process description.
* Develop process validation protocols and lead their execution in conjunction with Operations.
* Generate process validation summary reports and associated filing submissions.
The ideal candidate will have a strong background in mammalian cell culture, protein purification, or validation, with experience working in a cell culture manufacturing process or technical transfer of a drug substance process to a large-scale biotech manufacturing facility. They should also possess excellent communication skills and be able to independently plan and perform work assignments.
This role offers the opportunity to work in a dynamic team environment, where collaboration and problem-solving are highly valued. If you are motivated, proactive, and persistent, with a strong desire to deliver high-quality results, then this could be the ideal position for you.
The successful candidate will have a minimum of 2-5 years' experience in a similar field, with a proven track record of delivering complex projects and working effectively in a multi-disciplinary team environment.