The primary responsibility is to support the process establishment and process characterization for the manufacturing of viral vectors. This position requires close interaction with the Process Sciences (PS) colleagues, Manufacturing Science & Technology, Manufacturing, Process Development, and other departments. This role will focus on defining and characterizing robust, scalable and efficient manufacturing processes to produce late-phase human clinical trial and commercial viral vector products.
The MST Associate will work closely with the MST teams to support client projects and with Brammer’s Florida site, PD, Quality, EHS, MST, and Manufacturing to ensure compliance and technology transfer.
- Supports cross functional technology transfer teams for DS manufacturing of viral vectors. Collaborate with other sites or clients to ensure success of scale up/ process transfer. Includes authoring of upstream or downstream plan documentation and associated PDPRs.
- Execute PS process establishment and process characterization runs, ensuring documentation is followed and completed real time.
- Execute cell culture or downstream laboratory work while maintaining good laboratory practice.
- Maintain an accurate schedule/project plan of assigned PS lab work and deliverables.
- Support the PS laboratory to operate efficiently. This may include maintenance of inventory; experiment and equipment use scheduling; and maintenance of equipment.
- Identifying opportunities to improve systems and practices
- Work with counterparts in Brammer’s Alachua Process Development and Cambridge Manufacturing Sciences & Technology to facilitate project success.