As a Senior Scientist in our Technology Development department, you will be part of a dynamic team acting as a technical project manager for viral clearance / virus vector development and production related activities including assay development. You will be primarily responsible for interactions with both external biologics clients and internal departmental clients, managing proposal and protocol development as well as method transfers along with operations and the client’s technical teams. You will work closely with the WuXi AppTec Viral Clearance team to provide regulatory guidance over the course of Viral Clearance studies for various product-types and at all stages of clinical use. In addition, some interaction with the Process Development and Manufacturing teams is anticipated to coordinate and optimize the transfer / development of test methods required to support the release of client gene and cell therapeutic products.
Stay current on knowledge of viral clearance regulations with respect to both biologics and tissue industries to ensure study designs that allow for study acceptance from Phase I through Commercial processes
Evaluation of purification processes to assist in the development of viral clearance study designs to ensure regulatory acceptance
Evaluation of viral clearance study data to assess the suitability of the process used
Develop new techniques and assays for quantifying / improving virus stocks (purity, quality, potency)
Provide testing program support for various gene and cell therapy projects.
A PhD in Life Sciences or related field with 5 to 10 years of experience.
Thorough knowledge of FDA regulatory guidance documents and EU regulations with respect to Viral Validation / Viral Clearance
Protein / Viral Purification Process Development experience required
Previous CRO or biopharmaceutical company experience is lily preferred
A working knowledge of GLP/GMP guidelines is a plus
li oral and written communication skills. Ability to write reports, meeting agendas/minutes, business correspondence, webinars and procedures such as SOPs
li organizational skills with the ability to multi-task and prioritize assignments
Excellent critical thinking and problem solving abilities
Ability to effectively manage multiple projects under short time lines
Ability to work under pressure and effectively lead in a fast-paced, dynamic technical environment
Ability to be flexible and work in cross-functional teams
Occasional travel to client sites and industry meetings is required