As a Senior Scientist in our Technology Development department, you will be part of a dynamic team leading assay development projects as well as acting as a technical project manager. You will primarily be responsible for developing in process and release testing strategies that meet federal agency requirements for various internal and external manufacturing programs for cell and gene therapy products. Furthermore, you will lead development and transfer of assays that are needed to characterize and release cell and gene therapy products. This position requires continual interaction and collaboration with Clients as well as WuXi AppTec internal departments such as Project Management, Testing Operations, Quality Assurance, Process Development and Manufacturing.
Provide guidance to internal and external customers on appropriate testing strategies and sampling plans for cell and gene therapy clients.
Stay current in the field of cell and gene therapy regulations with respect to both testing and manufacturing guidelines.
Serve as a core team member on multiple manufacturing teams and serve as the Analytical lead. Partner with Process Development and client to ensure sampling plans are accurate. Coordinate with Technology Development sub-teams, Testing Operations, and Project Management to ensure analytical timelines stay on track. Continually communicate accurate timelines to core team leads and project management.
Design, conduct and coordinate assay development projects from inception to completion for the development of new assays needed to support manufacturing and testing programs.
Conduct critical review of results and report data to management and project teams. Effectively present detailed data to clients on teleconferences and face to face routinely.
Write research and development reports and ensure all data is represented clearly and accurately.
Author assay qualification and validation protocols and reports.
Prepare and revise technical documents (Laboratory Protocols, SOPs, etc.)
Demonstrate exceptional written and oral communication
Effectively interact with clients to address testing and related questions.
Author abstracts and present at scientific meetings, as needed.
Author risk assessments, as needed.
A PhD in Life Sciences or related field with 5 to 10 years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
Thorough knowledge of FDA regulatory guidance documents and EU regulations with respect to testing requirements for Cell and Gene Therapy products.
Experience developing and defending testing strategies for biological products.