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. 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 Client Delivery, Testing Operations, Quality Assurance, Process Development, Technology Development, and Manufacturing, in addition to working with colleagues in Analytical Development.
- 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. Collaborate with Process Development and client to ensure sampling plans are accurate. Coordinate with Analytical Development sub-teams, Testing Operations, and Client Delivery 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.)
- Effectively interact with clients to address testing and related questions.
Experience / Education:
- PhD in Life Sciences or related field with 5 to 10 years of experience in a biopharmaceutical or biological contract testing/manufacturing organization or
- BS/MS in Life Sciences 12+ years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
Knowledge / Skills / Abilities:
- 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.
- Ability to design and develop new assays and direct junior scientists in day to day laboratory work, as needed.
- Strong oral and written communication skills. Ability to write reports, meeting agendas/minutes, business correspondence, and procedures such as SOPs
- Strong 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
- A working knowledge of GMP guidelines is required
- Experience with Microsoft Project is a plus