The job of a Senior Project Lead is to collaborate with teams of immunoassay development, product transfer, and operations, actively involved in the assay design, review and execution of immunoassay optimization and verification and validation studies, and lead successful technology transfer to production.
- Participates in multiple immunoassay development projects, interacting with colleagues across early phase assay development, product transfer, operations, instrument engineering, software, and bioinformatics.
- Works with R&D teams to gain a deeper understanding of the process challenges and actively assist in the development of standard operating procedures and technology transfer to internal and external manufacturers
- Determines strategic approach to experimental design and proposes new strategies and methods to address immediate and upcoming technical issues
- Prepares documents, including data summaries, reports, SOPs and procedures
- Troubleshoot and improve existing processes to establish a robust and reproducible product or process performance
- Interacts with other internal departments, as necessary, to plan and expedite product/technology transfer to manufacturing
- Effectively communicate with peers, colleagues and internal/external collaborators and present experimental results and analysis at R&D meetings
- Maintains a high level of expertise through scientific literature, competitor products, and seminars, and serves as technical expert within assay development groups and across other internal departments
- Provides work direction and coaching for junior-level Research Associates as needed
- Attention to detail, strong organizational skills and the ability to multi-task is required
- The candidate must thrive in a fast-paced environment and be willing to learn and apply new technology to process development
- Occasional travel may be required
- The candidate should have a Ph.D. with 8 years' experience in Biotech industry or Master's degree with 10 years' experience in the biotech industry; degree in Biochemistry or Immunology is preferred
- Strong working knowledge of immunoassay principles, excellent laboratory skills, and awareness of analytical methods in the protein and antibody field is required
- Hands-on experience in ELISA assay platform is required
- Candidate with competitive ELISA and magnetic beads based CLIA assay experience is strongly preferred
- Experience in GxP (GLP GMP) and Good Documentation Practices are required
- Bilingual in English and Mandarin would be a plus
Founded in 1992, Wondfo is a global company specializing in rapid diagnostics with laboratories in San Diego, Chicago, and twelve overseas offices. Wondfo earned a wide range of certifications from FDA CE, FSC, ISO 9001:2008, and ISO 13485:2012 quality system certification. Wondfo's sales network covers more than 140 countries and regions, providing an exciting opportunity for the distribution of quality products.
Wondfo strives to improve the quality of life and human health by developing and improving point of care in vitro diagnostic tests. At Wondfo USA's R&D site in San Diego, you will assist in designing and creating medical devices for the healthcare market. As a crucial part of a dynamic team, you will be involved in developing research ideas, executing experiments, and strategizing and developing these concepts into viable products.