Assay Development Scientist
Fremont, CA 94538
Bayside Solutions is seeking an Assay Development Scientist to work with our client in Fremont, CA.
Assay Development Scientist
The Assay Development Scientist is a key member of the R&D Team and plays a primary role in driving the development of new diagnostic products for use in the hemostasis and coagulation clinical and home markets. S/he will successfully develop testing protocols which will translate to new instrumentation, consumables and reagent requirements, and support technology transfer to manufacturing. S/he will lead R&D projects and work collaboratively with other R&D teams (both internal and external), product marketing, manufacturing, and technical collaborators to take new assay products and applications through concept, feasibility, development, validation and commercialization.
Duties and Responsibilities
- Develop new diagnostic assays and enhance current methodologies used to study hemostasis and coagulation therapies in a clinical and Point of Care (POC) setting.
- Translate market sector requirements into the creation of new assays, instrumentation, and testing methodologies.
- Interact cross-functionally to define products, transfer new designs to manufacturing, and ensure on-time regulatory submissions. Work with R&D collaborators to generate performance qualification, method comparisons, and validation reports. Facilitate with peers and external collaborators for optimization of all aspects of the development processes for increased efficiency and effectiveness.
- Conduct experimental designs in an organized and methodical fashion. Execute research and development activities through all phases of product development.
- Plan, design and execute various scientific investigations to support enhancements to existing assays and align with company goals.
- Conduct validation tests for new assays, instrumentation and methodologies and support clinical trials as needed.
- Support assay transfer to manufacturing operations and insure successful commercialization of new assay products.
- Manage project deliverables to ensure timely project delivery. Set clear product development timelines and prioritize efforts to deliver on commitments.
- Work in the lab, design and execute studies, and perform troubleshooting. Resolve technical and workflow issues in a timely fashion.
- Manage lab inventory for new and existing projects. Train new employees.
- Record and document assay development work in the scientific notebooks for reference purposes.
- Ensure all research and development studies adhere to company and ISO13485/FDA guidelines.
- Generate reports pertaining to assay development progress and contribute to new IP as needed.
- This position will act as a resident expert for assays in development.
- Hands on experience in medical device, in-vitro diagnostics product development. Familiarity with the process of obtaining CE-IVD and/or FDA clearance/approval of In Vitro Diagnostic (IVD).
- Excellent organization, time-management, record-keeping, interpersonal and communication skills are essential.
- A self-motivated individual that is detail-oriented, excels at problem solving and can function both independently as well as part of a team is required.
- Must be able to work and contribute to a highly collaborative and fluid environment on multiple projects concurrently.
- Applicants should minimally hold a B.S./B.A. in a life science discipline with 8+ years’, M.S. with 5+ years’, or a Ph.D. with 3+ years’ experience, preferably in medical device and in-vitro diagnostics.
- Experience in commercial blood chemistry diagnostics, automation, and statistical evaluation of clinical data sets is highly desirable. Working knowledge of coagulation chemistries and assays a definite plus.
- Understanding of Quality Systems Regulations and cGMP product development a plus.