Senior Assay Development Scientist
Company: Coagusense Inc.
Posted on: May 16, 2022
SUMMARY The Sr. Assay Development Scientist is a key member of
the CoaguSense 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. ESSENTIAL 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
coagulation-based assays, instrumentation, and testing
- 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
- 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
- Lab manager for new and existing projects, oversee junior
R&D staff members and 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 and responsible for project lifecycle deliverables.
- Ph.D. with 6+ years' experience directly in medical device and
in-vitro diagnostics assay development is required. Successful
applicants should hold a degree in a life science discipline
(Chemistry, Biochemistry, Biophysics, Molecular Biology,
Bioengineering or closely related disciplines).
- Hands on experience and demonstrated track record in medical
device, in-vitro diagnostics assay development. Familiarity with
the process of obtaining CE-IVD and/or FDA 510K clearance/approval
of In-Vitro Diagnostic (IVD) assay products.
- Experience in commercial blood chemistry diagnostics,
quantitative assay development, consumables design, reagents
development, and statistical evaluation of clinical data sets is
required. Working knowledge of coagulation chemistries and assays
(PT/INR, ACT, aPTT, Fibrinogen) is highly desired.
- 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.
- Understanding of Quality Systems Regulations, ISO13485 and cGMP
product development is required.
Keywords: Coagusense Inc., Fremont , Senior Assay Development Scientist, Other , Fremont, California
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