Lateral Flow Scientist/Senior Scientist
MiraVista Diagnostics has an opening in the Research and Development Department for a motivated Scientist or Senior Scientist to join a team committed to Lateral Flow assay development for diagnostic products. The incumbent will be responsible for labeling antibodies with detector molecules, assembling and testing lateral flow strips, critical raw material development and method validation.
Job Responsibilities for Lateral Flow Scientist/Senior Scientist
- Conduct state-of-the-art Rapid Lateral Flow immunoassays development, including reagent screening, proof-of-concept, feasibility study, optimization, validation and final product development.
- Prepare technical SOPs as required for review and approval.
- Coordinate transfer of new assays and procedures to Production Department.
- Write GMP documents related to product manufacturing and quality assurance, progress reports, publications, SOP’s, MSDS, etc.
- Interact with staff in R&D, QA, and Regulatory Affairs.
- Ensure work is aligned with all relevant quality requirements.
- Must be able to work productively and independently in an interdisciplinary team environment.
Education and Experience
- Minimum BS in Life Sciences or a related science field; Advanced degree with experience in diagnostic industry is Preferred.
- Minimum 5 years of experience with FDA/GMP regulated medical device manufacturing.
- Lateral flow experience with a proven track of developing and launching a LF product.
- Proven ability to design, develop, and transfer IVD products.
- Experience in: GMP documents (Master Device Records, Device History Records, SOP’s); research reports/proposals; package inserts and publication manuscripts/abstracts; etc.
- Good organizational skills.
- MiraVista offers a competitive salary with a comprehensive benefits package including Medical, Dental, Vision, Life Insurance, Short- and Long-Term Disability, 401(k) Plan with company contribution and Paid Time Off.
MiraVista Diagnostics was established in 2002 and operates a fast-paced onsite clinical laboratory in Indianapolis where we process more than 100,000 diagnostic tests for serious fungal infections each year.