Covaxx, a subsidiary of the UBI Group, has joined the fight against COVID-19 and is rapidly developing precision antibody-based assays and vaccine candidates needed to successfully manage and slow the rate of the outbreak. As a result, Covaxx is quickly expanding to meet aggressive development and production goals, and is seeking to immediately hire a Director, to lead ongoing efforts in the design and development of ELISA/EIA based kits for the diagnosis of Covid-19 related disease.
The Director of Diagnostic Product Development will have full responsibility for the product development process from initiation to product launch. This role requires both technical expertise in IVD assay development and configuration as well as exceptional project leadership skills with the ability to meet aggressive product development deliverables and milestones, through the leadership of cross-functional teams encompassing R&D, manufacturing, quality control, quality assurance, technical support, regulatory, and commercial functions.
- PhD or equivalent in immunology, microbiology, or a related discipline.
- A minimum of 10 years of experience in the design and development of antibody-based IVD products in a regulated environment.
- Experience leading regulated IVD product development under design control, including transfer, verification, and validation activities necessary for research and diagnostic product commercialization.
- Deep understanding of ELISA/EIA based technologies.
- Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO: 14971 and other relevant standards.
- Excellent technical scientific writing, communication, and organizational skills combined with the ability to manage multiple priorities.
All candidates must be willing to work on a full-time basis at Covaxx’s headquarters in Hauppauge, New York.
By submitting your resume through this posting, you are authorizing the review of your resume, including name and contact information, solely by Covaxx, Inc. and/or its authorized representative as a prospective candidate for the position described. Your submission will be deemed strictly confidential, and in no circumstance will your personal information be provided to any other individual or company without your written consent.
For further information go to: covid19searchpartners.com.
Long Island, Nassau County, Brooklyn, Queens, Brookhaven, Medford, Smithtown
Location/Region: Hauppauge, NY