Description
Staff Scientist is a senior technical position for individuals who can provides technical and project leadership guidance to highly skilled individual contributors. The candidate will oversee the development of immunoassays for in vitro diagnostics. Responsibilities may include leading multifunctional teams made up of scientific, engineering and/or technical staff, and ensure all industry standards and related regulatory requirements are consistently met. Is prepared to invest time and effort in becoming a subject matter expert in selected disease states (e.g. blood borne viruses, reproductive/fertility disorders, tumor markers, cardiac disease, etc.)- Formulates/monitors project plans
- May assign work to others
- May be the key contact for outside application/technology providers
- Adheres to research and development scientific standards
- Recommends process improvements
- Leads training and guidance of junior scientists
- Adheres to policies and procedures
- Exercises independent judgment
- Develops advanced concepts, and designs for complex issues
Qualifications
- Bachelor's degree in field with 9+years experience, OR Master's degree in field with 7+years experience, OR Doctoral degree in field with 4+years exp.
- Demonstrated success in development and commercialization of an IVD device is necessary.
- Experience as a project or program leader is desired
- Experience in developing and commercializing IVD products for any of the following areas would be an advantage: infectious diseases, endocrinology, cardiology, oncology, or fertility/reproductive biology.
- Experience working in a quality and regulatory environment - familiarity with external regulatory bodies (e.g. FDA, ISO, CAP, etc.) desired.
- Experience with administration of clinical trials would be helpful.
To find out more about Real please visit www.realstaffing.com