Arlington Scientific, Inc. seeks a Director of Research & Development in Springville
Direct the development of advanced diagnostic microbiological serological products of the company;
Responsible for research and product development, experimental design, planning, formulation, characterization, specification, processing, design verification, pilot scale production, development of protocols, test procedures, technology transfer between research and manufacturing, training of personnel in scale-up production of IVD products and infectious disease kits, specifically for Syphilis diagnosis; Responsible for regulatory affairs activities with federal agencies such as the FDA, CDC, EPA;
Maintain activities for Quality systems of ISO 9001:2008 and ISO 13485:2003, clause # 7.3;
Prepare strategies for product development, planning and reviews, including design input and output relating to product documentation, validation and risk managements;
Responsible for intellectual property (IP) generation, creation and maintenance of IP licensing; and Supervision of 1 (One) R&D Scientist. Education/ Experience: Ph.D. degree in Microbiology, Biochemistry or related, or the foreign academic equivalent, plus 10 (ten) years of in-vitro diagnostic (IVD) industrial full-time work experience in Research and Development to include 5 years of experience in a senior managerial role.
Special Requirements: Proven ability to lead research and development team of the company;
Experience developing commercial IVD kits for infectious diseases, including Syphilis;
Must have peer reviewed publications in respected scientific journals in microbiology, biochemistry or related fields;
Regulatory affairs experience dealing with reputable Government agencies; Experience in IP licensing in IVD; and Experience in Syphilis diagnosis.
Mail resumes to: Arlington Scientifi 1840 N. Technology Drive, Springville, UT 84663, ATTN: Sandee Loader. EOE.