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Associate Director - Assay Development (NAT)

Company: Grifols Shared Services North America, Inc.
Location: San Diego
Posted on: September 16, 2021

Job Description:

An employer in San Diego is seeking an Associate Director of Assay Development (NAT) to join their R&D division! This individual will be responsible for leading a group of scientists working on complex research and development projects which primarily consist of test kits that test donated blood/plasma for infectious diseases prior to transfusion. This position requires experience with multiple product development projects and demonstrated success in leading the development of more than one diagnostic or blood screening nucleic acid test (NAT) from concept/feasibility to product launch. The AD Product Development position requires a strong working knowledge of regulations affecting blood screening and/or diagnostic products as well as experience in writing sections of BLA or PMA submissions. There is flexibility for this individual to work on a remote/in person hybrid model.

Experience working in a regulated environment OR with regulated products

Experience developing products that have been commercialized
PhD in Biology, Chemistry, or similar field

5+ years of relevant industry experience

Assay development experience as it pertains to new product design

PCR experience

NAT (Nuclear Acid Testing) experience

People management (must have had direct reports in past position)

Understanding of FDA/EU regulations

Keywords: Grifols Shared Services North America, Inc., San Diego , Associate Director - Assay Development (NAT), Other , San Diego, California

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