Qorvo Sr. Assay Developer in Plymouth, Minnesota
Qorvo is an E-Verify employer.
Site: MN - PlymouthBusiness Title: Sr. Assay DeveloperShift: Normal Day
The person filling this role will be responsible for assay development for new business initiative within a non-medical company focused on bringing a novel Point of Care solution to the In Vitro Diagnostic (IVD) testing market with a TAM of over $1B. The Sr. Assay Developer position has significant impact on the company's ability to launch a point of use diagnostic system. This role will lead the effort for the pre-launch development, regulatory submission and post launch support of Qorvo’s point of care diagnostic system. The incumbent leads problem solving activities involving assay development, reagent manufacturing and issues with product performance. The Sr. Assay Developer has the technical capacity to develop experimental hypotheses, design and perform experiments, analyze data sets, and write protocols and reports. Activities in this role include presenting technical aspects of assignments, leading team efforts, working effectively with all levels within the department and being responsive to project priorities.
Responsible for the development of protein and molecular IVD assays on Qorvo’s POU system
Develop and optimize the assays on Qorvo’s biosensor platform through assay design including antigen capture method, blocking method, reagent selection, predicate method selection, calibrator/calibration development, and assay conditions to achieve high level of assay performance
Participates on multifunctional teams related to launching Qorvo’s POU system
Assist in process development, product optimization, including manufacturing and QC procedures
Conducts verification and validating studies leading to regulatory submissions
Resolves manufacturing discrepancies using knowledge of the technical product details, design control and basic manufacturing and regulatory issues
Possesses strong computer skills. Can manage and analyze statistical data sets
Conducts technology transfer to manufacturing
Keeps current on standards and trends in IVD market
Bachelor's degree in Biochemistry, Biology, Chemical Engineering, or Chemistry required; Master's preferred
6 to 10 years of Commercial Assay Development experience – or equivalent
Proven skills and experience in experimental design, trouble-shooting, preparing SOPs, validation and bioanalytical reports
Assay development (protein) experience on high throughput or POC analyzers
Extensive hands-on experience in assay development and validation, such as ELISA plates or high throughput immunoassay systems
Good understanding of FDA guidance on methods for validating human IVD
Experience with the following analytical systems preferred:
SPR, QCM, or equivalent
Nucleic acid amplification and detection
Advanced data reporting and communication skills
Candidate MUST be capable of obtaining a DoD security clearance.
MAKE A DIFFERENCE AT QORVO
We are Qorvo. We do more than create innovative RF solutions for the mobile, defense and infrastructure markets – we are a place to innovate and shape the future of wireless communications. It starts with our employees. As a unified global team, we bring a commitment to excellence, growth and a passion for creating what's next. Explore the possibilities with us.
We are an Equal Employment Opportunity (EEO) / Affirmative Action employer and welcome all qualified applicants. Applicants will receive fair and impartial consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, military or veteran status, physical or mental disability, genetic information, and/or any other status protected by law.
Location: MN - Plymouth
Activation Date: Monday, April 16, 2018
Expiration Date: Wednesday, April 17, 2019