Qorvo Sr. Assay Developer in Plymouth, Minnesota

Description:

Qorvo is an E-Verify employer.

Site: MN - PlymouthBusiness Title: Sr. Assay DeveloperShift: Normal Day

SUMMARY:

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.

RESPONSIBILITIES:

  • 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

QUALIFICATIONS:

  • 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:

  • HPLC

  • SPR, QCM, or equivalent

  • Protein Modification

  • 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

Apply Here