Senior Scientist in R&D/Transfer

Company: Qorvo, Inc.
Location: Plymouth
Posted on: February 24, 2021

Job Description:

Job Type: Full-Time Location: MN - Plymouth, US Requisition ID: 843 Qorvo Biotechnologies We are currently seeking a Senior Scientist in R&D/Transfer. This position has significant impact on the company's ability to launch a point of use diagnostic system. The Senior Scientist will lead the efforts for the transfer of designs from R&D to production, regulatory submission and post launch support of Qorvo Biotechnologies point of care diagnostic system. The incumbent leads problem solving activities involving scale-up, reagent manufacturing, quality and control system development and issues with product performance. The Senior Scientist has the technical capacity to troubleshoot complex problems, work with multifunctional teams, analyze data sets, write protocols/documents, and create 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 supporting scale-up verification and validation activities of diagnostic assays on Qorvo's PON system
• Leads design transfer from R&D to Manufacturing
• Participates on multifunctional teams related to launching Qorvo's PON system.
• Assist in product optimization, manufacturing scale-up support, documentation, and establishment of product quality systems
• Conducts and/or supports 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
• Keeps current on standards and trends in IVD market QUALIFICATIONS:
  • Bachelor's Degree in Biochemistry, Biology, Chemical Engineering, Chemistry or equivalent, Master's degree preferred
  • 5-8 years of experience in Commercial Assay Development, Quality Systems, Process Validation, and Manufacturing Quality.
  • Proven track record of troubleshooting, preparing SOPs, product validation, bioanalytical reports, documentation
  • Experience in design transfer from R&D to Manufacturing, Verification and Validation studies for regulatory submission of IVD products in human and/or veterinary markets
  • Good understanding of FDA guidance on methods for validating human IVD
  • Experience with the following preferred:
    • PON assay development
    • Advanced data reporting and communication skills
    • Design Control and Risk Management
    • Quality System Regulation 21 CFR 820, Quality Management System ISO 13485:2016 and ISO 9001:2015
    • Audit support
    • Preferred candidate is a US citizen or a permanent resident able to obtain 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.

Keywords: Qorvo, Inc., Plymouth , Senior Scientist in R&D/Transfer, Other , Plymouth, Massachusetts