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Scientist II- MPD

Company: Adaptive Biotechnologies
Location: Seattle
Posted on: June 12, 2021

Job Description:

We are powering the age of immune medicine- you can too. At Adaptive, our goal is to meaningfully improve people's lives by learning from the wisdom of the adaptive immune system.

As an Adapter, you will be surrounded by driven colleagues who think boldly to pursue ground-breaking innovation. You will experience meaningful challenge in your work and be fueled by motivating energy knowing you make a difference in people's lives.

You belong here- come discover your story at Adaptive.

Position Overview

Adaptive is seeking a motivated and high-performing Scientist II candidate to lead technical development activities for clinical NGS products in the New Indications team of the Molecular Product Development (MPD) group. This role spans activities from product concept through product development, validation, approval, and commercial launch for new product applications on Adaptive's clonoSEQ and T-Detect platform technologies. The successful candidate will oversee study execution within MPD as well as participate as a subject matter expert in core teams and with other cross-functional stakeholders and working groups.

Responsibilities

  • Act as a MPD technical lead for development and validation activities for new Laboratory Developed Tests (LDTs) and single-site IVD product applications for the existing clonoSEQ (B-cell) and T-Detect (T-cell) platform technologies within a matrixed core-team environment.
  • Initiate and manage study design planning of IVD-level verification and validation studies, providing innovative strategies to adhere to appropriate regulatory guidance, specifically CLSI. Generate and abide by study timelines, product development plans, design trace matrices and other Design Control related requirements.
  • Oversee execution of FDA-level analytical validations and method development and validations, including the authoring of technical documents (protocols/reports), contributing to document review, and compiling/referencing supplementary documents for FDA level submissions.
  • Participate in cross-functional core teams with the PMO, RA/QA, MPD teams, Biostats, Clinical Ops., Laboratory Ops., Research and Commercial groups to ensure project/product success. Maintain a solutions-oriented focus with diverse functional stakeholders.
  • Oversee project timelines and resourcing to maximize product development teams' performance in a highly cross-functional environment.
  • Become a subject matter expert on Adaptive's products. Provide scientific guidance and technical expertise.
  • Assist project technical leaders with cross-functional alignment and conflict resolution by proactively considering alternative options and cost/risk analyses.
  • Ensure compliance with internal procedures, design control, CLSI guidelines and other applicable regulations.

Requirements

  • Ph.D. in Molecular Biology, Biochemistry or related field and a minimum of 5 years' experience with 3 years of experience in a diagnostic or medical device company strongly preferred. Or MS degree with 13+ years' experience in highly relevant industry setting.
  • Solid understanding of multiplex PCR and NGS technologies, generic sequencing data analysis and statistical methods.
  • Proven experience in LDT/CLIA, FDA and other Regulatory compliance requirements.
  • Exceptional scientific technical writing, communication, and organizational skills, with a significant attention to detail. Must be able to communicate effectively, both written and verbally with technical and non-technical audiences.
  • Demonstrated ability to think strategically when planning and managing responsibilities.
  • Hands-on, self-directed, organized, and conscientious.
  • Must work independently and be able to prioritize and manage multiple projects with rigorous timelines.

Preferred

  • Prior experience with NGS diagnostic product commercialization.
  • Prior experience with IVD/IDE 510K or De Novo FDA submissions.
  • Prior experience with JMP, R, or other statistical analysis software.

Adaptive Biotechnologies is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Opportunity Employer/Veterans/Disabled

NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.

Keywords: Adaptive Biotechnologies, Seattle , Scientist II- MPD, Other , Seattle, Washington

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