Scientist II- MPD
Company: Adaptive Biotechnologies
Posted on: June 12, 2021
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
You belong here- come discover your story at Adaptive.
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.
- 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
- 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
- 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
- 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.
- 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
- Solid understanding of multiplex PCR and NGS technologies,
generic sequencing data analysis and statistical methods.
- Proven experience in LDT/CLIA, FDA and other Regulatory
- 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
- Hands-on, self-directed, organized, and conscientious.
- Must work independently and be able to prioritize and manage
multiple projects with rigorous timelines.
- Prior experience with NGS diagnostic product
- Prior experience with IVD/IDE 510K or De Novo FDA
- Prior experience with JMP, R, or other statistical analysis
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
Keywords: Adaptive Biotechnologies, Seattle , Scientist II- MPD, Other , Seattle, Washington
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