Posted on: January 15, 2022
Yoh is seeking a Principal Scientist - to support our
Biotechnology client in Seattle, WA for full-time direct hire role.
This role will support development of new IVD products.
Hours : Mon-Fri day hours, flexible
Location : Seattle, WA
Type : Full-time regular direct hire W2 employment
Participate in efforts to support the development of IVD products
under design control in conformance with ISO13485(2016) or FDA 21
CFR Part 820 requirements.
Partner with biostatistics
Develop methods for characterizing the composition, functional
performance, and stability of reagents
Develop new PCR-based assays for reagent qualification for incoming
Design QC method validation and stability study experimental
procedures, author and execute the protocols, review and analyze
data, interpret results and write the study reports.
Provide mentorship and leadership
Provide training for Operation QC personnel
Provide expertise in selecting, designing, optimizing, qualifying,
validating, and implementing molecular assays and laboratory
Create required documents including reagent quality control testing
procedures, incoming material specifications, protocols and reports
for verification and validation studies and studies required to
transfer reagent products into production
Ensure consistent compliance with applicable regulations and
quality-related best practices in development, validation, use, and
documentation of assay development, analytical and functional
quality control test methods for reagent lot qualification,
stability studies, and related activities.
Cultivate positive and productive working relationships with
Advanced degree (PhD) in molecular biology, biochemistry,
chemistry, engineering or an associated relevant field
8+ years of relevant industrial experience is required
Strong background in biochemistry and molecular biology methods
with experience in analytical method development, QC for nucleic
acid isolation, purification and quantitation, qPCR, and next
generation sequencing assays.
Proven supervisory experience is desirable.
Expert knowledge of PCR platforms.
Extended knowledge of liquid handling platforms with extensive
experience designing and implementing molecular assay. Knowledge in
assay validation, design purpose driven experiment considering
parameters including but not limited to disease type, patient
population, tissue types, sample matrix, sampling method and
storage condition, extraction method, sensitivity and dynamic range
of the assays and analytical platforms, purpose of analyte
measurement (qualitative, or quantitative) etc.
LIMS experience a plus, but not required.
A track record of success in method development and product
transfer projects for new IVD molecular diagnostic products under
ISO 13485 and/or FDA Quality System Regulations (QSR) is
Experience with IVD product development activities for PMA
submission is a plus.
Highly motivated, detail-oriented individual with consistent record
in solving technical problems effectively and efficiently.
Superb communication, collaboration, and leadership skills are
Ability to prioritize and adapt to changing priorities while
maintaining a high standard on quality.
Ability to work in a fast paced, multidisciplinary and dynamic
environment and capable of handling multiple activities
Start-up experience desired
Work is performed in BSL-2 labs, following all guidelines and
Where permitted by applicable law, applicant must have received, or
be willing to receive, a COVID-19 vaccine by date of hire to be
considered for employment.
Keywords: Yoh, Seattle , Principal Scientist, Other , Seattle, Washington
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