Principal Scientist

Company: Yoh
Location: Seattle
Posted on: January 15, 2022

Job Description:

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
Industry: Biotechnology
Location : Seattle, WA
Type : Full-time regular direct hire W2 employment
Responsibilities
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 material
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 platforms
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 colleagues.
Requirements
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 required.
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 required.
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 simultaneously.
Start-up experience desired
Work is performed in BSL-2 labs, following all guidelines and protective measures.
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.

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Keywords: Yoh, Seattle , Principal Scientist, Other , Seattle, Washington