Method Transfer Lead Scientist jobs in United States
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Integrated Resources, Inc ( IRI ) · 17 hours ago

Method Transfer Lead Scientist

positionBothell, WA
timeContract
remoteOnsite
senioritySenior Level, Lead/Staff
money$52/hr - $53/hr
date8+ years exp

Integrated Resources, Inc (IRI) is seeking a Method Transfer Lead Scientist who is a QC expert within the QCSV group. This role involves ensuring compliance with cGMP and regulatory expectations for analytical method transfer and validation, while collaborating with global QC testing sites and project leads.

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H1B Sponsor Likelynote
Hiring Manager
Shivi Singh
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Responsibilities

Support Project Lead for method transfer and/or validation internally and externally for assigned program(s)
Author or review protocols and reports for method transfer and/or method validation or method bridging, and other technical development reports associated with methods
Plan and track method transfer and/or method validation deliverables
Collaborate and interact with internal global QC testing sites/labs and external testing sites/labs, project leads and functional reps
Review method transfers and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis
Represent QC in intra-department project/initiative or cross-functional teams in support of program and company goals

Qualification

Method validation expertiseAnalytical chemistryRegulatory compliance knowledgeTechnical writingProject managementData analysisCollaboration skillsCommunication skills

Required

Bachelor's degree in life science (Post-graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any related technical discipline
8-10 years relevant experience in pharmaceutical/biological drug product development, analytical chemistry and/or QC in a regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required
Expertise in designing and evaluating method validation and transfer studies including approaches such as partial re-validation, co-validation, and cross-validation
Technical writing skills for authoring methods, validation, and transfer of studies/protocols/reports
Expert knowledge of scientific principles and expertise of mAb, Client, vaccine, gene therapy, able to design and evaluate the design of study/experiment
Have good mindset and technical skills in analytical methods and plate-based methods
Good project management skills and experience managing multiple projects at the same time is essential
Understand regulatory guidance and requirements (ICH, CFR, general guidance) pertaining to method transfer and method validation, regulatory submission such as IND, IMPD, BLA or NDA, etc

Preferred

Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS ) are preferred but not required

Company

Integrated Resources, Inc ( IRI )

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Integrated Resources Inc.
dateFounded in 1996
location
Edison, New Jersey, USA
people-size501-1000 employees
web-link
http://irionline.com

H1B Sponsorship

Integrated Resources, Inc ( IRI ) has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (5)
2023 (13)
2022 (9)
2021 (25)
2020 (39)

Funding

Current Stage
Late Stage

Recent News

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