Net2Source (N2S) · 19 hours ago
Method Transfer Lead (MTL) Scientist
Bothell, WA
Full-time
Onsite
Senior Level, Lead/Staff
$45/hr - $49.66/hr
8+ years expNet2Source Inc. is a global leader in workforce solutions, connecting top talent with the right opportunities. The Method Transfer Lead (MTL), Scientist is a QC expert responsible for ensuring compliance with cGMP and regulatory expectations in method transfer and validation activities.
B2BDeliveryHuman ResourcesInformation Technology
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, method validation, method bridging, and other technical development reports associated with analytical 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 representatives
Review method transfer and/or method validation assays, perform data verification, non-routine data mining, and in-depth data analysis
Represent QC in intra-department projects/initiatives or cross-functional teams in support of program and company goals
Qualification
Required
Bachelor's degree in Life Sciences required
8–10 years of relevant experience in pharmaceutical or biological drug product development, analytical chemistry, and/or Quality Control within a regulated biotechnology or pharmaceutical company, with progressive levels of responsibility
Expertise in designing and evaluating method validation and transfer studies, including partial re-validation, co-validation, and cross-validation approaches
Strong technical writing skills for authoring analytical methods, validation studies, and transfer protocols/reports
Expert knowledge of scientific principles related to mAbs, ADCs, vaccines, and gene therapy, with the ability to design and evaluate experimental studies
Strong understanding of analytical and plate-based methods
Strong project management skills with experience managing multiple projects simultaneously
Strong data interpretation, method troubleshooting skills, and sound scientific judgment
Excellent time management skills with strong attention to detail and commitment to achieving team and individual goals
Strong communication skills with the ability to lead teams and influence cross-functional stakeholders
Understanding of regulatory guidance and requirements (ICH, CFR, and general regulatory guidance) related to method transfer, method validation, and regulatory submissions such as IND, IMPD, BLA, or NDA
Preferred
Post-graduate degree in a related field is a plus
Experience with analytical separation methods such as SEC, icIEF, and CE-SDS preferred but not required
Company
Net2Source (N2S)
Net2Source (N2S) is a Minority owned global workforce solutions company recognized by SIA as the largest and fastest-growing Total Talent Solutions provider with a presence in 34 countries and in-house Glo-Cal (global and local) teams to support our clients.
1001-5000 employees
H1B Sponsorship
Net2Source (N2S) 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 (3)
2024 (7)
2022 (8)
2021 (10)
2020 (25)
Funding
Current Stage
Late StageLeadership Team
Ashish Garg
Founder & CEO
Company data provided by crunchbase