LanceSoft, Inc. · 2 hours ago
Method Transfer Lead / Quality Control
Bothell, WA
Contract
Hybrid
Senior Level, Lead/Staff
8+ years expLanceSoft, Inc. is seeking a Method Transfer Lead / Quality Control who will act as a QC subject matter expert responsible for leading analytical method transfer and validation activities. This role involves providing technical leadership, collaborating with global teams, and ensuring compliance with cGMP and regulatory requirements.
Information Technology
Hiring Manager
Atul M.
Responsibilities
Serve as Method Transfer Lead supporting project leads for method transfer and/or validation activities for assigned programs, both internally and externally
Author, review, and approve protocols and reports for method transfer, method validation, method bridging, and related technical development documentation
Plan, coordinate, and track method transfer and validation deliverables to ensure timely and compliant execution
Collaborate with internal global QC testing sites/laboratories, external testing partners, project leads, and cross-functional stakeholders
Review method transfers and validation data, perform data verification, conduct non-routine data mining, and perform in-depth data analysis
Provide technical expertise in assay evaluation, troubleshooting, and scientific decision-making
Represent Quality Control in intra-departmental initiatives and cross-functional teams to support program and organizational goals
Qualification
Required
Bachelor's degree in Life Sciences required; post-graduate degree preferred
Fields may include Analytical Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related discipline
Minimum of 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 environment
Demonstrated progressive responsibility in method transfer, validation, and cross-functional project support
Expertise in designing, executing, and evaluating method transfer and validation studies, including partial re-validation, co-validation, and cross-validation approaches
Strong technical writing skills for authoring analytical methods, validation protocols, transfer protocols, and final reports
Expert understanding of scientific principles related to monoclonal antibodies, cell and gene therapy, vaccines, and biologics
Strong background in analytical and plate-based methods; experience with analytical separation techniques (e.g., SEC, icIEF, CE-SDS) preferred
Proven project management skills with the ability to manage multiple priorities and projects simultaneously
Strong data interpretation, method troubleshooting, and scientific judgment capabilities
Excellent time management skills with high attention to detail and commitment to quality
Strong communication and collaboration skills, with the ability to influence cross-functional teams and stakeholders
Solid understanding of regulatory guidance and requirements (e.g., ICH, CFR) related to method transfer, method validation, and regulatory submissions (IND, IMPD, BLA, NDA)
Preferred
Post-graduate degree preferred
Experience with analytical separation techniques (e.g., SEC, icIEF, CE-SDS) preferred
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
H1B Sponsorship
LanceSoft, Inc. 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 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)
Funding
Current Stage
Late StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase