Fortira Inc. · 14 hours ago
Senior QC Scientist - Method Transfer Lead (MTL)
Bothell, WA
Contract
Hybrid
Senior Level, Lead/Staff
8+ years expFortira Inc. is a company specializing in quality control within the biotechnology and pharmaceutical sectors. They are seeking a Senior QC Scientist - Method Transfer Lead (MTL) who will be responsible for overseeing method transfer and validation processes while ensuring compliance with regulatory standards.
ConsultingInformation TechnologyIT InfrastructureSoftware
Hiring Manager
Bhargava Gummadi
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 transfer 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
Required
Bachelor's degree in life science 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 studies/protocols/reports
Expert knowledge of scientific principles and expertise of mAb, ADC, vaccine, gene therapy, able to design and evaluate the design of study/experiment
Good project management skills and experience managing multiple projects at the same time is essential
Possess strong data interpretation, method troubleshooting, skills and sounds scientific judgement
Good time management skills with attention to detail and desire to achieve team and individual goals
Good communication skills to lead a team and influence other leaders or cross-functional team members
Understand of 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
Post-graduate degree in a related field is a plus
Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS) are preferred but not required
Company
Fortira Inc.
At Fortira, we completely understand that each of our customer's needs are different and our solutions are just that- Tailor-made for you.
201-500 employees
H1B Sponsorship
Fortira 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 (1)
2024 (1)
2023 (2)
2022 (1)
2021 (3)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2025-04-21Acquired
Leadership Team
Veera Gupte
Talent Acquisition Partner / Recruiting lead
Recent News
2025-04-22
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