Method Transfer Lead Scientist Job North Bothell Area area,Washington USA,Pharmaceutical

This role will serve as the coordinator and primary document author for all validation activities, including method validation, method transfer documentation, and report writing.
The top required skill is hands‑on Quality Control laboratory experience.
The second key requirement is a strong background in analytical separation methods.
The third requirement is experience with method validation and method transfer.
On a typical day, the individual will draft validation documents and meet with stakeholders to align content, expectations, and approvals. Since the documents issued will serve as official validation protocols, alignment on scope and content is critical.
Report authoring will require significant input from cross‑functional teams, so excellent communication and coordination skills are essential.
Experience in bio pharmaceutical chemistry, particularly with biologics such as mAbs or ADCs, would be highly beneficial.

Job Description

Method Transfer Lead (MTL), Scientist, is a QC expert within the QCSV group. This individual contributor has a good understanding of analytical method transfer and/or validation to ensure that method transfer and/or validation comply with cGMP and regulatory expectations.
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.

Education And Experience

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.

Technical Skills

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

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