USA – Quality Control Chemist – IV

SGS_JOB_3421

Business Support
 Washington
Method Transfer
Method Validation
cGMP
Analytical Chemistry
QC
Data Analysis
Technical Writing
Regulatory Compliance

Contract - 12 Months Contract

Location (mandatory): Bothell, WA, USA 98021 Small Description: The Method Transfer Lead (MTL), Scientist, is a Quality Control expert within the QCSV group responsible for ensuring analytical method transfer and/or validation activities comply with cGMP and regulatory expectations. This role serves as an individual contributor with a strong understanding of analytical method transfer, validation strategies, and regulatory requirements. The position supports internal and external method transfer activities while collaborating with global QC labs and cross-functional teams. The scientist authors and reviews technical documentation, analyzes complex data, and represents QC on project teams. The role requires strong scientific judgment, project management skills, and effective communication to support program and company goals.

Job Responsibilities:

  • Support the Project Lead for method transfer and/or validation activities internally and externally for assigned programs
  • Author and/or review protocols and reports for method transfer, method validation, method bridging, and other associated technical development reports
  • Plan, manage, and track method transfer and/or method validation deliverables
  • Collaborate with internal global QC testing sites/labs, external testing labs, project leads, and functional representatives
  • Review method transfer and validation assays, perform data verification, conduct non-routine data mining, and execute in-depth data analysis
  • Represent Quality Control in intra-departmental initiatives and cross-functional project teams in support of program and company objectives

Skills:

  • Expertise in designing and evaluating method validation and method transfer studies, including partial re-validation, co-validation, and cross-validation approaches
  • Strong technical writing skills for authoring analytical methods, validation studies, transfer protocols, and reports
  • Expert knowledge of scientific principles related to monoclonal antibodies (mAb), ADCs, vaccines, and gene therapy
  • Strong analytical mindset with experience in analytical and plate-based methods
  • Experience with analytical separation techniques such as SEC, icIEF, and CE-SDS (preferred but not required)
  • Excellent project management skills with the ability to manage multiple projects simultaneously
  • Strong data interpretation, troubleshooting capabilities, and sound scientific judgment
  • Effective time management, attention to detail, and goal-oriented work ethic
  • Strong communication skills with the ability to lead teams and influence cross-functional stakeholders
  • Solid understanding of regulatory guidance and requirements (ICH, CFR, and general regulatory guidance) related to method transfer, validation, and regulatory submissions such as IND, IMPD, BLA, and NDA

Education/Experience:

  • Bachelor’s degree in Life Sciences (Analytical Chemistry, Biology, Biochemistry, Pharmaceutical Science, or related discipline); post-graduate degree preferred
  • 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

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