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Scientific Method Transfer Specialist

1 month ago

Bothell, Washington, United States Joulé Full time
Job Title:
Scientist, Method Transfer Lead

As a Scientist, Method Transfer Lead, you will play a key role in supporting the Project Lead for method transfer and/or validation internally and externally for assigned programs. Your expertise in designing and evaluating method validation and transfer studies will be crucial in ensuring the accuracy and reliability of our analytical methods.

Responsibilities
  • Support Project Lead for method transfer and/or validation internally and externally for assigned programs.
  • 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.
Requirements
  • Bachelor's degree in life science (Post-graduate degree in a related field is a plus) in biology, biochemistry or any related technical discipline.
  • 8 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 Requirements
  • 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.
  • Have good mindset and technical skills of analytical methods and plate-based method.
  • Candidate with binding ELISA, cytotoxicity, resProA, res DNA and host cell protein method experiences are preferred but not required.
  • 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.
Physical Position Requirements
  • Non-lab based position.
Hard Skills
  • Method Transfer Validation in QC.
  • Protocols and Reporting.
  • Good understanding of analytical and biochemical methodology.
Preferred Skills
  • Binding and Cell based assays.
  • More than 8yrs experience.

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.