Scientist, Method Transfer Lead

1 day ago

Bothell, United States Synectics Inc Full time
Job DescriptionJob Description

Job Description:

  • Method Transfer Lead (MTL), Scientist, is a QC expert within the Development QC group.

  • This individual contributor has 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 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.

Qualifications:

  • 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

  • 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.

  • Method Transfer Validation in QC

  • Protocols and Reporting

  • Good understanding of analytical and biochemical methodology

  • Binding and Cell based assays

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