Method Transfer Lead

20 hours ago

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

Location: Bothell, WA (Remote)/Hybrid)

Duration: 18 months

Pay-rate: $55-$60/hr.

Description:

We are seeking a highly skilled Method Transfer Lead to join our Development QC team. As a key member of our team, you will be responsible for ensuring that method transfer and validation comply with cGMP and regulatory expectations.

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.

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:

  • 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

Interview Process:

  • 1st Teams bridge
  • 2nd Panel Teams (Camera On)

Position Comments visible to Supplier:

  • Non-lab based position.

Open to Fully Remote (prefer Hybrid local to Bothell)

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