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Senior Scientist

2 months ago

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{"title": "Job Description", "content": "Job Title: Scientist, Method Transfer Lead

Location: Bothell, WA

Duration: 18 months

Payrate: $50- $60/hr on w2 without benefits

Job Summary:

We are seeking a highly skilled Scientist, 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/or 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.
  • 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, Client, vaccine, gene therapy, able to design and evaluate the design of study/experiment.
  • 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.
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).

", "lang_code": "en"}