Scientist, Method Transfer Lead

Job Description: POSITION SUMMARY:

• 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.
  
  

POSITION 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.
  
  

ORGANIZATIONAL RELATIONSHIPS:

• QC TT team
• QCSV-Portfolio
• PGS (*** Global Supply)
• Analytical R&D
  
  

EDUCATION AND EXPERIENCE:

• 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, Client, 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)