RCI-PFE-Method Transfer Lead Scientist: Bothell,WA - Hybrid

• Will be a coordinator and the document writer for all of the validation, method validation, the transfer document and the report authoring.
• Top skill it would be quality control lab experience first thing. Second thing is the analytical separation method background. Third thing is method validation to transfer experience.
• So basically a typical day where we'll be drafting a document and have the meeting with the stakeholder just to align what need to be written in the document and.
• Align about what's the content they agree or because the document the person going to issue will be the actual validation protocol.
• The report need a lot of inputs from other people, so this person must be have a very good communications.
• Biofarm chemistry with the experience with all of the biologics, basically like map or ADC experience will be very helpful.

• Summarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. (It may be helpful to complete this section after you have finished the other sections of the document.
• Method Transfer Lead (MTL), Scientist, is a QC expert within the QCSV 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.

In order of importance, list the primary responsibilities critical to the performance of the position. Please include actual tasks and/or essential responsibilities that highlight accountability and level of judgment required.

• 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.

Provide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.

• PGS (Client Global Supply)
• Analytical R&D

Indicate the formal education, certification or license(s) required and/or preferred. Include the minimum number of years of relevant experience required for the position (where legally permissible).

• Bachelor’s degree in life science (Post-graduate degree in a related field is a plus) in analytical chemistry, biology, biochemistry, pharmaceutical science or any related technical discipline
• 8-10 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

Indicate the technical skills required and/or preferred, as applicable.

• 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 methods. Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS ) 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.