Quality Control Chemist

Title: - Quality Control Chemist

Location: 22515 29th Dr SE, Bothell, WA, USA, 98021

Duration: 12 months (with possible extensions)

Role: Quality Control Chemist

Chat Notes from HM

not a lab-based role

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 needs a lot of inputs from other people, so this person must be having a very good communication.

Biofarm chemistry with the experience with all of the biologics, basically like map or ADC experience will be very helpful.

POSITION SUMMARY
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.

POSITION RESPONSIBILITIES
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.

ORGANIZATIONAL RELATIONSHIPS
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.
QCSV-Portfolio
PGS (Global Supply)
Analytical R&D

EDUCATION AND EXPERIENCE
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

TECHNICAL SKILLS REQUIREMENTS
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.