Joulé · 14 hours ago
QC Method Validation & Transfer Coordinator
Bothell, WA
Contract
Onsite
Senior Level, Lead/Staff
$45/hr - $54.80/hr
8+ years expJoulé is a leading pharmaceutical company seeking an experienced QC Method Validation & Transfer Coordinator. The role involves supporting method transfer and validation, authoring protocols and reports, and collaborating with internal and external testing sites.
Staffing & Recruiting
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
Qualification
Required
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
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
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
Candidate with analytical separation method experiences (SEC, icIEF, CE-SDS ) are preferred but not required
Benefits
Health and welfare benefits coverage options
Medical
Dental
Vision
Spending accounts
Life insurance
Voluntary plans
Participation in a 401(k) plan
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase