Analytic Dev/QC Associate IV

  • Anywhere

Company :
Fred Hutchinson Cancer Research Center

Location :
Seattle, Washington

Expiry Date :
Sun, 25 Apr 2021 23:59:59 GMT

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Description :
Job Details Full-timeEstimated: $67,000 – $93,000 a year5 hours ago Qualifications – Flow cytometry – Presentation skills – CGMP – Quality systems – Cell culture – Bachelor’s degree Full Job Description Overview: Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here. At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired our commitment to diversity, antiracism, and inclusion. This position is responsible for Quality Control (QC) cGMP testing activities in support of Human Gene Therapy Phase I/II clinical research studies. This position will primarily focus on performing transfer, qualification, and validation of analytical test methods using FDA and ICH guidelines. In ition, the position will perform routine cell-based characterization and potency assays, as well as microbial assays utilizing flow cytometry, ELISA, microscopy, and qPCR techniques. Cross-training on multiple assays will be required for this position as well as in laboratory quality systems. Responsibilities: Lead and participate in analytical method transfer/qualification/validation activities Perform cGMP in-process, lot release and stability testing of raw materials and human gene therapy products Review assays performed by peers Perform deviation and out of specification (OOS) investigations Maintain laboratory cell lines Write SOPs and test methods Perform general laboratory activities in accordance to SOPs and laboraotry quality systems Qualifications: Bachelor’s degree in a life sciences field Minimum of 6 years of related experience Knowledge of regulatory guidance documents/information for Analytical Procedures and Method Validation Knowledge of cGMP requirements for Phase I/II clinical trials Familiarity with Chemistry. Manufacturing, and Controls (CMC) information for Investigational New Drug Applications Experience with microtiter cell-based assays Familiarity with flow cytometry, ELISA, qPCR and HPLC techniques Knowledge of aseptic and cell culture techniques Good written and oral communication. Good presentation skills Detail oriented, organized, proactive and self-motivated Possess strong communication and teamwork skills Ability to analyze data, assess/evaluate trends and make recommendations for improvement Experience with typical Quality Systems (ex. Document Control, Deviations, CAPA, Change Control, etc.) A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists. Our Commitment to Diversity: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at or by calling . Apply Now