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Experience developing and applying biological characterization methods (e.g. cell-based assays, BLI or other protein binding kinetic assays, ELISA, and homogeneous assay formats such as AlphaLISA.
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Perform cell-based assay to evaluate gene editing efficiency of candidate’s formulations, and maintain mammalian cell culture for research projects, and downstream cellular DNA extraction and NGS or sanger sequencing assays for data analysis.
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Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products.
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This role reports to Bothell Site Quality Head. Duties/Responsibilities Extensive management experience in a cGMP testing laboratory environment, with knowledge of regulatory and compendial guidelines as related to cell-based assay requirements, aseptic processing, and biosafety of cell therapy products.
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Establish and maintain analytical assay performance trending program and reference standard trending program. Establish and maintain analytical assay performance trending program and reference standard trending program.
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The candidate must have strong background in small molecule chemistry and analytical chemistry, as well as in managing quality investigations, assay study design and technical report writing. The candidate must have strong background in small molecule chemistry and analytical chemistry, as well as in managing quality investigations, assay study design and technical report writing.
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Assist in the implementation of new assay methodologies and the associated instrumentation. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP.
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Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports. Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports.
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The Senior Quality Control Analyst will be responsible for the organization of the laboratory, assigning assay to analysts, creating sampling schedules, and ensuring proper steps are followed from a batch's beginning to release phase.
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Represent the assay development capability in cross-functional program teams and provide expertise and insights to drive project forward. You will spearhead cell-based assay development and execution to deeply understand our pre-IND candidates.
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Build GMP quality systems and the compliance infrastructure for the Quality Control labs. Experience with flow cytometry, bioassays, molecular biological assays and microbiological assays. 12+ years' experience in the pharmaceutical or biotechnology industry in a Quality Control, Analytical Development, Quality or Compliance function managing department teams.
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As co-lead of the Study Core Team the CS will lead via a matrix organization RWE Platform RWE Scientists/Clinical Epidemiology, QCL, Biostats, Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF), Experience in laboratory testing such as: SEC UHPLC, Potency and Residual Protein (ELISA), Osmolality, Solo VPE, Capillary Electrophoresis (SDS/rCE-SDS), Assay (icIEF.
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Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner. The primary focus of the Quality Control Associate I role will be to support raw material testing and release within a cGMP environment.
$30 - $35 an hourExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Good working knowledge of analytical and bioanalytical assays. Cell and Gene Therapy product experience. Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution.
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assay job in Bothell, WA
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