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A clinical-stage biotechnology company is seeking an experienced professional to manage assay development and validation, focusing on bioanalytical assays for immunological diseases and cancer treatments.
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A minimum of 3-5 years in Analytical Development and/or Quality Control preferably in a clinical stage biopharmaceutical company. The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates.
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Is seeking a talented and motivated individual with expertise in enzymology and biochemical & biophysical assay development to join the Bioassay & Profiling group to support small molecule drug discovery programs within the Discovery Technologies department in our South San Francisco research site.
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This role works closely with key stakeholders including CMC, Supply Chain, Development, R&D, Clinical, Regulatory Affairs and Project Management to define the analytical capabilities required to effectively manage Dyne's complex clinical supply chain and support eventual launch and commercialization efforts.
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The Sr./Scientist, Quality Control Bioanalytical is responsible for the development, optimization, qualification and validation of analytical procedures or transfer of client’s analytical procedures used in Quality Control Bioanalytical operation for product release, stability, and process characterization.
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The Associate Scientist participates in cellular assay development, validation, and execution including sample analysis in a timely manner. Precision for Medicine is the first global, precision-medicine, biomarker-driven contract and clinical research organization, with expertise in today’s most advanced techniques for deeply interrogating samples to better understand patient biology.
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The successful candidate will have a depth of experience performing in vitro experiments with primary human immune cells and assay development. The position will play a key role in development and evaluation of our cell targeted lipid nanoparticle (ctLNP) delivery platform by devising and executing a strategic plan aimed at evaluating ctLNPs interacting with immune cells.
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Responsible for the design and execution of phase-appropriate clinical and preclinical analytical strategies including immunoassay, quantitation of lipid and therapeutic proteins, lipid characterization, metabolite identification and PK/PD assay method development.
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Collaborate with cross-functional teams, including bioinformatics and clinical teams, to ensure successful assay development and implementation. The successful candidate will play a key role in the development and optimization of NGS-based assays for various applications, including clinical diagnostics, research, and drug development.
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Experience in method development of bioassay, immunoassay, or molecular biology assay. Hands-on experience in assay development and sample testing of RNA and LNP products. Be the interface between Analytical Development and QC GMP to support assay transfer, qualification, and validation.
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Follows the instructions of the Authorized User (AU) physician and authorized nuclear pharmacist for the preparation of radiopharmaceuticals and quality control testing. Performs clinical and research diagnostic molecular imaging testing to include general, cardiac, and PET studies along with the computer interactions associated with these studies.
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As a Clinical Research Coordinator I, you will work independently providing study coordination including screening of research participants for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
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The In-House CRA will be responsible for supporting the clinical operations team in planning, executing, and managing medical device clinical trials while ensuring compliance with regulatory standards and maintaining high-quality documentation within the Trial Master File (TMF) system as well as assisting in the review of study data entered into the electronic data capture (EDC) system.
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The Senior Manager of Quality Systems will be responsible for partnering with global Quality stakeholders for development, implementation, and continuous improvement of Quality Management Systems (paper and electronic) which include but are not limited to Document Control, Deviations, CAPA, Change Control, and Quality Management Review (QMR) to serve the needs of the contract manufacturing organization.
$160,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Primary interface and manager of external vendors/CROs supporting preclinical and clinical bioanalytical assay development and management. Work closely with cross-functional teams: Research and Development for development of stage-appropriate assays; Clinical Operations for biosample logistics; Clinical Development for clinical data management and presentation.
$150,000 a yearFull-timeExpandApply NowActive JobUpdated Today
clinical research assay development quality control jobs Title: research associate
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