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Monitor assay development, assay validation and sample analysis processes, ensure timely delivery of quality results in compliance with regulatory guidance. Act as the project manager to support the externalization and operationalization of clinical biomarkers and bioanalytical activities for pre-clinical and clinical drug development.
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The Analytical Research and Development Chemist will work with an assigned project team of chemists in the laboratory to analyze and develop HPLC and GC methods for assay, impurity and dissolution testing of pharmaceutical finished dosage forms.
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The Senior/Principal Scientist will be part of the CMC ARD team responsible for drug product related CMC strategy development for clinical stage biosimilar and conjugate biologics programs. Experience with any or all of the following is considered advantageous: potency assay, plate-based assays, spectroscopy (UV-Vis, FT-IR, CD, and fluorescence.
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Expert knowledge and hands-on experience with in vitro assay development required. Insmed is seeking an innovative and highly motivated senior scientist to support development, production, and characterization of novel AAV gene therapies at the New Jersey Research Development Labs. Responsibilities may include AAV production and purification, AAV potency testing, AAV titration, and AAV transgene construct design.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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The individual will work close with preclinical, CMC and clinical development team to develop mechanism of action hypotheses and identify key characteristics of cell therapy products. Establish translational biomarker strategy in alignment with clinical development objectives; Lead translational safety investigation, develop MOA hypothesis and identify key characteristics relevant to efficacy and treatment failure.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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The Analytical Chemist will work with an assigned project team of chemists in the laboratory to analyze and develop HPLC and GC methods for assay, impurity and dissolution testing of pharmaceutical finished dosage forms.
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In vivo study design and assay development. Provide strategic direction for in vivo CAR-T cell therapy development. You will collaborate with cross-functional teams, including research, development, and manufacturing, to drive the successful translation of preclinical findings into clinical applications.
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This individual will focus on technology transfers from Analytical Development (AD) to support ongoing GMP QC operations, as well as driving and developing assay automation and scalability solutions to improve reliability, safety, cost-effectiveness, and compliance.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Responsible for method development and execution of analytical techniques such as Karl Fischer, Dissolution, and Assay / Impurities to facilitate the support of drug product development.
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The Analytical Chemist will work with an assigned project team of chemists in the laboratory to analyze and develop HPLC and GC methods for assay, impurity, dissolution, residual solvents testing, Particle size distribution of active pharmaceutical ingredients, excipients and finished dosage forms.
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Hands on experience with cell culture techniques, including cell isolation, culture maintenance, and assay development. Assist in the development and validation of new laboratory techniques and protocols for medical device testing.
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Perform mechanical, physical or chemical assay testing as directed by supervis. This position will support research and development of new tissue forms by processing research tissue, conducting experiments and testing biomechanical and biochemical properties of allograft tissue.
Full-timeExpandApply NowActive JobUpdated 23 days ago
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