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This is a customer-facing, customer-centric role and requires deep understanding of data management and flow in one (or more) scientific domains including process development, analytical chemistry, CMC, MAbs discovery, lab automation, protein production, in vitro screening, or assay development.
Full-timeRemoteExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Completion of assay development projects, demonstrate excellent documentation skills and will be. Typically requires 1 - 2 years experience in an assay development environment. The Analytical Development Research Associate performs a variety of well-defined support functions and.
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Key Words: Analytical Development | Method Development | Assay Development | MDV | Protein Characterisation | Product Characterisation | Protein Analysis | AAV | Viral Vector | Gene Therapy | GMP | QC | Quality Control | CMC | Biologics | Biopharmaceutical | C> | ATMP.
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Hands-on experience on LC-MS based assay development is highly desirable. The role's responsibilities include working with a cross-functional team of synthetic chemists, formulation scientists and analytical scientists to conceptualize and develop innovative non-viral gene therapy delivery approaches.
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Knowledge of gene editing and analytical chemistry (e.g., GC, HPLC) is favorable, along with a background in protein interaction assays. Independently manage molecular cloning experiments and assay development to construct DNA constructs and perform functional characterizations in microbial and plant systems.
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Conduct the first review of GC/MS and/or LC/MS/MS analytical data by each assay SOP. A Bachelor's degree in chemistry, analytical chemistry, or a related field. Experience working with biological specimens and/or analytical instruments (LC/MS/MS and/or GC/MS.
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This is a hands-on role, where the successful candidate will have strong experience with analytical assay development for nucleic acids (RNA) and LNP formulations. The scientist will be a vital part of the Technical Development team, playing a key role in shaping FL85’s analytical development capabilities.
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Working Knowledge of scientific principles for wide range of analytical techniques (HPLC, ELISA, Cell-Based Assay, Capillary Electrophoresis, etc.) Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Actively champions process improvement initiatives in the Project lead group, QC analytical group and inter-site collaboration (for co-validation, co-transfers etc)Actively involved in scientific discussions with the Analytical Formulation Sciences teamOther duties as assignedHow will you get here.
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Qualifications: PhD in Analytical Chemistry, Biochemistry, or Biotechnology and successful postdoctoral research training in a related field Minimum of 6 years of hands-on experience with liquid chromatography and tandem mass spectrometry (LC-MS/MS) approaches, and have excellent troubleshooting capabilities Strong analytical background with fundamentals in assay development, system suitability, and method evaluation Experience with discovery proteomics approaches (TMT, DIMS, SWATH, etc.
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Experience with protein purification using an AKTA system and protein characterization using HPLC (analytical SEC), SDS-PAGE, and mass spectrometry. This role will contribute to the growth of Belharra's research portfolio through the production of high value target proteins to enable biophysics, high-throughput screening, and general assay development.
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Skilled scientist able to discern the advantages and fir fall of a range of analytical techniques such as molecular assays (ddPCR, qPCR, RT-qPCR), flow cytometry, ELISpot, viral assays, cytokine assays, ligand binding assays and Mass SpectrometryIn depth knowledge of concepts such of context of use of fit for purpose assay validation in bioanalysisOverseen assay transfer, scientific quality and study conduct at CRO partners.
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Knowledge of multiple scientific principles and techniques, such as ELISA, western blotting, SDS-Page, CE, bioassays, viral titrations, serological assay, immunofluorescence, and proof of inactivation.
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Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of bioassay methods. Responsibilities:Perform routine/non-routine testing using diverse biological assay formats (e.g., cell-based, ELISA, qPCR.
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Develop new or optimize existing analytical release or characterization methods (CE or HPLC based) based on knowledge of biological and biochemical analytical techniques to support rAAV process development and product release/characterization.
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You have a Bachelor's or a Master's in Chemical Engineering, Bioengineering, Analytical Chemistry, Biochemistry, or a related field. Independently design experiments with an exceptional variable control for lateral flow assay development and optimization.
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