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... and contract laboratories Requirements/Experience: BS with 13 years, MS with 10 years and PhD with 7 years industry experience in the development and analysis of biologics, pharmaceutical or vaccine products Strong technical competency, oral and written communication skills Strong hands on cell ...
... and residual assays) and support product release and characterization testing Qualify/validate analytical assays for the current stage of clinical development, and manage analytical transfer activities between labs Manage analytical assays at contract labs to ensure assay performance/compliance ...
... position requires relevant experience of 5 to 8 years with a Bachelor's degree OR 2 to 5 years with a Masters degree in cell therapy and cell culture process development experience. Associate Scientist II position requires relevant experience of 8 to 10 years with a Bachelor's degree OR 5 to 8 years ...
... residual assays) and supports product release and characterization testing Qualifies/validates analytical assays for the current stage of clinical development, and manages analytical transfer activities between labs Manages analytical assays at contract labs to ensure assay performance/compliance ...
... and externally. Rockville Career Job Do you need more training in ms office to qualify for this job? Sr. Staff Scientist - Downstream Process Development Job Requirements • Develop robust, high-yield and scalable purification process (recombinant protein and Virus like Particles) for Vaccine ...
... data interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission Keeps current with advances in cell line development for viral vector production Ph.D. with 3 years, or MS with 8 years in Cell/Molecular Biology, Virology or equivalent Hands-on experience ...
... role, the Scientist I/II/III works on technical problems in analytical chemistry that directly support revisions to the USP-NF. These include development or validation of analytical procedures supporting the identity of the drug or drug product. The Scientist I/II/III has experience in a broad range ...
... Compliance using Design of Experiment (DOE) methods. • Lead efforts to evaluate different resins, filters, and analytical methods pertinent to purification development activities. • Perform experiments using AKTA series Chromatography skids, TFF systems, and industry standard Harvest methods scale ...
... and report writing. *Skills in performing scientific presentations and preparing scientific publications ESSENTIAL JOB FUNCTIONS The focus of Development Services is to provide relevant technical and regulatory support to both internal and external clients as well as providing regulatory compliance ...
... preferred Familiar with process characterization using Design of Experience (DoE), Quality by Design (QbD) preferred Experience in formulation development preferred Familiarity with FDA guidance and quality systems preferred Experience in a cGMP environment preferred *The position will be Associate ...
... culture, viral sub-unit antigen production and/or viral vector production • Must be able to execute experiments independently • Contribute to the development and transfer of upstream processes • Work on multiple projects internally, at other sites and at external manufacturers requiring initiative ...
... interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission Keeps current with advances in cell line development for viral vector production Requirements/Experience: Ph.D. with 3 years, or M.S with 8 years in Cell/Molecular Biology, Virology or equivalent ...
... Knowledge about different transfection methods Significant experience in developing and improving cell lines/clones for scalable upstream process development Must be familiar with DNA sequencing technologies and analysis of DNA sequencing data, multiple sequence alignments, identification of mutant ...
... Compliance using Design of Experiment (DOE) methods. • Lead efforts to evaluate different resins, filters, and analytical methods pertinent to purification development activities. • Perform experiments using AKTA series Chromatography skids, TFF systems, and industry standard Harvest methods scale. ...
... III / Sr. Scientist III works on technical problems in analytical chemistry that directly support revisions to the USP-NF. These include development and/or validation of analytical procedures supporting the identity, strength, quality, and purity of the drug or drug product. The Scientist III / Sr. ...
... analyze resulting data using appropriate software Preferred qualifications: • Knowledge of equipment and procedures relating to upstream process development for the manufacture of vaccines. This includes a strong understanding of scale-up of bioreactors, multiphase mixing models, and mass transfer ...
