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RD Scientist - Cellular Manufacturing

Company: CSL Behring
Location: Pasadena
Posted on: May 16, 2019

Job Description:

The R & D Scientist-Cellular Manufacturing will be responsible for assay and process development for clinical cell manufacturing processes. (S)He will develop, validate, and standardize cell manufacturing methods, transfer methods internally and externally where required, perform routine assays in support of cell manufacturing activities, release tests, and/or patient sample analysis where required and report results, and maintain laboratory quality systems and records of cell manufacturing results.Responsibilities: - Perform process development efforts to optimize cell manufacturing processes - Perform all aspects of clinical cell manufacturing processes in accordance with cGMP. - Drafting of Test Procedures and Standard Operating Procedures (SOP) for cell manufacturing processes. - Performing cellular and molecular assays. Analytical methods include qPCR, RT-qPCR, cell- and CFU- based assays, and flow cytometry. - Documenting the cell manufacturing process and test results within batch records, and reporting results as required. - Collating, presenting and analyzing cell manufacturing process development results and experimental data, including statistical analysis. - Working independently and as part of a team, perform experimental work and report results. - Perform Technical Transfer of methods in and out of department. - Present data at departmental or project meetings. - Initiating change controls for documents or procedures, closing out change controls by training of staff. - Representing the department on the R & D Safety Committee, or similar representative role, as required. - Performing routine maintenance on scientific instrumentation, as required. Liaising with instrument engineers for repair and maintenance of equipment. - Ensuring critical instruments are calibrated and calibration records maintained. - Perform quality control testing of items, as required. - Ensure that inventories are maintained for materials, reagents, consumables and samples. - Ensure that high safety standards are taken into account and adhered to as governed by local, state and federal regulations, laws and policies as well as CSLs policies and directives. Essential Qualifications/Experience: - A bachelor degree in a science or engineering related discipline. - At least three years laboratory experience in biomedical research with an emphasis on cultivation of mammalian cells. - Higher postgraduate qualification in science or engineering, e.g., PhD is highly regarded. Essential Skills, Knowledge & Attributes: - Experience in cell enrichment, isolation and culture of human hematopoietic cells. - Experience in transduction and transfection of reporter constructs. - Experience in multicolour flow cytometry and immunophenotyping. - Experience in DNA and RNA isolation and characterization (qPCR, RT-qPCR, ddPCR). - Outstanding verbal and written communication skills in English. - Well organised, able to plan work appropriately. Attention to detail. Mechanical aptitude and problem-solving skills. - Ability to work effectively in a team - Competence in assay validation, QC/QA, data analysis and reporting. - Understanding of regulatory requirements in drug development. - Good working knowledge of Word Processing, Spreadsheets, and general PC familiarity and usage. Worker Type:Employee Worker Sub Type:Regular

Keywords: CSL Behring, Pasadena , RD Scientist - Cellular Manufacturing, Other , Pasadena, California

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