Research Associate - III

Company: Intelliswift Software Inc
Location: Santa Monica
Posted on: May 16, 2022

Job Description:

Job Description This individual will be an integral member of the downstream process development of the viral vector programs at Client, contributing to the development, scale up and technology transfer of the viral vector production process. These activities can include ultrafiltration, microfiltration, chromatography, depth filtration, impurity characterization, scale-down model development and qualification, process optimization, robustness studies, and process characterization. Key Responsibilities --- Design and execute process development studies to develop a thorough understanding of operating and performance parameters and identify process efficiencies to be made --- Perform normal flow and tangential flow filtration operations, chromatographic separations, in-process analytical testing (UV spectroscopy, HPLC, gel electrophoresis, ELISA, turbidity) as required --- Develop manufacturing processes for viral vector products and support process scale up and implementation into GMP clinical production suites --- Perform process analysis and trend process performance --- Write and review technical documentation --- Selects appropriate methods and techniques in performing research and process. Required Skills: --- One or more of the following: normal flow filtration, tangential flow filtration (TFF), ultrafiltration, fast protein liquid chromatography (FPLC), column packing, or purification --- Demonstrated excellence in viral vector or biologics downstream process development, process technology transfer, scale translation, and statistical DOE (design of experiments) --- Excellent communication and presentation skills and aptitude for problem solving --- Experience with the preparation of regulatory filings for US and external markets is desired Qualifications: --- 5 years of experience with BS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline --- 2 years of experience with MS degree in Chemical/Biochemical Engineering, Biochemistry, Biology or a related scientific discipline --- Previous experience with TFF ultrafiltration for biologics or viral vectors is required. Experience with the development of viral vector purification process trains is desired. --- Previous experience with molecular biology and biophysical techniques (ELISA, HPLC, gel electrophoresis, PCR, particle size determination) is desired. --- Experience with statistical experimental design (i.e. DOE studies) and automation technologies is desired. --- Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired. Company Description Intelliswift Software, Inc. is a premier business and technology solutions company headquartered in the Silicon Valley, with offices across the United States, India and Singapore. The company has a proven track record of delivering results through its global delivery centers and flexible engagement models for over 450 brands ranging from Fortune 100 to growing companies. Intelliswift provides a variety of services including Enterprise Applications, Mobility, Big Data/BI, Staffing Services, and Cloud Solutions. Growing at an outstanding rate, Intelliswift has been recognized as the second largest private IT Company in the East Bay.

Keywords: Intelliswift Software Inc, Santa Monica , Research Associate - III, Other , Santa Monica, California