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cell culture Engineer

Company: Aditi Consulting
Location: Thousand Oaks
Posted on: March 25, 2020

Job Description:

Job Title: Senior Process Engineer Duration: 12 months from start with possibility of extension Location: Thousand Oaks, CA 91320 -- Ideal Candidate- MS in Chemical/Biochemical Engineering and 3 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP). Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance -- Scope of work would include: Transfer processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation Provide routine process monitoring and troubleshooting Perform data trending and statistical process analysis Provide technical support for process related deviations (NCs), CAPAs and change controls Identify and support process related operational excellence opportunities Represent process development and interface with other functions such as Manufacturing, Quality, and Regulatory -- Basic Qualifications: Master's degree OR Bachelor's degree and 2 years of Process Development experience OR Associate's degree and 6 years of Process Development experience OR High school diploma / GED and 8 years of Process Development experience -- Preferred Qualifications: MS in Chemical/Biochemical Engineering and 3 years Process Engineering experience related to biochemical engineering and/or protein biochemistry, scale-up principles and manufacturing of biologics (cGMP) Experience working in/supporting a commercial cGMP manufacturing facility Upstream and/or Downstream process knowledge and hands on cell culture and/or purification pilot/clinical/commercial experience with regard to the manufacture of a biological drug substance A good understanding of cell culture process and associated equipment; scale up factors from bench to commercial, mass oxygen transfer capabilities, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes. Good knowledge of aseptic processing/techniques, harvest and clarification processes used in mammalian cell culture processes AND/OR A good understanding of purification process and associated equipment; chromatography, ultrafiltration, normal flow filtration, virus inactivation and virus filtration operations Process development experience in supporting cGMP manufacturing at large scale Person will have strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills Ability to develop and follow detailed protocols Independently motivated with ability to multi-task and work in teams Excellent written and verbal communication with experience with technical writing and presentations -- Top 3 Must Have Skill Sets: -- -- -- -- Cell culture and/or Purification routine process monitoring and troubleshooting GMP experience, at minimum 2 years in a relevant field Tech transfer of biologics processes Tech transfer of biologics processes -- Day to Day Responsibilities: -- -- -- Transfer processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operation Provide routine process monitoring and troubleshooting Perform data trending and statistical process analysis Provide technical support for process related deviations (NCs), CAPAs and change controls

Keywords: Aditi Consulting, Thousand Oaks , cell culture Engineer, Engineering , Thousand Oaks, California

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