Job Description
Within this role you will be responsible to provide key technical support for internal and external technology transfer of biopharmaceutical drug substance manufacturing processes for monoclonal antibodies/therapeutic proteins and provide post transfer support.This is a 12-month temporary contract.As a Temp MSAT Specialist, a typical day will include, but is not limited to, the following:Assessing manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.Generating facility fit assessments and high-level gap assessments.Generating and reviewing documentation supporting technology transfer (e.g., master plans and reports, process descriptions, memos, detailed gap assessments).Presenting options to resolve technical challenges and seeking endorsement.Analysing process-generated data; summarizing findings in memos, reports, and presentations.Reviewing manufacturing documentation generated by the receiving unit (manufacturing records, batch sheets, changeover protocols, SOPs, etc.).Participating in study teams and investigations both internal and external.Troubleshooting technical difficulties as needed and prioritizing processes.Building process knowledge base, controls for technology transfer, knowledge management and lessons learned database while identifying continuous improvement activities to improve performance.This role might be for you if:You have a proven ability to work independently or as part of a team.You possess strong trouble-shooting and problem solving skills.You have strong attention to detail & excellent written and oral skills.To be considered for this opportunity you should have a BS/BA in an engineering or scientific discipline or equivalent combination of education and experience. #J-18808-Ljbffr