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Cogent Infotech Sr. Biopharmaceutical Technician... in St. Louis, Missouri

Job Description

Sr. Biopharmaceutical Technician - Downstream (Days) How will you make an impact? The candidate will be responsible for the performance of operations in support of the manufacture of Commercial and Clinical Biologics. He/She will be responsible for following Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture) and Downstream (purification) biopharmaceutical manufacturing. These functions may include but are not limited to activities such as propagation of mammalian cell culture, conducting aseptic cell culture operations, execution of large scare production bioreactors (50L - 2000L), conducting large scale chromatography, viral inactivation, viral filtration, ultrafiltration and diafiltration, as well as aseptic filling of bulk drug substance. What will you do? Execution of manufacturing batch records, work instructions and/or SOPs, with minimal instruction on a day-to-day basis and a focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation. Able to execute all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies. Acts as On-The-Job-Trainer for a variety of job functions Documentation of all activities to meet cGMP requirements. Execute document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback. Critical evaluation of processes, including foresight and thinking ahead. Complete preventative maintenance and work notifications tasks on time. Perform equipment testing and routine trouble-shooting. Ensure tasks are executed with a method of prioritization - interpret production schedules and complete tasks accordingly. Perform timely consumption of materials and completion of quality documentation in appropriate systems Identify deviations, aid in investigations/root cause analysis, and provide input on major/critical deviations. Work to complete documentation of deviations and events in appropriate systems Execute validation protocols with minimal supervision or direction Participate in cross-functional teams to complete projects Lead shift exchanges and daily huddles for team as required. Act as liaison with other groups within the manufacturing organization and a Subject Matter Expert on a variety of techniques. How will you get here? High school degree required. Bachelor’s degree in science or engineering preferred. 3-5 years of relevant experience in a related field or industry required Experience in GMP environment preferred Knowledge, Skills, Abilities Understanding ‘why’ and not just the ‘how’ of processes and practices Knowledge of cGMP practices required Knowledge of deviation investigations preferred Knowledge of chromatography, cell culture, and aseptic techniques strongly preferred Mechnical Skills/ Analytical Skills/Method Automation MS Office Strong math skills Strong prioritization skills Detail oriented Results driven Able to read, write, and communicate in English Able to understand and carry out instructions Reliable Strong communication (written and verbal) Effectively multi-task Able to work in an environment of change Able to work independently and as part of a team Able to recognize problems developing, not just occurring Additional Information Role: Contract to Hire Assignment duration: 6 months Possibility of assignment extension: If the candidate works out, I foresee a switch to full time Hours of Operation: Days - 6am – 6:30pm. This is a 2-2-3 schedule. 2 days on, 2 days off, Interview process: One, MS Teams Required experience to be considered: 3-5 years of Downstream manufacturing experience Intangible skills: GMP, Chromatography, Downstream processing