• Perform cGMP manufacturing activities for Upstream and Downstream operations according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule• Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards• Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates… Show more • Perform cGMP manufacturing activities for Upstream and Downstream operations according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule• Meticulously maintain facility records, batch records, and process/system records as required throughout the manufacturing process according to GDP standards• Through strict adherence to manufacturing controls, ensure finished drug substance/drug product and all intermediates comply with applicable regulatory requirements (e.g. FDA, EMA), cGMPs, QA/QC and safety standards• Ability to learn biopharmaceutical manufacturing processes including but not limited to: the use of autoclave, buffer preparation, cleaning, stocking, disinfectant prep, decontamination, fumigation, waste management, equipment maintenance, materials movement, staging, etc.• Adheres to the production schedule ensuring on-time delivery and efficient production logistics• Ability to utilize Quality Systems (Deviations, CAPAs, Change Control, etc.)• Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities• Build and develop team of direct reports, by hiring, providing coaching, training and professional development to employees• Work with team to improve production methods managing process change control to maintain compliance with the site quality requirements.• Direct the preparation and revision of department owned documentation. Ensure that all relevant documentation and procedures are up-to-date and effective.• Identify productivity savings and execute site improvements utilizing PPI, 5S, Lean, and Kaizen methodologiesAble to Perform: Downstream, Upstream, Buffer Solution Prep, Weigh & Dispense and Autoclave processes. Show less

Manufacturing Team Lead Technician IV JAN20221–FEB2022Manufacturing Team Lead MAR2020–JAN2021Manufacturing Lead Technician III SEP2018-MAR2020Manufacturing Lead Technician II JUN2018–SEP2018Manufacturing Technician I FEB2016-JUN2018Monitor production metrics during the shift to ensure daily goals are being achievedAdjust the manufacturing floor as needed to maintain adherence to… Show more Manufacturing Team Lead Technician IV JAN20221–FEB2022Manufacturing Team Lead MAR2020–JAN2021Manufacturing Lead Technician III SEP2018-MAR2020Manufacturing Lead Technician II JUN2018–SEP2018Manufacturing Technician I FEB2016-JUN2018Monitor production metrics during the shift to ensure daily goals are being achievedAdjust the manufacturing floor as needed to maintain adherence to the production schedule and metricsEnsure production personnel job performance meets or exceeds standardsPerform duties of Manufacturing Technician as requiredMaintain production metrics spreadsheetsPresent daily metrics at the Daily Production Gemba walkSchedule/Adjust work assignments of production personnel as needed to maintain adequate production flowMaintain an organized, safe and efficient work area at all timesEncourage production personnel to identify safety improvementsAssist production personnel in resolving job related problemsResolve routine issues and escalate non-standard or critical issuesSchedule training for production personnel as identified in the training planEnsure training is provided and successfully completedAssist Management in personnel related matters Provide inputs for merit reviews, recommend promotions, interview applicants and report potential problem areas in employee performance Develop employees by providing learning opportunities, cross-training opportunities and new challenges whenever possibleDevelop and foster a Team concept in the manufacturing spaceMentor production personnel as needed for job performance improvementWork with supervisor to provide rewards and recognition or needs for disciplinary actionDevelop relationships with supporting departments, including Safety, Planning, GIS, Supply Chain, Process and Equipment Engineering, and QualityEncourage suggestions from line personnel on ways to improve yield and reduce waste Show less

Tech 3 Lead JAN 2013 - FEB 2016Tech 2 OCT 2012 - JAN 2013Operator MAR 2012 - OCT 2012Manage a team of operators and technicians to efficiently and effectively produce products of highest quality. Often tasked do research and development projects. Typically reports to a supervisor or manager. Has gained full proficiency in a broad range of activities related to the job. Independently performs a wide range of complex duties under general guidance from… Show more Tech 3 Lead JAN 2013 - FEB 2016Tech 2 OCT 2012 - JAN 2013Operator MAR 2012 - OCT 2012Manage a team of operators and technicians to efficiently and effectively produce products of highest quality. Often tasked do research and development projects. Typically reports to a supervisor or manager. Has gained full proficiency in a broad range of activities related to the job. Independently performs a wide range of complex duties under general guidance from supervisors. Up to date with SOPs, MSOPs, GDPs, MRPs, GMPs. Validate and oversee development of Automated Production Line. Operates production equipment; responsible for manufacturing and assembly of clinical and commercial products. Follows blueprints, guidelines and/or diagrams to ensure product specifications and tolerance levels are met. Maintains required records of production and reports any inconsistencies or equipment issues following standard procedures. Troubleshoots problems and makes necessary adjustments to equipment set ups. May conduct testing of production output. May train and mentor new technicians. Show less