Manufacturing Lead, IgG Production

The Manufacturing Lead will be responsible for the manufacturing and analysis of a variety of gene products across Twist Bioscience’s proprietary process workflow to meet the Twist production forecast and timelines. The Manufacturing Lead will be held accountable for maintaining production schedule and troubleshooting, guiding the work of other shift associates while also performing manufacturing tasks. Activities will include but not be limited to: operating a variety of laboratory equipment including liquid handling robots, maintaining detailed documentation, cleaning and restocking the lab, and practicing good lab bench techniques to ensure high quality and consistent products. The ideal candidate will be driven and will do what it takes to keep manufacturing on track in a fast paced start-up environment. The Manufacturing Lead will also be responsible for the production of genes and various intermediates according to established SOPs and complete manufacturing batch records to contribute to the daily production schedule. What You’ll Be Doing Assisting the production supervisor and guiding the work performed on the manufacturing floor by manufacturing associates. Troubleshooting all processes related to manufacturing process and instrumentation. Taking responsibility for daily operations when the supervisor is not available. Maintaining daily operations w/ or w/o the supervisor (equipment maintenance, fulfill production request, retain review) Reviewing time sensitive material and calendar events. Overseeing material inventory and waste management activities for the shift. Monitoring the flow of intermediate products through the Manufacturing Execution System (MES) and notifying the supervisor of any discrepancies. Reviewing JIRA tickets with supervisor to create action items. Enforcing checklist and auditing activities which are built into the production process. Training new laboratory manufacturing associates. Working in the laboratory and performing any process tasks. Manufacturing high quality custom oligo containing products in a high throughput MFG lab according to established SOPs. Operating laboratory equipment and liquid handling robots (Hamilton Stars, centrifuges, sealers, thermocyclers, spectrometers, Illumina Next-Gen sequencers etc.) Effectively using molecular and cell biology processes and techniques, especially PCR, DNA quantitation, purification and cloning. Maintain thorough, accurate and detailed documentation of all work performed using existing document templates and applications. Updating and writing work instructions and documentation. Working independently and in a safe manner. Paying great attention to detail and yielding consistent results. Performing troubleshooting and handling process deviations correctly. Analyzing data outcomes from manufacturing steps and deciding on or recommending a course of action. Following lean manufacturing, ISO and GMP practices. What You’ll Bring to the Team Bachelors/Associates degree in biology, chemistry, biochemistry: degree preferred but will consider candidates with relevant laboratory experience Familiarity or prior experience in a manufacturing environment Good written and verbal skills Good computer skills and comfort in using computers for all aspects of MFG, experience with excel and word, Jira/Confluence, web based or similar programs Physical Requirements Ability to work in a controlled laboratory environment Must be able to stand for long periods of time while performing duties Must be able to work safely with chemicals and hazardous materials Must be able to lift up to 20 lbs Must have flexibility to work outside of regular work hours/work a flexible shift as needed

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