The Manufacturing Supervisor will be very knowledgeable in basic synthetic/molecular biology skills (Mammalian Cell Culturing, MiniPrep, Transfection, Buffer Exchange, CE preparation) and will perform, train, and/or oversee the production staff on basic molecular biology workflows in a highly automated, high-throughput manner and will be responsible for the manufacture and analysis of a variety of custom IgG antibody products across Twist Bioscience's proprietary workflow according to SOPs for the daily production schedule. The Manufacturing Supervisor will be the main point of contact for shift operators, will assure the shift staff is working according to the plan of record, provide guidance, make decisions on priorities, and troubleshooting.
The Manufacturing Supervisor will be responsible for leading the pass down of information between shifts. The ideal candidate will work independently, be very neat and organized, have excellent molecular biology skills, maintain and build 5S systems, contribute to process improvement, and documentation, and communicate effectively with peers/management. The ideal candidate will have knowledge of good laboratory practices (GLPs) and familiarity working in GMP or ISO rated production, and experience leading and training others. The candidate must be comfortable working in a LEAN manufacturing/controlled laboratory environment.
What You'll Be Doing- Manufacture high-quality custom IgG products in a high throughput MFG lab according to established SOPs
- Plan, prioritize, and troubleshoot production orders with manufacturing team
- Manage, train, and mentor a team manufacturing associates
- Tracking of metrics to track the quality of product produced by both physical and functional test methods
- Summarize production progress, problems, and timelines to upper management
- Understanding of scientific principles in order to problem solve, troubleshoot test results
- Keen observation and attitude to proactively identify production problems/solutions, provide solutions on lab techniques, protocols, processes, handling of product and equipment
- Familiar with aseptic technique and cell culture
- Upholding standards as defined by the manufacturing process
- Supporting continuous cost/process improvement initiatives
- Working in a safe manner
- Maintaining/calibrating select lab equipment
- Leading shift pass down efforts and prioritizing workflows
- Accountability for the shift when senior personnel are not on site
- Acting as advisor to meet schedules and/or resolve technical problems and provides production guidance to junior MFG personnel
- Scheduling of staff
- Review and verification of production batch records, manufacturing documents
- Submission and writing of incident reports, CAPAs, planned deviations etc
- Follow regulatory and ISO 13485 requirements
What You'll Bring to the Team- A.S. or B.S. in Biology, Chemistry or Biochemistry
- Experience leading small teams within a laboratory environment
- 2-5 years lab experience in a manufacturing environment
- Experience with traditional molecular biology processes, instrumentation, and techniques especially sterile cell-culture, antibody quantitation, purification, and handling, DNA extraction, quantitation and handling
- Experience operating liquid handlers such as Hamiltons and Tecans is highly desirable
- Experience with sample tracking software and developing interfaces between robotic instrumentation and LIMS / MES systems
- Experience working within ISO, GMP, LEAN manufacturing environment and follow the lean manufacturing concepts
- Excellent scientific computation and data analysis capabilities
- Experience assessing current processes and techniques and implementing procedural improvements
- Good problem solving and communication skills
- 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 be able to work outside of regular work hours/work a flexible shift as needed
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