Supervisor, IgG Production

Responsibilities

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

Requirements

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