Laboratory and Quality Control Manager

Position Purpose Stands up the on site laboratory and the product quality system. The plant cannot release product or troubleshoot a batch without a working lab, and the lab has to be running before the first fermentation. Key Responsibilities Design, equip and commission the on site laboratory, including analytical instrumentation, microbiology capability and safe handling of samples and reagents. Develop and validate analytical methods for raw materials, in process samples, intermediates and finished product. Own the product specification, certificate of analysis process and release procedure. Build the sampling plan across the process and the microbiological monitoring program for contamination control. Establish the quality management system, including document control, deviation handling, out of specification investigation and change control. Manage laboratory technicians and set the shift coverage model to match production. Own instrument calibration, maintenance and reference standard control. Manage external laboratory relationships for methods held off site. Required Qualifications Bachelor's or master's degree in chemistry, biochemistry, microbiology or a related field. Seven or more years in an industrial analytical or quality control laboratory, including supervisory responsibility. Hands on method development and validation experience with HPLC, GC and titrimetric methods. Microbiological testing and contamination investigation experience. Preferred Qualifications Experience commissioning a laboratory from empty space. ISO 17025 or ISO 9001 quality system experience. Organic acid or monomer analysis experience. #J-18808-Ljbffr LAMP