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.