Quality Control, Lab Supervisor

The Quality Control Supervisor will lead the analysis of bioanalytical specimens obtained from animal studies and clinical studies conducted at contract research organizations and work closely with the Principal Investigator to ensure that these projects are assigned and completed. In addition, this individual will perform and teach the analytical procedures of production samples received from the manufacturing plant or the research and development laboratory. The individual will be required to follow, instruct and evaluate all Standard Operating Procedures (SOPs) and Test Methods (TSMs); Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and internal processes.

· Leads projects and is the resource for department team members for guidance and troubleshooting

· Foster positive morale and teamwork

· Expected to execute, tabulate data, and provide data interpretation

· Develop, qualify and validate robust bioanalytical methods for specimen analysis

· Serve as a lead for all bioanalytical analysis for all non-regulated as well as GLP and GCP studies

· Plan and perform experiments and lead internal projects

· Write and review study protocols and reports, validations, and analytical procedures

· Create and edit test methods and other quality documents

· Train new and current personnel

Qualifications

· Prior experience in bioanalysis on ICP-MS a plus

· BS or MS (preferred) in a related science such as Chemistry or Pharmacology.

· BS requires 3-5 years and a MS requires 1-3 years of previous related experience

· Prior leadership experience is a plus

· Strong computer, scientific, and organizational skills

· Ability to work multiple shifts

· Self-motivation, ability to multi-task, keep accurate records, and comply with cGMP/GLP regulations and internal policies

· Industry experience and understanding of the drug development process

· Familiarity with and able to apply statistical analysis tools

· Ability to adjust rapidly to changing scientific priorities