Bachelors degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
5-8 years of experience in Quality Control within biologics or pharmaceutical manufacturing environments.
Understanding of USDA, USFDA, ICH, EU, and Health Canada regulations, as well as USP and other pharmacopeial standards.
Experience supporting regulatory inspections and third-party audits.
Working knowledge of biologic analytical techniques and validation of methods.
Experience in quality systems, qualifications and validations, and product lifecycle quality management.
Proven track record in driving continuous improvement projects.
Experience in bioanalytical and bioassay methods for monoclonal antibodies and other biologic molecules.