The primary role of the QC Raw Materials Manager is to manage the QC Raw Material testing program in support GMP manufacturing. This role will work closely with the other QC personnel, Quality Assurance, Manufacturing, Process Development, Analytical Technologies and Supply Chain to ensure incoming raw materials are sampled and tested in a timely manner to support manufacturing operations. This includes but is not limited to the following:

• Manage the Raw Material Program in compliance with current GMPs, USP, ICH and FDA guidance documents which includes developing raw material strategies, perform risk assessments and routine raw material testing
• Serve as the subject matter expert for raw materials providing technical expertise aligned with cGMPs, compendial requirements and industry expectations
• Provide oversight to internal and external raw material testing which includes review and approval of test data
• Coordinate and manage external contract testing labs which includes shipping samples, tracking progress and managing timelines
• Assists with method transfers and method validations
• Evaluate the current raw material program and implement improvement where needed to ensure compliance with current regulatory requirements
• Working closely with QA to support the Supplier Qualification program
• Evaluate changes to existing raw materials and potential new raw materials to revise or establish release and qualification requirements
• Author, review and approve out of specification and out of trends investigations, deviations, CAPA’s and Change Controls
• Manage the Compendial program by assessing changes to the compendia and lead change for revised compendial testing and monographs where applicable
• Serve as an active member of the Material Review Board
• Author and review CMC sections for regulatory submissions

REQUIREMENTS:

Minimum Education/Experience

• Bachelor’s or advanced degree in biology, biochemistry or closely related scientific discipline with at least 8 years of cGMP QC experience in cell therapy, biotech, pharmaceutical setting
• At least 3 years of raw material management experience plus expertise in compendial testing and monographs is required
• Knowledge of current industry standards and expectations (cGMP/GxP, ICH, Compendial, FDA guidances) is required
• Analytical method transfer and validation experience is desired
• Experience in leading projects