Director of Quality Control

DirectorAssociate Director of Quality Control (QC)We're partnering with a leading cellular therapy organization that is seeking a highly motivated Director or Associate Director of Quality Control (QC) with expertise in ddPCR, flow cytometry, and cell-based assay methods. This role offers an exciting opportunity to lead quality initiatives supporting cellular therapies within a GMP environment.Key Responsibilities:Conduct GMP In-Process Control (IPC), lot release, and stability testing using ddPCR, flow cytometry, and cell-based methods.Lead method optimization, transfer, qualification, and validation for clinical drug product testing.Prepare detailed and organized reports and presentations describing analytical results.Facilitate cross-functional training and continuous improvement within the QC team.Develop and maintain Quality Control (QC) and Quality Management System (QMS) standards to align with internal and global regulatory requirements.Oversee stability studies, raw materials qualification, and analytical development strategies to ensure product quality.Manage method transfers and outsourced testing activities with CMOs.Write, review, and approve protocols, validation reports, and regulatory submissions.Qualifications:Bachelor's degree in Biology or related field; advanced degree preferred.8+ years of QC laboratory experience within biotechnology, clinical, or pharmaceutical environments, ideally under GMP, GLP, or CLIA -depth knowledge of FDA, ISO, EMA, GMP, and ICH standards applicable to biologics and cell therapies.Hands-on experience with multicolor flow cytometry, ddPCR, ELISA, cell-based assays, and cell culture techniques.Proven ability to lead high-performing QC teams, manage complex projects, and collaborate effectively with stakeholders.Experience with regulatory submissions, particularly those leading to commercial product approval.Excellent communication, organizational, and problem-solving skills.This full-time position is based in San Diego, CA, and offers an opportunity to make a significant impact in the cellular therapy field.

Created: 2024-11-06