Quality Control Manager - Cell Therapies

Responsibilities

• Provide oversight of analytical functions in the QC department to support testing and reporting of in-process, release, and stability samples for cell therapies
• Manage laboratory programs including assay readiness, training, sample management, and data review
• Coordinate laboratory activities to ensure on-time delivery of commitments
• Author, review, and approve data, SOPs, and laboratory records in adherence to cGMP/GDP expectations
• Lead OOS/OOT investigations and deviations, identifying corrective actions to prevent reoccurrence
• Coach and develop direct reports, providing guidance on technical and professional issues
• Serve as the QC representative in cross-functional working teams and with outside vendors

Requirements

• Bachelor's Degree in science or a related discipline
• 8 years of experience in the pharmaceutical or biopharmaceutical industry
• Strong knowledge of US and EU cGMP regulations and guidance
• Proficiency with analytical methodologies such as flow cytometry, cell-based assays, qPCR, ELISA, BACT, or endotoxin
• Ability to prioritize multiple projects and adhere to strict timelines

Benefits

• Medical, dental, and vision benefits
• Generous paid time off, including a week-long company shutdown in the Summer and Winter
• Educational assistance programs and student loan repayment
• 401(k) with company matching
• Annual bonus and annual equity awards

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to advancing clinical and research programs for life-shortening genetic diseases and other serious conditions.