Principal, Quality Control

Responsibilities

• Serve as the QC analytical SME for the design, development, and validation strategy for cell therapy release and stability methods
• Provide technical oversight for method transfers from Analytical Development or external labs
• Lead method qualification or validation strategy in alignment with ICH guidelines
• Author CMC quality sections for IND and BLA regulatory submissions
• Serve as QC SME during regulatory agency inspections and audits
• Drive continuous improvement initiatives within the QC laboratory
• Lead deviations, Change Controls, and CAPAs associated with QC methods and instrumentation

Requirements

• Expertise in cell therapy QC analytical methods including flow cytometry, PCR, and cell-based potency assays
• Comprehensive knowledge of ICH guidelines (Q2, Q6B, Q1E, Q9, Q14)
• Strong working knowledge of GMP-regulated laboratory operations and GDP principles
• MSc in Biology, Immunology, Cell Biology, Biochemistry, or related field with 15+ years of experience, or equivalent
• Ability to work in a fast-paced, start-up environment

Preferred Qualifications

• 10-15 years of experience in GMP biopharmaceutical operations
• 4+ years in cell therapy or lentiviral manufacturing
• 5+ years specifically in Quality Control
• Direct experience supporting BLA submissions and health authority inspections
• Experience with MasterControl
• Familiarity with contamination control principles and aseptic process simulation

About the Company

Lyell is a biotechnology company focused on developing life-saving autologous cell therapies. The company is committed to building an open, diverse, and inclusive culture.