Technical Quality Control Senior Manager - Casgevy

Role overview

Duties and responsibilities

• Lead QC activities at one or more contract manufacturing and testing organizations, including release and stability testing, validation, and project timelines.
• Manage QC operations for a gene-edited hemoglobinopathy cell therapy product and troubleshoot analytical methods for biologics and cell therapy release.
• Manage commercial reference standards and assay controls to ensure compliance and continuity of supply.
• Troubleshoot analytical methods and equipment; author, review, or approve data, SOPs, COAs, methods, protocols, and reports.
• Ensure external laboratory records meet cGMP/GDP expectations and lead compliance teams pursuing continuous improvement.
• Lead OOS/OOT investigations and deviations and help identify corrective actions to prevent recurrence.
• Work independently and communicate key risks to management.

Knowledge and experience

• Bachelor's degree in science or a related discipline is required.
• Typically requires 8 years of pharmaceutical or biopharmaceutical industry experience, or an equivalent combination of education and experience.
• Strong knowledge of US and EU cGMP regulations and guidance; some experience with regulatory agency inspections.
• Experience in several quality processes, including batch release, OOS/OOT investigations, reference standards/assay controls, stability studies, LIMS, or raw materials testing.
• Laboratory experience with biologics or cell and gene therapy release assays; working knowledge of compendial assays and GMP drug-product safety testing.
• Experience managing GMP external contract test laboratories.
• Effective verbal and written communication skills.

Work arrangement

• Hybrid designation allows remote work up to two days per week, or an on-site designation of five days per week with ad hoc flexibility.
• Flex status is subject to company policy and may change.