Quality Control Senior Specialist

General position summary:

The Senior Specialist, Quality Control provides technical support for Type 1 Diabetes (T1D) Cell and Casgevy Quality Control (QC). Executes and supports analytical method transfers, qualification, validation, and training to internal QC and external contract development and manufacturing organizations (CDMO).

• Execute and support analytical method technical transfer, qualification, and validation internally and externally, including flow cytometry, qPCR, cell count and viability, ELISA, and cell-based potency assay.
• Deliver documentation to support transfers (SOPs, qualification/validation protocols and reports) and train QC analysts.
• Support QC investigations of assay issues, Out-of-Specification, change controls, and deviations/CAPAs.
• Support generation and qualification of assay controls, standards, and critical reagents.
• Lead data trending, invalid reporting, and continuous improvement.

• Solid knowledge/skills in flow cytometry, cell-based assays, qPCR, and ELISA.
• Strong technical communication and technical writing.
• Proficient in MS Office and statistical analysis software (e.g., Graph Pad, JMP); familiarity with project management tools is a plus.
• Ability to manage multiple priorities with attention to detail; work independently and in a team.

• Bachelor’s or Master’s degree in biology, biochemistry, microbiology, or related sciences (required).
• 2–5 years of experience in the pharmaceutical/biopharmaceutical industry (or equivalent).
• Analytical QC, method development, method transfer/qualification/validation, or technical support experience (preferably in cell-based therapy).