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).

Key Responsibilities:
- 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.

Minimum Qualifications / Knowledge & Skills:
- 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., GraphPad, JMP); familiarity with project management tools is a plus.
- Ability to manage multiple priorities with attention to detail; work independently and in a team.

Education & Experience:
- 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).