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Senior Manager, Quality Control Liso-Cel CAR T in Summit, NJ



$100K - $150K*


Quality Management, Life Sciences


8 - 10 years

Job Description

The Senior Manager, QC Flow Cytometry is responsible for all operational aspects of the QC Flow Cytometry department at the CAR T manufacturing facility during clinical and commercial phases. This department is responsible for Flow Cytometry based testing of in-process samples, final drug product testing, stability testing, Validation and requalification support, critical reagent testing and qualification, training and other critical support as needed. The Senior Manager, QC Flow Cytometry is responsible to act as the SME during regulatory inspections.

Required Competencies: Knowledge, Skills, and Abilities

  • Extensive experience with flow cytometry and cell imaging, including flow related technologies related to analysis
  • Advanced knowledge of cGMP, ISO, FDA, MHRA, PMDA, USP, PDA, JP, and EP regulations and guidelines as related to the manufacture of cell therapy products.
  • Advanced verbal and written communication skil
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Valid through: 2020-4-3

About Celgene

Celgene Corporation is an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. It is incorporated in Delaware and headquartered in Summit, New Jersey. The companys major product is Revlimid, in combination with dexamethasone for the treatment of multiple myeloma patients. Revlimid is also approved in the United States for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk Myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid is sold through proprietary risk-management distribution programs to ensure safe and appropriate use of these pharmaceuticals. Vidaza is approved for the treatment of patients with MDS.
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* Ladders Estimates