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Job Description

General position summary:

The Senior Specialist, Quality Control provides technical support for Type 1 Diabetes (T1D) Cell Quality Control (QC). This includes execution and support of analytical method transfers, qualification, and training to both internal QC and to external contract development and manufacturing organizations (CDMO). This position reports directly to the Quality Control Manager, VCGT.

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Execute and support analytical method technical transfer and qualification both internally and externally including, flow cytometry, qPCR, cell count and viability, ELISA, and cell-based potency assay, etc.
• Participate in delivery of appropriate documentation to support transfer, such as SOPs, qualification protocols and reports, and training of QC analysts.
• Support QC in investigation of assay related issues, Out-of-Specification, change controls, and deviations/CAPAs.
• Assist in qualification of controls, standards, and critical reagents.
• Assist in monitoring assay performance and driving continuous improvement.

Knowledge and Skills:

• Demonstrated knowledge and skills in multiple analytical techniques such as flow cytometry, cell-based assays, qPCR, and ELISA.
• Strong technical communication and technical writing skills.
• Proficient in MS Office, and Statistical analysis software. Familiarity with Project management tools is a plus.
• Ability to handle multiple priorities and deliverables in a timely manner and attention to detail.
• Ability to work independently and in a team environment.
• Self-motivated individual with a can-do attitude and problem-solving skills.

Education and Experience:

• Bachelor’s or Master’s degree in biology, biochemistry, microbiology, or other related science is required.
• Minimum of 2-5 years of experience in the pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience.
• Experience in analytical Quality Control, method development, method transfer/qualification, or technical support in cell-based therapy is required.

#LI- Onsite

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