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Sr. Specialist – Quality Control Cell Therapy
Company | Vertex Pharmaceuticals |
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Location | Boston, MA, USA |
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Salary | $94300 – $141400 |
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Type | Full-Time |
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Degrees | Bachelor’s, Master’s |
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Experience Level | Mid Level, Senior |
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Requirements
- 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.
- Bachelor’s or Master’s degree in biology, biochemistry, microbiology, or other related science is required.
- Minimum of 2 plus 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/validation, or technical support is required.
Responsibilities
- Execute and support analytical method technical transfer, qualification, validation 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/validation 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.
Preferred Qualifications
No preferred qualifications provided.