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Sr. Specialist – Quality Control Cell Therapy

Sr. Specialist – Quality Control Cell Therapy

CompanyVertex Pharmaceuticals
LocationBoston, MA, USA
Salary$94300 – $141400
TypeFull-Time
DegreesBachelor’s, Master’s
Experience LevelMid Level, Senior

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.