Quality Control Senior Specialist

Vertex Inc.•Boston, MA

1d•$94,200 - $141,400•Onsite

About The Position

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

Requirements

Demonstrated solid 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, e.g. GraphPad and JMP.
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 sciences, is required.
At least 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/validation, or technical support is required, preferably in cell-based therapy.

Nice To Haves

Familiarity with project management tools is a plus.

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.
Support generation and qualification of assay controls, standards, and critical reagents.
Lead data trending, invalid reporting, and continuous improvement.