Quality Control Senior Specialist
Vertex Pharmaceuticals
June 27, 2026
On-site
Boston, MA
Operations
General position summary:
The Senior Specialist, Quality Control provides technical support for Type 1 Diabetes (T1D) Cell and Casgevy Quality Control (QC), including execution and support of analytical method transfers, qualification, validation and training to both internal QC and external contract development and manufacturing organizations (CDMO).
Key Responsibilities:
- Execute and support analytical method technical transfer, qualification, and validation internally and externally, including flow cytometry, qPCR, cell count and viability, ELISA, and cell-based potency assay.
- Deliver documentation to support transfer (e.g., SOPs, qualification/validation protocols and reports) and train QC analysts.
- Support QC investigations of assay issues, Out-of-Specification results, change controls, and deviations/CAPAs.
- Support generation and qualification of assay controls, standards, and critical reagents.
- Lead data trending, invalid reporting, and continuous improvement.
Minimum Qualifications (Knowledge and Skills):
- Solid knowledge and skills in multiple analytical techniques (flow cytometry, cell-based assays, qPCR, ELISA).
- Strong technical communication and technical writing.
- Proficient in MS Office and statistical software (e.g., GraphPad, JMP); familiarity with project management tools is a plus.
- Ability to manage multiple priorities, meet deadlines, and maintain attention to detail.
- Ability to work independently and in a team environment.
- Self-motivated with a can-do attitude and problem-solving skills.
Education and Experience:
- Bachelor’s or Master’s degree in biology, biochemistry, microbiology, or related sciences (required).
- 2–5 years’ experience in the pharmaceutical/biopharmaceutical industry (or equivalent).
- Experience in analytical Quality Control, method development, method transfer/qualification/validation, or technical support, preferably in cell-based therapy (required).
Pay range:
- $94,200 - $141,400
On-Site / Flex:
- On-Site designated; five days per week on-site with ad hoc flexibility.
The Senior Specialist, Quality Control provides technical support for Type 1 Diabetes (T1D) Cell and Casgevy Quality Control (QC), including execution and support of analytical method transfers, qualification, validation and training to both internal QC and external contract development and manufacturing organizations (CDMO).
Key Responsibilities:
- Execute and support analytical method technical transfer, qualification, and validation internally and externally, including flow cytometry, qPCR, cell count and viability, ELISA, and cell-based potency assay.
- Deliver documentation to support transfer (e.g., SOPs, qualification/validation protocols and reports) and train QC analysts.
- Support QC investigations of assay issues, Out-of-Specification results, change controls, and deviations/CAPAs.
- Support generation and qualification of assay controls, standards, and critical reagents.
- Lead data trending, invalid reporting, and continuous improvement.
Minimum Qualifications (Knowledge and Skills):
- Solid knowledge and skills in multiple analytical techniques (flow cytometry, cell-based assays, qPCR, ELISA).
- Strong technical communication and technical writing.
- Proficient in MS Office and statistical software (e.g., GraphPad, JMP); familiarity with project management tools is a plus.
- Ability to manage multiple priorities, meet deadlines, and maintain attention to detail.
- Ability to work independently and in a team environment.
- Self-motivated with a can-do attitude and problem-solving skills.
Education and Experience:
- Bachelor’s or Master’s degree in biology, biochemistry, microbiology, or related sciences (required).
- 2–5 years’ experience in the pharmaceutical/biopharmaceutical industry (or equivalent).
- Experience in analytical Quality Control, method development, method transfer/qualification/validation, or technical support, preferably in cell-based therapy (required).
Pay range:
- $94,200 - $141,400
On-Site / Flex:
- On-Site designated; five days per week on-site with ad hoc flexibility.