Quality Control Senior Specialist

Job Description

General position summary: 

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.

Key Responsibilities:

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

• 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.

Minimum qualifications:

Knowledge and Skills:

• 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. 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 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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]