Full-Time
QC Specialist I
QC Analytics Cell Therapy, Multiple Positions
Confirmed live in the last 24 hours
Offers cell and gene therapy technology platforms
Industrial & Manufacturing
Senior
Waltham, MA, USA
Required Skills
Data Analysis
Requirements
- Bachelor’s or Master’s degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 5 years of experience, or 3 years with Master’s degree
- Experience in a GMP QC laboratory setting is preferred
- Significant experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA, and cell-based assays). Significant experience with flow cytometry is highly preferred
- Experience drafting test methods and associated qualifications/validations
- Experience performing laboratory investigations
- Ability to work independently and communicate/collaborate with scientific/technical personnel
- Excellent organizational skills and attention to detail
- Significant knowledge of GMPs, SOPs, and Quality System processes
- Experience in cell and gene therapy manufacturing environment is a plus
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus
Responsibilities
- Qualifying, writing/reviewing protocols, and executing cell and molecular biology assays for gene and cell therapy programs
- Investigating and reviewing excursions and deviations generated during qualification and testing
- Working cross-functionally with QC and Analytical Development to qualify and transfer developed assays
- Drafting and reviewing qualification/validation methods, test methods/SOPs, and reports
- Performing routine analytical tests, analyzing results, and recording data/report in LIMS
- Collaborating with other QC functions to ensure testing completion within established timelines
- Assisting in the training of laboratory staff
- Assisting with QC-related batch disposition activities
ElevateBio specializes in cell and gene therapies, offering integrated platforms for gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering. Their purpose-built manufacturing platform, BaseCamp, provides process innovation and cGMP manufacturing capabilities for viral vectors, RNA, and cell therapy production.
Company Stage
Series D
Total Funding
$1.2B
Headquarters
Waltham, Massachusetts
Founded
2017
Growth & Insights
Headcount