Specialist I, QC Analytics (Wed-Sat Shift)
Summary
Performs and qualifies cell and molecular biology assays (e.g., Flow Cytometry, PCR) in a GMP QC lab to release gene therapies, investigates deviations, and drafts test methods.
ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role:
In this lab-based role, the QC Specialist I will support product release testing within the QC analytical laboratory at our BaseCamp facility in Waltham, MA. In this role, you will be responsible for qualifying, writing/reviewing protocols for, and executing cell and molecular biology assays for ElevateBio’s gene therapy programs. Additionally, the QC Specialist I will investigate and review excursions and deviations generated during qualification and testing.
Here’s What You’ll Do:
- Work cross-functionally with Analytical Development to transfer and qualify developed assays
- Lead drafting and review of methods, and qualification/validation procedures and reports for cellular assays such as Flow Cytometry
- Perform routine molecular and cellular analytical tests; review, analyze, and communicate results
- Investigate and review analytical testing excursions including deviations, CAPAs and OOSs
- Assist in the training of laboratory staff
- Collaborate with other QC functions to ensure all testing is completed within established timelines
Requirements:
- Bachelor’s, or Master’s, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 3 years of experience, or 1 years with Master’s degree
- Experience in a GMP QC laboratory setting is preferred
- Experience with techniques such as PCR, Flow Cytometry, immunoassays, cIEF required
- Significant experience with flow cytometry is strongly preferred
- Experience in a GMP QC laboratory setting and/or drafting of test methods and qualifications is strongly preferred
- Excellent organizational skills and attention to detail
- Ability to work independently and communicate/collaborate with scientific/technical personnel
- Significant knowledge of GMPs, SOPs, and Quality System processes.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus
The budgeted range for this position is $43/hour - $57/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.