Associate II, Quality Control

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:

The QC Associate II will support cellular therapy product release testing within the QC analytical laboratory at our BaseCamp facility in Waltham. In this role, you will be responsible for analytical testing (cell and molecular biology assays) as well as excursion/deviation investigations and reports in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate will assist in qualifying and writing protocols for these assays. This role is a Wednesday-Saturday 10-hour shift.

Here’s What You’ll Do:

• Perform routine analytical tests, analyze results, and record data/report in LIMS.

• Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.

• Collaborate with other QC functions to ensure all testing is completed within established timelines.

• Work cross-functionally with QC Analytical Development to assist in the qualification and transfer of developed assays.

• Draft test methods/SOPs.

• Assist in the training of laboratory staff.

Requirements:

• Bachelor’s, or Master’s, degree in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3 years of experience, or 2 years with Master’s degree, preferably in a GMP QC laboratory setting.

• Experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).

• Excellent organizational skills and attention to detail.

• Ability to work independently and communicate/collaborate with scientific/technical personnel.

• Experience performing laboratory investigations.

• 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 $38.46 - $52.88. 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.