Associate I-II, QC Analytics (Contract, Multiple Positions)

Socket.dev; Waltham (MA); On-site; USD 69,000 - 100,000; Full time

Job summary

ElevateBio is seeking a QC Associate to support GMP testing in QC laboratories at our BaseCamp facility in Waltham. The role includes performing cell and molecular biology assays and basic lab maintenance to support gene and cell therapy programs.

You will perform routine testing, review data, assist in deviations/ CAPAs, and work with cross-functional teams to ensure timely completion of testing and qualification activities. The position is a 9-month contract with a competitive hourly rate.

Qualifications

• Bachelor's or Master's in Biology/related field with 1–5 years (Bachelor) or 1–3 years (Master) of GMP lab experience.
• Experience with cell and gene therapy test methodologies is preferred.
• Strong organizational skills, attention to detail, and ability to work independently and with cross-functional teams.

Responsibilities

• Perform routine GMP testing using established methods and report data.
• Peer-review data records and testing reports.
• Investigate testing excursions, deviations, CAPAs and OOSs as needed.
• Collaborate with QC and Analytical Development to meet timelines.
• Assist in drafting/editing procedures for testing and equipment.
• Assist with inventory management of reagents and daily lab operations.

Skills

GMP knowledge

PCR

Flow Cytometry

ELISA

Cell culture

Data analysis

Documentation

Education

Bachelor's degree in Biology/related

Master's degree in Biology/related

Tools

LIMS

CMMS

QMS

ERP

Job description

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 will support GMP testing in QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for performing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio's gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.

Here's What You'll Do

• Perform routine testing using established test methods, analyze the results, and record/report the data.
• Perform peer-review of data records and testing reports.
• Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.
• Collaborate with other QC functions to ensure all testing is completed within established timelines.
• Share responsibility with peers to manage inventory and reagents, and perform maintenance and other daily lab operations.
• Work cross-functionally with Analytical Development and other QC functions to assist in the qualification of developed assays.
• Assist in drafting and/or editing procedures for testing and/or equipment.

Requirements

• Bachelor's, or Master's, degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field). 1-5 years of experience with a Bachelor's, 1-3 years with a Master's.
• Experience working in a GMP setting preferred.
• Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
• Excellent organizational skills and attention to detail.
• Ability to work independently as well as communicate and collaborate with scientific/technical personnel.
• Experience performing laboratory investigations.
• Knowledge of GMP, SOPs, and Quality System processes.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

• Multiple positions available at Associate I, Associate II level.
• Contract length is 9 months.

• The budgeted range for this position is $33/hour - $48/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.