QC Analyst II/III - Analytical

1w1 week ago

Genezen

Lexington, US · Full-time · $80,000 – $100,000

About this role

The field of gene therapy is growing rapidly and Genezen provides process development, GMP viral vectors, and cell transduction for clinical trials leading to new cures. The QC Analyst II/III performs routine and non-routine QC testing according to SOPs in a GMP laboratory. This role is based at Genezen’s state-of-the-art facility in Lexington, MA.

Daily responsibilities include execution of in-process, release, and stability testing via analytical methods like q-PCR, HPLC (SEC, IEX, rpHPLC), ELISA, Western Blot, and CE-SDS. The position supports daily operations and occasional 2nd shift or weekend needs within Quality Control. Quality Systems tasks cover deviations, CAPAs, investigations, OOS, and change controls per cGMP guidelines.

Employees work as innovative, collaborative problem solvers in a fast-growing company dedicated to empowering staff. Team members contribute directly to company success in internal and cross-functional teams. Peer review of assay data occurs as subject matter expert with minimal errors.

Opportunities include training cross-functionally to meet release deadlines, participating in equipment validation and method qualification. Establish and revise SOPs, generate protocols and reports. Support internal and external audits while proactively communicating gaps to stakeholders.

Requirements

BA or BS in Chemistry/Biochemistry or other related science
Minimum 2-5+ years (Analyst II) and 5–8+ (Analyst III) of laboratory background
Strong understanding of regulations, able to apply to situations and identify deficiencies with some guidance
Adaptability required as work schedule may change based on business needs
Flexibility to support 2nd shift STAT testing on a monthly rotational basis, may include holidays
Criminal background check required
Experience performing analytical testing in GMP laboratory environment
Familiarity with cGMP guidelines and Quality Systems including CAPAs and OOS investigations

Responsibilities

Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples (q-PCR, HPLC (SEC, IEX, rpHPLC), ELISA, RI, HIAC, DLS, Osmolality, Western Blot, CE-SDS, etc.)
Perform peer review as SME of assay data with minimal errors
Work effectively in internal/cross-functional teams as an active member
Train and execute assays cross-functionally to support deadlines for release
Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution
Responsible for protocol and report generation/revision/review
Establish, revise, review and maintain standard operating procedures
Responsible for Quality Systems such as deviations, investigations, CAPAs, OOS, change controls