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Genezen

QC Analyst - Bioassay

1w

Genezen

Lexington, US · Full-time · $75,000 – $95,000

About this role

The field of gene therapy is growing rapidly and Genezen meets the exacting needs of clients by providing process development, GMP viral vectors, and cell transduction for clinical trials leading to new cures. The QC Analyst role performs routine and non-routine QC testing within the Bioassay team in a GMP laboratory. This position supports daily Quality Control operations through cell-based testing, routine lab support, and Quality Systems.

Responsibilities include execution of in-process testing, lot release testing, and stability testing in accordance with cGMP guidelines, departmental policies, and standard operating procedures. The role involves cell-based assays such as q-PCR, ddPCR, cell culture, and ELISA. Initial training occurs on first shift with occasional support outside standard hours.

Genezen fosters an innovative, collaborative environment where employees are problem solvers dedicated to a fast-growing company. Every employee contributes to company success as part of a rewarding team. The culture empowers individuals to be their best while tackling challenges together.

Team members work as active participants in internal and cross-functional groups, communicating gaps proactively to leadership. Opportunities include peer review as subject matter expert, training analysts, and involvement in method qualifications and validations. This role offers impact in a state-of-the-art facility advancing gene therapy.

Requirements

  • BA/BS in Biochemistry/Cell Biology or other related science
  • Minimum 2 years’ laboratory based experience within QC testing capacity, preferably in cGMP environment
  • High proficiency in cell culture and cell-based assays
  • Understanding of industry testing requirements/standards
  • Strong understanding of GxP regulations, ability to apply to any situation, and identify deficiencies with some guidance
  • Proficiency in computer applications including MS Word, Excel, and LIMS (preferred)
  • Good/effective communication, organizational, and time management skills with the ability to work well with others and independently
  • Flexibility and willingness to learn, with a proactive approach to making a positive impact

Responsibilities

  • Perform routine/non-routine cell-based testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, ddPCR, cell culture, ELISA)
  • Perform peer review as SME of assay data with minimal errors
  • Participate in equipment validation, method transfer/qualification/validation, critical reagent qualification and special protocol execution as required
  • Review/generate protocols and reports, as required
  • Establish, revise, review and maintain standard operating procedures
  • Promptly and proactively communicate gaps to leadership
  • Work as an active member of internal/cross-functional teams
  • Train other analysts, as required