qc microbiology specialist – cell & gene therapy (gmp)

• Environmental Monitoring & Testing: Execute routine cleanroom EM (surface, air, and personnel sampling), incubate and read cultures, identify species, and perform sterility, endotoxin, and mycoplasma assays.
• Aseptic & Manufacturing Support: Oversee environmental conditions during production runs, providing real-time microbiology oversight during critical aseptic operations.
• Data Integrity & Investigations: Perform trend analysis on EM results, identify anomalies early, and lead root-cause analyses (RCAs) and CAPAs for contamination excursions.
• Quality & Assay Operations: Support viral vector and cell-based testing, author and update SOPs and monitoring protocols, and act as the subject matter expert (SME) for microbiological quality inside QC.

• Education: Master’s or PhD in Microbiology, Biotechnology, or a related biological science.
• Industry Experience: Minimum 1 year of hands-on cleanroom environmental monitoring within a regulated GMP framework.
• Technical Skills: Proven experience with cell culture, biological assays, microbial identification, and cleanroom gowning/behavioral standards.
• Language: Professional working proficiency in English (spoken and written)

• Hands-on familiarity with sterility isolator technology.
• Experience in molecular testing methods or viral vector characterization (AAV, lentivirus).
• Prior background in an ATMP or CDMO setting.

We are looking for someone with an analytical mindset, sharp attention to detail, and a proactive approach to continuous improvement. You thrive in a collaborative, evolving environment and enjoy taking ownership of technical tasks.

We look forward your application!