QC Microbiology Specialist – Cell & Gene Therapy (GMP)

Job description

QC Microbiology Specialist – Cell & Gene Therapy (GMP)

Are you an experienced microbiologist eager to advance ground-breaking biopharmaceuticals? We are an expanding GMP organization in Western Sweden focused on cell and gene therapies (ATMPs), looking for an agile QC Microbiology Specialist to join our Quality Control team.

In this role, you will bridge hands-on analytical execution with quality oversight ensuring cleanroom compliance, leading microbiological contamination controls, and supporting routine aseptic operations.

Responsibilities

Desirable Skills

• 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.

Workstyle & Mindset

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!

Qualifications

Key Focus Areas

• 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.

Candidate Profile

• 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)

About the company

Randstad

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