Our client is seeking a Method Transfer & Validation Scientist to support the Quality Control organization within vaccine manufacturing. This individual will play a key role in transferring, validating, and maintaining microbiological test methods to ensure product quality, compliance, and readiness for next-generation production needs.
This role is highly hands-on and lab-focused, requiring a strong microbiology background and experience working in a GMP-regulated environment.
Key Responsibilities
- Support method transfer activities for microbiological assays related to vaccines across internal sites or external partners
- Execute and document method validation, verification, and qualification protocols in alignment with regulatory expectations (FDA, EMA, ICH)
- Perform routine and non-routine microbiological testing, such as:
- Bioburden
- Endotoxin testing
- Sterility testing
- Microbial identification
- Environmental monitoring support (as needed)
- Author and review technical documentation, including protocols, reports, SOPs, and deviations
- Participate in investigations (OOS/OOT, deviations) and support root cause analysis and CAPA implementation
Required Qualifications
- Bachelor's degree in Microbiology, Biology, or related life sciences field (Master's preferred)
- 3–7+ years of experience in a GMP-regulated pharmaceutical or vaccine environment
- Strong hands-on experience with microbiology testing methods and QC lab operations
- Proven experience with method transfer, validation, or verification within a QC setting
- Familiarity with aseptic techniques and controlled environments
- Experience working with regulatory guidelines (FDA, USP, ICH)
