Senior Scientist, Technical Services | Molecular Biology and Validation | Winslow, ME | Contract 6+ Months
Responsibilities:
- Lead the design, execution, and reporting of qRT-PCR and qPCR method validation studies in accordance with VICH, USDA, and GMP guidelines, while performing routine and complex assay testing for product release, stability, and environmental monitoring
- Serve as the site SME for molecular methods, providing root cause analysis for OOS results and assay deviations, and identifying continuous improvement opportunities to optimize sensitivity, specificity, and throughput
- Develop and lead a training program and learning curriculum to ensure sustainable, replicable assay execution across the team, and collaborate cross-functionally with QC, R&D, and Regulatory Affairs on new product introductions and site transfers
Qualifications:
- Bachelor's or Master's degree in Molecular Biology, Virology, Microbiology, or a related discipline with 3 to 5 years of hands-on qPCR and qRT-PCR experience in a regulated biotech, pharma, or animal health environment
- Proven method validation experience within a GMP or GLP framework with direct exposure to USDA 9 CFR or equivalent regulatory oversight
- Proficiency in primer and probe design, nucleic acid extraction, and data analysis using platforms such as QuantStudio or Bio-Rad CFX, with strong technical writing skills and a quality-first mindset
Winslow, ME onsite. If you are a molecular biology specialist looking to bring your validation expertise to a meaningful and technically challenging role in animal health, send me a message or connection request to learn more.
