Responsibilities:
- Provide scientific support for translational biology efforts for Gene Therapy, RNA, siRNA, and Gene Editing programs.
- Lead and conduct GCLP/GLP clinical and non-clinical study sample analysis using ELISA, PCR, Western blot, NGS, and IHC/image analysis per SOPs.
- Lead and support development and validation of fit-for-purpose clinical and non-clinical biomarkers following FDA Bioanalytical Method Validation guidance.
- Operate in the in-house lab: train on established methods and execute bench experiments without supervision.
- Train team members on assays and sample processing/reporting workflows.
- Coordinate study activities and timelines; maintain sample testing trackers, summary statistics, and testing metrics.
- Document and present findings; author/review methods, SOPs, protocols, technical reports, and regulatory documents.
- Work with Quality Control/Quality Assurance to ensure regulatory compliance; participate in SOPs, technical reports, and publications.
- Process tissue, blood, urine, and other samples as needed; perform general lab tasks, preventive maintenance, and quality control peer review.
- Ensure compliance with relevant regulatory guidelines; may require extended hours/weekend/holiday coverage.
Qualifications/Requirements:
- Advanced degree in a scientific discipline required; M.S. in Biological Sciences or related field with 5+ years relevant lab experience (PhD preferred with 3β5 years).
- Ability to execute sample handling/analysis per lab methods, SOPs, and Good Documentation Practices (GDP).
- Demonstrated hands-on experience in protein-based and molecular biomarker analysis of biological samples.
- Extensive biomedical research methodology knowledge; analytical reasoning, problem-solving, and statistical grounding with software.
- Experience with GCLP/GLP assay development and bioanalytical method validation/testing.
- Proven scientific leadership in collaborative, multi-functional teams.
- Excellent technical writing and communication skills.
Application instructions:
- Not provided in the text.