Scientist I-II Biomarker Specialist
Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy pioneers, Jude Samulski, PhD, and Xiao Xiao, PhD. We are driven to change lives with every clinical advancement and turn hope into cures with new possibilities for genetic medicine. We currently have clinical trials ongoing for late-onset Pompe disease and congestive heart failure.
AskBio is headquartered in Research Triangle Park, North Carolina, a thriving biotechnology hub, and has additional research and development facilities in Scotland and France and gene therapy manufacturing in Spain.
We are adding a Scientist I-II Biomarker Specialist – Translational Medicine to join the AskBio team!
About the role
We are seeking a highly motivated scientist to support our Translational Medicine team with biomarker discovery efforts for AskBio’s pipeline of gene therapy candidates in development, preclinical and clinical stages. The successful candidate will be effective in the designing, execution and troubleshooting of lab experiments using in vitro, ex vivo and/or in vivo stimulation models and subsequent biomarker assay development. The successful candidate will be expected to independently implement experiments, interpret data and troubleshoot issues to ensure delivery of completed data and analyses in support of key program milestones, and drive technical excellence in translational medicine and biomarker research within the organization.
- Lead/contribute to the biomarker strategy for pipeline and clinical programs
- Design, execute and implement biomarker assays using appropriate methods (ELISA/ECL/flow cytometry, MS, etc.) and interpret results
- Use relevant biomarkers to evaluate target engagement and mechanisms of action of gene therapy products and immune modulators in development
- Communicate study results effectively and guide stakeholders in applying those results to making strategic decisions
- Collaborate with key translational, pre-clinical, clinical, regulatory and product development colleagues to qualify and/or validate biomarker assays to address pre-clinical and clinical needs
- Support internal and external collaborations to increase team capabilities and to address strategic needs
- Take initiative to identify and support emerging technical approaches and platforms that may drive increased value for pipeline programs and the translational medicine group
- Assist with the preparation and review of protocols, clinical study reports and translational medicine sections of plans, INDs, manuscripts and technical reports
- Work closely with other lab-based personnel within translational medicine and product development to ensure optimal laboratory environment (collaboration, culture, safety, etc.)
- Demonstrate initiative, teamwork, collaboration and technical expertise as an independent and team player
- Follow best practices for data integrity complying with organization and company standard operating procedures in a timely fashion
- PhD with >2 years or MS with >6 years of relevant experience is required, preferably supporting gene therapy or cell therapy research in industry and/or academia
- Expertise in immunological assays, cell biology techniques and systems biology
- Proficiency using several platforms: multi-color flow cytometry, ELISA Luminex/MSD, microscopy immunofluorescence and LCMS is preferred
- Prior experience with data analysis tools, minimally flowjo, graphpad prism, JMP and systems biology platforms is preferred
- Prior experience with GxP or CLIA bioanalysis or clinical research is preferred
- Must be able to work in BSL2 or more environment
- Must possess basic computer skills such as using a PC and working with MS Office tools
- Must be self-motivated, organized, capable of working independently as well as a team contributor
- Must possess strong oral and written communication skills and excellent interpersonal skills with the ability to interact effectively with teams, internally and externally