Medix™
Location: San Antonio,TX, USA
Date: 2024-12-12T13:19:48Z
Job Description:
- Responsible for the performance of research projects, whether performed personally or delegated.
- Manage, and coordinate all research, early new product and/or service development, and specialty projects, including any clinical‐trial support and Investigational New Drug (IND) studies.
- Assist in managing the Center for Innovations and Biodesign, a part of BBG‐R&D.
- Conduct, supervise assigned regenerative medicine‐related research and development.
- Train and supervise junior staff and implement all relevant facility policies and procedures.
- Design and perform experiments for bioprocess development, optimization, and characterization.
- Conduct root‐cause analysis for unexpected results and provide new approaches or experimental strategies for problem solving.
- Conduct detailed in vitro characterization of cell therapy products using protein and gene expression analysis.
- Design and conduct experiments for individual bioprocess unit operations using relevant operational parameters and analytical inputs.
- Contribute to the development of next generation of new products, cell manufacturing and process engineering platform.
- Support internal product improvement efforts by providing biological performance data using bioreactors.
- Serve as Subject Matter Expert (SME) for bioprocessing.
- Design and execute experiments to drive innovative technology and platform evaluation for next generation
- advanced therapies and work collaboratively with downstream process development and analytical development teams.
- Execute adherent and suspension small‐scale bioreactor‐based cell culture processes for manufacturing of gene therapy vectors across multiple programs and disease areas to ensure on time delivery on goals.
- Collaborate with and participate in cross‐functional teams to facilitate IND‐enabling, clinical Phase I/II‐enabling activities as well as BLA enabling workstreams.
- Design and execute plans for method qualification per ICH and regulatory guidelines. Experience in cellular mechanism of action.
- Cell therapy upstream process development and analytics, including product characterization, process parameter optimization, and single‐use bioreactors.
- Design impellers for bioreactors using computational fluid dynamics approach.
- Drive successful technology transfer activities, writing protocols, reports, and performing and coordinating activities to support successful manufacturing with internal and external partners.
- Expertise with existing and emerging systems in this space together with troubleshooting is required.
- Data analysis using FlowJo, and GraphPad.
- Work with internal and external partners to test, optimize and advance new cellular therapies into early development and Phase 1 clinical trials.
- Regularly report back to supervisor on the progress of work. Summarize and present results to supervisor in a logical manner, verbally and in written reports.
- Present work at group and departmental meetings; contribute to the drafting of protocols, method development reports, and peer‐reviewed publications.
- Possess the desire and ability to work in a team environment under limited supervision.
- Contribute to lab and equipment maintenance and order supplies/reagents to help create a safe, effective and efficient working environment.
- Analyze, interpret, and present data, troubleshoot experiments, and provide an accurate summary to the management.
- Apply Quality by Design (QbD) methodology and Design of Experiments (DoE) approach in development tomaximize capacity and reduce cost of goods.