Scientist II-IV Upstream Process Development
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 Edinburgh, Scotland, and gene therapy manufacturing in San Sebastian, Spain.
We are excited for our next SCIENTIST II-IV Upstream Process Development to join the AskBio team!
About the role
The Scientist II-IV Upstream Process Development will develop upstream (cell culture) processes for production of recombinant adeno-associated virus (rAAV) vector gene therapies. This individual will work with a team of associates and scientists on upstream process development, scale-up, optimization, characterization and transfer of projects, while providing scientific expertise, guidance and development opportunities.
Responsibilities and Accountabilities
- Demonstrates innovative design, development and execution of process development projects through literature review and scientific teamwork
- Assess and interpret experimental data using DOE and other statistical techniques
- Develops robust, scalable, transferable processes for upstream production of rAAV clinical gene therapy vectors
- Serve as a Subject Matter Expert (SME) for the development of robust, high performing upstream processes with emphasis on transferability to cGMP manufacturing that supports regulatory filings
- Training new or current team members and delegating tasks appropriately
- Provide input on the acquisition of capital equipment
- Assist in the generation of project and cost proposals, timelines and work plans by applying scientific knowledge and project management experience
- Writes study reports, process characterization reports, transfer documents, and regulatory documents
- Authors manuscripts and presents results at scientific meetings
- Contributes to building a culture that embraces continuous learning and innovation, while encouraging team members to expand their technical skills and deepen their gene therapy expertise
- BS, MS or PhD (chemical engineering, bioengineering, biology, biochemistry, virology or related field) with 7+ years’ experience, 4+ years’ experience or 1+ years’ experience in biologics process development of large molecule or cellular therapies
- Knowledge and experience with media development, fed-batch, perfusion, etc. cell culture methodologies
- Knowledge and working experience with cell culture process development in mammalian cells, process scale-up, bioreactor design and optimization, and transient transfection
- Knowledge and experience with process characterization and tech transfer is essential
- Knowledge and experience with Ambr® systems
- Knowledge of viral gene therapy (AAV vectors preferred); background in protein and/or viral vector engineering
- Understanding and knowledge of regulatory requirements for biologic products
- Strong organizational, analytical and problem-solving skills
- Demonstrated ability to present ideas, information and data effectively via one on one discussions, team meetings and collaborative interactions
- Responsible for maintaining up-to-date knowledge of regulatory requirements and quality standards related to area of development
- Ability to work both independently and in a fast-paced, team-oriented setting
- Excellent written and verbal communication, work planning, data analysis and record keeping skills (with strong attention to detail) is required
More about you
Hands-on knowledge of DOE, JMP, FlowJo and GraphPad statistical software for use in design of technology development studies is highly desirable.
Experience in regulatory IND filing and working knowledge of US/EU CLD requirements is highly desirable.
We offer a competitive total rewards package. Are you our next great discovery?