Sr Scientist – DNA Manufacturing/Process Development Group Lead
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 SENIOR SCIENTIST- DNA MANUFACTURING/PROCESS DEVELOPMENT GROUP LEAD to join the AskBio team!
About the Role
This position provides the planning and execution of DNA manufacturing in addition to experiments designed to optimize DNA production, purification and scalability. This role requires working knowledge of microbiology, molecular biology, biochemistry and related chemistries, preferably in chromatography, centrifugation and filtration design principles along with fermentation and DNA manufacturing.
Responsibilities and Accountabilities
- Ability to lead a group of scientists while being hands-on at the bench
- Oversee day-to-day activities of the DNA development/manufacturing team including planning, mentoring, and providing direction, when required, to improve all functions of the lab
- Knowledgeable of current and new technologies with a priority of implementing the use of new technologies
- Develop robust, efficient, scalable fermentation and downstream purification strategies for improving DNA manufacturing process performance in collaboration with fellow scientists and collaborators
- Communicate and collaborate across functional areas such as upstream process development, analytical development, manufacturing, R&D, project management and regulatory
- Conduct experiments and analyses as part of a variety of research and development activities, e.g., small-scale studies, scale up studies, technology transfer and process development
- Evaluate and summarize the experimental results, develop and test hypotheses to improve understanding of DNA manufacturing strategies, yield, purity and recovery
- Support technology transfer internally and externally, manufacturing and quality by design
- Prepare internally reviewed technical reports, CMC documents, manuscripts and internal and external oral presentations
- Experimental design and establishment of project timelines
- Support higher management in the establishment and tracking of yearly budgets
- MS or PhD degree in a biological or engineering discipline (microbiology, molecular biology, biotechnology, chemistry/biochemistry, chemical/biochemical engineering, or equivalent)
- Experience in laboratory research and a desire to continue in a laboratory-focused role while managing a group of scientists
- Minimum 8-12 years of experience in laboratory research required, preferably in DNA manufacturing and development, bioprocess manufacturing and technology transfer
- Experience with analytics and bioprocess technology is required
- Experience with fermentation, filtration and chromatography
- Familiarity with GLP and cGMP
- Demonstrated ability to generate results and innovative solutions with minimum supervision
- Applicants should be self-motivated, organized, capable of working independently as well as in a group environment to collaborate with manufacturing staff on experimental studies
- Applicant must have experience with team building, as well as motivational and project management skills
- Experience with upstream and downstream process development
- The successful candidate will possess strong oral and written communication skills
- Good judgment and innovation to achieve a solution within standard practices and procedures
- Strong analytical and computer skills are required
- Sound understanding of statistical experimental design and analysis such as design of experiments is a plus
- Knowledge of Microsoft Office suite (Word, Outlook, Excel) required; experience with JMP a plus
- Experience with global teams, especially Spanish speaking, a plus
Live an AskLife™
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