Position Summary This strategic role leads independent initiatives to optimize DNA manufacturability, quality, and scalable production. The successful candidate will be accountable for the rational design and technical review of DNA constructs that serve as critical starting material for rAAV manufacturing. This role drives process understanding by linking DNA design to process performance and vector quality while generating summary technical documentation and fostering a collaborative culture of scientific excellence.
This position is based on-site in Research Triangle Park (RTP), North Carolina, and reports to the Process Development Associate Director/Director.
Job Responsibilities- Independently design and execute project initiatives to improve DNA manufacturability and quality with good judgement against defined timelines
- Rationally design and test DNA constructs to increase DNA and rAAV manufacturing productivity and/or improved DNA and vector quality
- Provide subject matter expertise on development of new and/or improved methodologies for DNA production that is fit for purpose (scale, yield etc)
- Lead AskBio CMDO collaborations to improve DNA manufacturing and transfer of relevant processes
- Serve as a technical consultant on DNA starting materials used for Chemistry, Manufacturing and Control (CMC) activities and regulatory strategis, when applicable
- Lead investigations and troubleshooting of DNA purification and analytical characterization as needed
- Represent the DNA Development function in project teams and present data at internal and external forums
- Author technical and development documents, including relevant regulatory submission sections
- Excellent team player who develops and encourages a team environment within the company's mission and values
- Mentors and develops team members by establishing a collaborative and growth minded culture that encourages personal and professional development
- Perform hands-on experiments, when necessary, while maintaining and promoting a clean, efficient, and safe laboratory environment
Minimum Requirements - PhD (Molecular Biology, Genetics, Virology or equivalent) with 5+ years of relevant work experience including post-doc experience; or MS (Molecular Biology, Genetics, Virology or equivalent) with 10+ years of relevant work experience
- Expertise in viral gene therapy, including recombinant adeno-associated virus systems
- Strong, comprehensive understanding of the molecular attributes that influence both DNA replication in bacteria and rAAV production in mammalian culture
- Demonstrates self-motivation, strong orginzational acumen, and independent strategic thinking with the versatility to perform effectively in both autonomous and collaborative settings
- Excellent written and verbal communication, work planning, data analysis and record keeping skills
- Good working knowledge of Microsoft Office suite (Word, Outlook, Excel) and SnapGene
Preferred Education, Experience and Skills- In-depth knowledge of bacterial cell culture (E. coli preferred), establishing bacterial glycerol stocks, DNA purification by commercially relevant methods, and molecular biology techniques such as cloning, PCR, DNA quantification, restriction enzyme digest and Sanger and/or NextGen Sequencing
- Demonstrated technical proficiency with fermenters/bioreactors, AKTA liquid chromatography systems, and tangential flow filtration
- Competnecy with electronic laboratory notebooks
- Applied understanding of rAAV manufacturing
