Produce research-grade AAV vectors using the HEK293 system and density gradient-based purification, use of cell stacks, cell factories, small bioreactors
Enable execution of discovery and pre-clinical activities through the production of research grade AAV vectors.
Support development of robust, well-characterized, high quality and high yielding downstream production processes for AAV gene therapy products across internal programs.
Contribute to the design and execution studies to develop a thorough understanding of the process design space, with a view towards scale-up and successful regulatory filings.
AAV Tactical responsibilities
Clone highly complex library assemblies for AAV production
Execute large scale DNA preparation protocols for transfection
Implement next-gen sequencing DNA preparation procedures
Set up and manage helper plasmids and AAV vectors inventories
Co-ordinate production needs with different teams and manage supply chain
Proactively communicate risks to delivery to management
Help establish and implement protocols, SOPs and systems within the developing team
Maintain electronic lab notebooks and communicate results to stakeholders
Maintain requests dashboard and database
Maintain production cell lines and their inventory
Oversee and mentor laboratory technicians and interns in proper laboratory techniques and scientific experimental design
Manufacturability group standard responsibilities
Interact with peers across the organization including in the US
Communicate key finding to internal and external stakeholders
Assess the manufacturability of a client’s modality in conjunction with the rest of the manufacturability team
Engage collaboratively with the client to understand and improve the manufacturability of therapeutic modalities
Author and follow standard operating procedures, batch records, and other process documentation
Filing of invention disclosures and basic understanding of intellectual property with the assistance of relevant internal and external parties/stakeholders
Drive innovation through the design and troubleshooting of experiments for testing various unit operations in process development in accordance with clients need and company’s overall strategic goals
Requirements
PhD in molecular biology, virology, synthetic biology or equivalent with 1-3 years of laboratory research experience
1-5 years of work experience with various AAV systems
Good understanding of AAV analytics (ddPCR, ELISA, CE-SDS, AUC) in support of product characterization
Innovative and analytical thinker with outstanding interpersonal, communication, and leadership skill
Demonstrated ability to clearly communicate technical information and roadmaps through written protocols and/or presentations containing clean figures and visualizations