Senior Associate Scientist, Upstream Operations Vector Core
About the Organization
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.
Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. Our lead product candidates are RGX-314 for the treatment of wet age-related macular degeneration (wet AMD), RGX-501 for the treatment of homozygous familial hypercholesterolemia (HoFH), RGX-111 for the treatment of Mucopolysaccharidosis Type I (MPS I) and RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II).
Reporting to the Director of Vector Core, the Senior Associate Scientist is responsible for the production of non-GMP recombinant Viral Vectors for internal groups as well as external collaborators. Responsibilities include the scale up and maintenance of small and medium scale adherent and suspension cultures, application of gene transfer technologies and harvest of recombinant AAV as well as other viral vectors. This position requires the ability to handle multiple projects, good writing skills as well as excellent documentation practices. The successful candidate is expected to work independently on assigned tasks/projects and prioritize assignments.
- Performs small and medium scale production of AAV and other viral vector systems for internal groups as well as external collaborators.
- Maintains adherent and suspension cell cultures at small and medium scales, including shaker flasks, WAVE bioreactors and stir tank bioreactors.
- Applies gene transfer technologies, including transfection and infection, to generate recombinant viral vectors.
- Harvests generated viral vectors for further processing.
- Coordinates with downstream team timely execution of assignments.
- Transfers newly developed procedures and ensures proper documentation and execution.
- Develops, drafts and applies Standard Operation Procedures, protocols, as well as Batch Records.
- Ensures proper documentation and reporting of experiments and results.
- Supports the commissioning and maintenance of equipment.
- Manages, and trains junior associates on procedures and processes in the lab.
- Coordinates with team members assigned projects and equipment usage.
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
- BS or MS in biochemistry, chemistry, chemical engineering or biological sciences
- Minimum 9 years (for BS) or 7 years (for MS) experience in mammalian upstream processes.
- Experience with adherent cell culture systems as well as suspension systems using shaker flasks as well as bioreactor systems.
- Familiar with cell harvest operations.
- Task & team-oriented, organized, detail-oriented, self-motivated and able to multitask.
- Excellent record keeping abilities to adequately document process data
- Possess excellent interpersonal skills, both oral communication and written. Must be able to communicate effectively with all echelons of management and staff.
- Intermediate computer skills using MS Office (Word, Excel, PowerPoint)
- Familiarity with FDA guidance on quality systems preferred
- Experience in a cGMP environment preferred
- Experience with viral vector systems preferred
- Statistical/DOE experience preferred
- Mammalian and/or insect cell culture using adherent and/or suspension cell units.
- Gene transfer technologies using DNA and/or viral vectors.
- Cell harvest technologies.
- Intermediate computer skills using MS Office (Word, Excel, Power point)
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
- Follow rules of Biological Safety Level 2 laboratories.
- Must be able to lift to 25 lbs with or without reasonable accommodations.
Maryland - 9714
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.