Associate Scientist/Senior Associate Scientist, Downstream Process Development
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).
Req Number: MAN-18-00011
Reporting to the Scientist/Sr. Scientist of Downstream Process Development, the Associate Scientist (or Senior Associate Scientist) is responsible for: (1) the development, optimization, and scale-up of GMP compliant downstream process for recombinant Viral Vectors. (2) The development and execution of quick AAV purification method to support Upstream development and Research. (3) Designing and performing scale-down process steps to support and trouble-shoot manufacturing. (4) Process Scale-up/Tech Transfer to GMP manufacturing. This position requires hands-on execution of product recovery, clarification, purification and formulation process development. The successful candidate is expected to work independently on assigned tasks/projects and prioritize assignments.
- Develops scalable downstream processes for product recovery, clarification, purification and formulation of AAV vectors.
- Develops and executes rapid AAV purification methods to support Upstream development and Research.
- Designs and performs scale-down process steps.
- Works on process scale-up and Tech Transfer to GMP manufacturing.
- Performs hands-on experiments using AKTA series of chromatography skids and current filtration technologies (Normal Flow Filtration and Tangential Flow Filtration)
- Performs standard analytical methods to characterize biologics, including HPLC, SDS-PAGE, Western Blot, spectrophotometer
- Designs experiments, analyzes results and uses results for improvement of processes
- Compiles raw data for presentation or Tech Report using Microsoft Office products
- Ensures proper documentation and reporting of experiments and results
- Authors Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission
- Supports the execution of start-up and commissioning of equipment and processes
- Collaborates with upstream and assay development groups to coordinate material needs
- Reviews batch records during tech transfer and cGMP manufacturing
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
- BS or MS in biochemistry, chemistry, chemical engineering or biological sciences
- Minimum 5+ years (for BS) or 3+ years (for MS) downstream process development experience in using chromatography and filtration based purification methods
- Familiar with AKTA purification skids and Tangential Flow Filtration (TFF) operations
- Experience with analytical methods used for downstream process development
- Task- and team-oriented, analytical, organized, detail-oriented, self-motivated and demonstrates ability to multitask.
- Excellent record keeping abilities to adequately document process development data
- Strong verbal and written communication skills and ability to communicate within the organization as well as externally
- Intermediate computer skills using MS Office (Word, Excel, Power point)
- Familiar with process characterization using Design of Experience (DoE), Quality by Design (QbD) preferred
- Familiarity with FDA guidance and quality systems preferred
- Experience in a cGMP environment preferred
- Familiarity with TECAN liquid handler is a plus
- Experience with Viral Clearance is a plus
- Processes: Buffer preparation, Depth filtration, Clarification, Tangential Flow Filtration (TFF), Chromatography, AKTA series instrument, Viral filtration
- In-process analysis: HPLC, SDS-PAGE, Western Blot, BCA assay, UV spectroscopy
- }cGMP documentation
- Design of Experiment (DoE by JMP software)
- Microsoft Word, Microsoft Excel, Microsoft PowerPoint, DLIMS, AKTA Unicorn 5.3, 6
- Viral clearance studies
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
- Must be able to lift up to 25 lbs with or without reasonable accommodations.
- Lab work will be conducted in a biosafety level 2 laboratory.
To be determined
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.