Associate Scientist III, Formulation and Drug Product Development

Who we are
REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.
The opportunity
You will be a part of a team responsible for development of stable formulations, drug delivery systems, and manufacturing processes for recombinant adeno-associated virus (AAV) gene delivery products. You will contribute to formulation development, characterization, and stability studies; design of drug product presentations; process development; clinical compatibility studies; and aseptic fills for GLP studies for multiple projects. You will work both independently and as a part of cross-functional teams on assigned projects, prioritize projects to meet departmental and organizational goals, and communicate results in technical reports and presentations. What youll be doing

• Contribute to individual formulation development, characterization, compatibility, and stability studies
• Contribute towards individual drug product process design, characterization studies, and aseptic fills for GLP studies
• Document executed studies in a lab notebook and summarize study outcomes in technical reports and presentations.
• Contribute to pertinent regulatory submission sections including INDs, BLAs, and equivalent
• Perform relevant methods and techniques in support of pharmaceutical development goals
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
• This role requires travel up to 10% of the time

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

• Bachelors degree in relevant scientific discipline with at least 5+ years relevant industry experience or Masters degree in relevant scientific discipline with 3+ year of relevant industry experience
• Familiarity with theoretical and practical knowledge of formulation development and characterization principles
• Ideally has an understanding of aseptic fill-finish of biologics, including unit operations, GMP requirements, media simulations, container/closure integrity, and regulatory requirements
• Ideally has an understanding of bioanalytical techniques for product characterization and product stability evaluation, including dynamic light scattering, spectrophotometry, subvisible particle analysis, and HPLC
• Familiarity with pertinent regulatory submission sections including INDs, BLAs, and equivalent
• Able to locate relevant scientific literature and standard industry guidance documents
• Ability to perform routine data analysis
• Ability to independently plan and perform experiments that support scientific activities and project goals
• Ability to interpret data, draw conclusions, and recommend next steps
• Must be able to demonstrate judgment in selecting methods and techniques for obtaining results
• Ability to effectively communicate information and results in the appropriate format (i.e. lab notebooks, presentations, etc.)
• Must be able to work collaboratively and effectively as part of a team
• Prior industry experience preferred

Why You Should Apply By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients. In addition, professional development is important to us. By joining our team, youll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally. We are proud to offer a comprehensive rewards package which includes a market-competitive base salary, an annual performance-based bonus program, stock grants at all levels, and benefits such as health, dental, and vision insurance, retirement plan with 401(k) match, summer hours, and more! The estimated compensation range for this role is $91,000 to $124,000 annually. The actual salary offered to the final candidate depends on a number of factors such as relevant work experience, skills, education, and years of experience.