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

REGENXBIO is seeking a highly motivated Upstream Manufacturing contractor to establish REGENXBIO’s 1 internal GMP BDS and FDP clinical and commercial AAV gene therapy manufacturing capability. As a member of the highly engaged and collaborative Manufacturing Operations team, you will have the unique opportunity to start-up an agile, multi-product, single-use facility. The contractor, under direct supervision, will be accountable for supporting the establishment of new processes, procedures and ways of working, as well as performing manufacturing process related tasks and unit operations within the Upstream, Downstream, and/or Fill Finish areas.

What You'll Be Doing

• Opportunity to work in an “ALL”stream environment that allows for cross-functional development between the differing manufacturing areas, i.e. media/buffer prep, upstream (US), downstream (DS), and fill finish (FF).
• Embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
• Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
• Partner with Quality to maintain a robust quality and compliance culture and performance that meets applicable GMP regulatory standards and supports regulatory inspections.
• Follows standard practices and procedures to perform and verify process tasks and unit operations.
• Execute and support operational readiness activities for the NEW internal manufacturing facility, including the establishment of manufacturing procedures and standard practices, facility start-up, commissioning, and qualification of equipment and automation.
• Proactively work to achieve training competency in an expanding manufacturing facility.
• Applies company policies and procedures to identify, escalate and/or resolve routine production issues.

• Bachelor’s degree OR Associate’s degree/High School Diploma OR equivalent with relevant cGMP experience.
• 0-2 years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
• Ability to work collaboratively with colleagues in a results-driven, team-oriented environment.

• Preferred Qualifications
• Good oral and written communication skills.
• Good teaching and facilitation skills for on-the-job training delivery.
• Experience in GMP quality systems and/or manufacturing operations, processes and equipment for US, DS, and/or FF areas.
• Experience with AAV manufacturing/viral transfection.
• Experience in supporting facility start-up, commissioning, and qualification activities.
• Hands on experience with single-use technologies and systems.
• Experience using PCS system.
• Demonstration of a high level of performance.