Gene Therapy Manufacturing Lead

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.

We are seeking a highly motivated Gene Therapy Manufacturing (GTM) Lead 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 Value Stream team, you will have the unique opportunity to start‑up an agile, multi‑product, single‑use facility. The GTM Lead will play an important role in leading 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.

• 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.
• 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.
• Serve a lead role in process tech transfers and batch record establishment.
• Coordinate daily operations and lead GTM personnel to complete production activities safely and compliantly, in accordance with OSHA and cGMP guidelines.
• Proactively work to achieve training competency in an expanding manufacturing facility.
• Perform as a subject matter expert (SME) and qualified trainer for most GMP manufacturing operations, processes and equipment for US, DS, and/or FF areas.
• Lead root cause analysis for manufacturing events of varying complexity.
• Lead projects of minor to moderate scope with the support of cross‑functional stakeholders.
• Travel up to 5% or less of the time is required.
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

• Bachelor’s degree OR Associate’s degree/High School Diploma or equivalent with relevant cGMP experience.
• 6+ years cGMP experience in biologics, pharmaceutical and/or vaccine manufacturing operations, including experience in cell culture, recovery, purification, bulk formulation and/or fill finish.
• Excellent oral and written communication skills with strong technical writing ability required.
• Excellent teaching and facilitation skills for on‑the‑job training delivery.
• Expert in authoring, revising and/or reviewing GMP documentation (i.e. SOPs, Batch Records, etc.).
• Strong organizational and leadership skills.
• Strong experience in GMP quality systems, including deviation root cause analysis tools.
• Ability to apply continuous improvement and operational excellence strategies within a manufacturing organization.
• Ability to think critically in regard to problem solving and troubleshooting.
• Ability to work collaboratively with colleagues in a results‑driven, team‑oriented environment.
• Strong subject matter expertise in GMP Manufacturing operations, processes and equipment for US, DS, and/or FF…