Gene Therapy Production Lead (Downstream - Manufacturing Operations)
 Rockville, MD

Requisition Number: GENET01479

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

As the Gene Therapy Production Lead, you will play a critical role in helping to establish REGENXBIO’s first 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. You 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 Upstream as well as Downstream and Fill/Finish operations.

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.
  • 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 GTPS employees 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.

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:

  • 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.

Preferred Qualifications

  • Strong subject matter expertise in GMP Manufacturing operations, processes and equipment for US, DS, and/or FF areas.
  • Experience in aseptic fill finish and 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 DeltaV PCS system.

Why should you 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.

We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

In addition, professional development is important to us. By joining our team, you’ll have the opportunity to be exposed to challenging projects and development resources to help you grow personally and professionally.