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QC Analyst III / Sr. QC Analyst - Molecular at REGENXBIO

QC Analyst III / Sr. QC Analyst - Molecular

REGENXBIO Rockville, MD Full-Time
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 Quality Control Analyst III - or Sr. Quality Control Analyst - Molecular, you will be responsible for supporting the manufacture of AAV Viral Vector Gene Therapy Drug Products through the performance of Analytical/Bioanalytical testing of starting materials, in-process/finished drug product and stability samples.

What you’ll be doing

  • Performs Analytical/Bioanalytical testing of starting materials, in-process/finished drug product and stability samples, potentially utilizing: cell-based assays, qPCR/ddPCR, HPLC (size exclusion, reversed-phase, ion-exchange), capillary electrophoresis, light scattering, spectrophotometry, and product and residual content assays.

  • Performs product characterization assays to support product development and PPQ campaigns.

  • Works closely with Analytical Development to support on the qualification, validation, and/or transfer of methods to the QC laboratories.

  • Support instrument installation and qualification activities and monitor lab equipment for instrumentation issues or calibration needs.

  • Provides input/authorship of document revisions related to SOPs and WIs.

  • Troubleshoot and resolve analytical method and instrument issues to successful resolution, independently.

  • Serve as primary author for Laboratory Investigations, OOS/OOT results, Deviations, CAPA, and Change Controls.

  • Participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments.

  • Performs data interpretation, statistical analysis, trending, and data review as assigned.

  • Provides training, advice, and technical guidance to junior staff acting as technical resource (SME) for Molecular based assays.

  • Maintain Analytical laboratories in a state of inspection readiness and compliance.

  • Cross-train to serve as backup in Quality Control sample receipt and Contract Testing Lab management functions.

  • Implement and maintain inventory of critical assay reagents and consumables.

  • Flexibility in following unique manufacturing campaign testing requirements that may include off-hour and weekend work.

  • Other duties as assigned.

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:

  • B.S. or A.S. in a Life Sciences discipline preferred with at least 4-6 years of relevant experience working in a cGMP environment.

  • Experience working in cGMP Quality Control, preferably in a Biologics or CGT setting.

  • Solid scientific knowledge and hands on lab experience in molecular biology and other analytical methods.

  • Ability to independently plan or perform experiments for assay development, product release/stability/characterization, support for project activities with minimal supervision.

  • Understanding of Good Manufacturing Practices (cGMPs).

  • Strong attention to detail and strong organizational skills.

  • Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational as well as routine quality tasks.

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 the be exposed to challenging projects and development resources to help you grow personally and professionally.

Recommended Skills

  • Analytical
  • Attention To Detail
  • Biopharmaceuticals
  • Calibration
  • Certified Global Meeting Planner
  • Change Control
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