QC Supervisor

The opportunity
As the Supervisor, QC - Analytical, you will be responsible for supporting the manufacture of AAV Viral Vector Gene Therapy Drug Products through ensuring the performance of Analytical/Bioanalytical testing of starting materials, in-process/finished drug product and stability samples. This role will also be responsible for technical writing such as authoring/editing procedures and investigations as well as the technical lead for ensuring the use of qualified and validated methods in the GMP laboratories. In addition, daily scheduling of staff members and management of analysts in the laboratory is required.

What you’ll be doing

• Oversees the daily activities and manages the performance of QC Analysts supporting two of the four QC Analytical functions: Chemistry, Potency, Molecular, and Sample Management.
• Ensures the proper Analytical/Bioanalytical testing of starting materials, in-process, bulk drug substance, final drug product, and stability samples in techniques utilizing: cell-based assays, qPCR/ddPCR, HPLC (size exclusion, reversed-phase, ion-exchange), capillary gel electrophoresis, light scattering, spectrophotometry, and/or compendial assays.
• Maintains the inventory of qualified reference standards, critical reagents, lab consumables, and/or cell lines.
• Confirms tracking of incoming and outgoing samples in the sample lifecycle.
• Follows up on external testing at contract testing laboratories.
• Works closely with Analytical Development to support 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, WIs, Specifications, and/or Certificates of Analysis.
• Serve as primary author or reviewer for Laboratory Investigations, OOS/OOT results, Deviations, CAPA, and Change Controls originated internally as well as with vendor sites.
• Participate in cross functional teams for Operation Excellence, Root Cause analysis, and risk assessments.
• Interfaces with CMC and Regulatory leads to provide Analytical information in necessary documents.
• Troubleshoot and resolve analytical method and instrument issues to successful resolution, independently.
• Performs data interpretation, statistical analysis, trending, and data review.
• Provides training, advice, and technical guidance to QC staff acting as technical resource (SME) for disciplines selected to oversee.
• Maintain Analytical laboratories in a state of inspection readiness and compliance.
• Flexibility in following unique manufacturing campaign testing requirements that may include off-hour oversight.
• 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:

• 1-2 years of Team Lead or Supervisory experience is strongly preferred.

• B.S. or M.S. in a Life Sciences discipline preferred with at least 6 years of relevant experience working in a commercial cGMP environment is highly desired.
• Experience working in cGMP Quality Control, preferably in a Biologics or CGT setting.
• Solid scientific knowledge and hands on lab experience in cell-based assays, biochemistry techniques, and/or other analytical methods.
• Equipment, vendor management, and/or contract testing lab management.
• Use or design of electronic laboratory notebooks strongly preferred.
• Understanding of cGMPs and the applicable USP, ICH, FDA, and Ph Eur requirements related to QC testing.
• Strong attention to detail, organization, and effective communication skills cross-functionally.
• Have the knowledge and ability to apply 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.