Sr. QC Analyst - Microbiology

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 Sr. Quality Control Analyst -- Microbiology, you will be responsible for working both independently and with the team, to perform microbiological testing (bioburden, endotoxin, growth promotion, microbial identification, etc.) for raw material, in-process, and release product samples to ensure patient safety. This role will also be responsible for technical writing such as authoring/editing procedures and investigations as well as the technical lead for non-routine testing and qualification activities in the laboratory.

What you'll be doing:

• Performs routine and non-routine microbiological assays to support raw material, in-process, and release testing for novel Gene Therapy products
• Performs routine and non-routine microbiological sampling and testing activities to support the Environmental and Clean Utility Monitoring programs
• Assists in the development of strategies/projects to implement industry best practices for microbiology laboratories
• Generation of data reports and/or trends in support of the Environmental and Clean Utility Monitoring programs
• Authors/Revises SOPs and WIs, to maintain compliance to industry standards/regulations or for enhanced clarity and accuracy
• Authors and reviews assay qualification protocols, reports, CAPAs, Deviations and Laboratory Investigations
• Attends cross-functional meetings as a QC Microbiology representative
• Support the development of entry to mid-level QC Microbiology staff
• Strong collaboration, team-working skills and communication skills
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.
• Position is primarily 1st shift however successful candidates must have flexibility to cover other hours/shifts as needed to support laboratory functions and manufacturing operations
• This position may involve indirect oversight of entry to mid-level QC associates to provide training, advice and guidance to aid in the development of personnel or to troubleshoot assay issues in the laboratory.

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:

• Degree from four-year college or university in Microbiology or a related discipline with 8+ years industry experience in a GMP environment.
• Experience in environmental monitoring programs and safety release testing of drug products.
• Understanding of applicable USP, ICH, FDA and Ph Eur regulations related to QC testing.
• Experience in assessment of manufacturing processes and facilities for microbial risk
• Independently motivated and detail-oriented with good problem-solving ability.

Working Conditions and Safety

• Employees must adhere to all federal and/or local regulations, laboratory health and safety procedures, and all company Standard Operating Procedures, policies, and guidelines.
• Lab work will be conducted with some exposure to chemicals in a biosafety level 1 laboratory requiring personal protective equipment.

Essential Physical Requirements

• Must be able to lift and move up to 25 lbs with or without reasonable accommodations.
• Must be able to perform clean room gowning to support on the floor investigations and other activities.
• Must be able to work in a shared lab/office space environment.

Why should you apply?

By joining REGENXBIO, you will have the opportunity to be a part of a growing company, with an incredible team, who is passionate about developing novel AAV gene therapies for patients in need.

We offer a comprehensive and competitive benefit & compensation package 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 have access to development resources to help you grow personally and professionally.