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.
As the Sr. Manager/Associate Director of QC Microbiology, you will be responsible for development and implementation of microbiological programs to support REGENXBIO's new internal Manufacturing facility as well as supporting the current portfolio of clinical programs. Main responsibilities will include establishment of Environmental Monitoring and Utility Monitoring Programs, establishment of microbiological test methods for Gene Therapy products and raw materials, aseptic support for our future fill operations and will serve as a key SME for the Contamination Control Program.
What you'll be doing
- Lead the development, implementation, and oversight of microbiological testing programs for all stages of clinical and commercial manufacturing operations including endotoxin, bioburden, sterility testing, microbial ID testing, raw materials, water, and environmental monitoring.
- Support the development of Quality Control quality systems and SOPs for QC Microbiology programs.
- Generate training materials/content and provide training for applicable personnel on microbiological best practices, principles and techniques.
- Provide SME support for QC deviations and investigations, working with internal and external testing laboratories and manufacturing organization on investigation actions, root cause analysis and product impact assessments.
- Support the hiring and development of QC Microbiology staff
- Serve as and SME during internal and external audits and regulatory inspections.
- Demonstrated ability to lead in a collaborative environment with a positive leadership style and hands-on approach that emphasize teamwork and consensus.
- Ability to manage large projects and implement microbiology programs.
- 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.
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 10+ years industry experience and 5+ years in a leadership role
- Extensive experience in developing and managing environmental monitoring programs and safety release testing of drug products.
- Strong understanding of applicable USP, ICH, 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.
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.