QC Microbiology, Senior Analyst II

Why Join Us?   Be a hero for our rare disease patients   At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.    Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work.   If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities

Reporting to the QC Microbiology Director, the Senior QC Analyst II will support the Ultragenyx gene therapy program pipeline through oversight, review and/or execution of GMP microbiological assays including but not limited to endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing.  This position is responsible for scheduling laboratory activities and ensuring testing is completed on time and in a compliant manner. 

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

1. SME for multiple microbiological assays (e.g. bioburden, endotoxin, TOC, conductivity, growth promotion, etc.). 
2. Execute routine, non-routine, and qualification testing of in-house microbiological methods. 
3. Review and approve cGMP analytical data from utility, release, and stability testing for internally and externally generated data. 
4. Support and lead QC Microbiology laboratory operations (e.g. monitor incoming samples, schedule microbial testing and qualification of critical media and reagents, ensure QC data packets and logbooks are reviewed within required timelines, etc.). 
5. Independently own and author quality records including change controls, deviations, CAPAs, invalid assays, excursion investigations, OOS Investigations, etc. with minimal managerial oversite. 
6. Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).  
7. Serve as trainer for in-house microbiological methods. 
8. Lead, or participate in, the development of new methods.  
9. Model leadership behaviors and mentor/train junior staff.   
10. Work with internal/external personnel within and outside area of expertise to support cross functional activities. 
11. Participate in regulatory inspections. 

Requirements:

1. BS or MS in Microbiology with 6+ years of QC experience. 
2. Demonstrated knowledge of microbiological methods including endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing. 
3. Strong technical writing skills with demonstrated experience in controlled document generation in