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:

This position is in the Ultragenyx Gene Therapy Quality Control Molecular Biology group. The QC Analyst II will work with others in Quality Control in a dynamic environment to support AAV-based gene therapy programs. The QC Analyst II will perform analytical methods including but not limited to analytical methods such as GC titer determination by ddPCR and dPCR, impurity testing, and other methods as needed in a GMP setting. Routine work includes in-process, release and stability testing, critical reagent qualification, method validation and transfer, instrument and lab maintenance, analyzing data, and authoring technical documents.
ultraimpact – Make a difference for those who need it most

REQUIREMENTS:

• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must
• BS/MS Molecular Biology, Cell Biology, Biochemistry, or a related discipline with at 2+ years of experience working in a cGMP environment
• Hands-on experience with performing dPCR, ddPCR and/or qPCR test method execution required
• Strong collaboration and team-working skills
• Strong communication, interpersonal and organizational skills
• Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
• Should be highly motivated, demonstrate good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities

Physical Demand Requirements | Lab:

• Stand for extended periods of time with periodic stooping / bending / kneeling
• Able to lift, push, pull up to 50lbs
• Climb ladders and stairs of various heights
• Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment
• Certain tasks may require use of a respirator; medical clearance will be required in advance

LI-AJ1 #LI-Hybrid

• Performs routine QC testing including but not limited to: ddPCR/dPCR and qPCR test methods in support of in-process, release, and stability
• Review and approval of cGMP analytical data for in-process, release and stability testing from internal and external analytical test methods
• Supports QC Molecular Biology laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualification of critical reagents and assay controls, etc)
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods
• Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs
• Author analytical method performance trend reports, as needed
• Work with cross functional teams with both internal and external stakeholders
• The job responsibilities may change as needed to support activities relevant to the clinical phase