Senior Quality Control Analyst II, Bioassay

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:

ultrafocused – Work together to fearlessly uncover new possibilities

This position is in the Ultragenyx Gene Therapy Quality Control Bioassay group. The Senior QC Analyst II will work with others in Quality Control and Analytical Development in a dynamic environment to support AAV-based gene therapy programs.  The Senior QC Analyst II will perform cell-based bioassays, ELISAs, and other biological methods in a GMP setting. In addition, the Senior QC Analyst will review, enter and approve data from external laboratories. Routine work includes release and stability testing, critical reagent qualification, method validation and transfer, critical reagent qualification, analyzing data, and authoring technical documents.

Work Model:

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

 

Responsibilities:

• Performing routine QC testing including, but not limited to, quantitative PCR and cell-based assays in a GMP environment to support product release and stability.
• Review and approval of cGMP analytical data for release and stability testing from bioassay test methods including, but not limited to, mRNA expression, functional potency and ELISA testing platforms.
• Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
• 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.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).
• Model leadership behaviors and mentor/train junior staff
• Work with cross functional teams with both internal and external stakeholders

Requirements:

• BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 5+ years industry experience
• Experience in a GMP/GLP environment is a must.
• Experience in routine mammalian cell culture required
• Experience with quantitative PCR required. Experience with cell-based potency assays is required. Experience performing immunoassays such as ELISAs strongly desired
• Experience with statistical analysis (SoftMax, JMP) preferred
• Ability and desire to work in a fast-paced environment
• Strong collaboration, team-working skills, and communication skills
• Independently motivated and detail-oriented with good problem-solving ability
• Strong communication, interpersonal and organizational skills

Physical Demand Requirements:

• 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-CS1 #LI-Onsite