This position is in the Ultragenyx Gene Therapy Quality Control Bioassay group. The Sr QC Analyst I will work with others in Quality Control and Analytical Development in a dynamic environment to support AAV-based gene therapy programs. The Sr QC Analyst I will perform cell-based bioassays, ELISAs, and other biological methods in a GMP setting. In addition, the Sr QC Analyst I will support testing at 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.
ultrafocused – Work together to fearlessly uncover new possibilities
Work Model:Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:- Provide hands-on leadership and subject matter expertise by performing 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
- Author SOPs and technical documents
- Support the development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs
- Work independently to review and trend QC data
- Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
- Train and mentor junior staff
- Maintain the QC Bioassay laboratory (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc)
- Work with cross functional teams with both internal and external stakeholders
- 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
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
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Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Ultragenyx Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Ultragenyx and has not been reviewed or approved by Ultragenyx.
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Healthcare Strength — Benefits begin on the first day with multiple medical plan options alongside dental and vision coverage. Employer-funded HSA contributions and employer-paid mental health support via Spring Health add notable depth to healthcare support.
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Leave & Time Off Breadth — Paid time off is broadened by two fully paid company shutdown weeks in August and December in addition to holidays and baseline vacation. Paid sick time, paid volunteer time, and a substantial paid leave program further expand time-off support.
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Retirement Support — Retirement support includes a 401(k) program with a match on employee contributions and immediate vesting. An employee stock purchase plan discount also strengthens the overall financial rewards package.
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What We Do
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.
