Ultragenyx Pharmaceutical
Senior Quality Control Analyst I, Bioassay
Woburn, MA · Senior
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About the role
- ultra innovative - Tackle rare and dynamic challenges
- In addition, the Senior QC Analyst I will review, enter and approve analytical data generated internally and from external laboratories.
- This role typically requires that the majority of the work be conducted on-site.
Responsibilities
- Performs routine QC testing in a GMP environment to support product release and stability including but not limited to
- Executes sample management in support of GMP manufacturing including, but not limited to, incoming sample receipt, sample aliquoting, sample transactions in LIMS, sample distribution to testing laboratories and sample disposal.
- Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells, qualify critical reagents, etc).
- Author and support quality events
- Support method transfer and validation activities for development, technical transfer, and validation of late-stage assays for AAV-based gene therapy programs.
Requirements
- BS in Cell Biology, Molecular Biology, Biochemistry or a related discipline with minimum 6-8+ years industry experience or MS with 4-6 years' experience.
- 4+ 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
Nice to have
- Experience with statistical analysis (SoftMax, JMP) and LIMS (LabVantage) preferred
Company info
- 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.
This listing is sourced directly from Ultragenyx Pharmaceutical's careers page and normalized into a canonical job model.