Ultragenyx Pharmaceutical

Senior Quality Control Analyst I, Bioassay

Woburn, MA · Senior

Sponsorship not specifiedDetected 21 days ago

StatisticsGMPPCRqPCRCRISPRMolecular BiologyCell CultureProtein AnalysisLeadershipCommunicationCollaborationProblem SolvingOrganizational Skills

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

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.

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

Experience with statistical analysis (SoftMax, JMP) and LIMS (LabVantage) preferred

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 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.

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.