Senior Analyst I – QC Bioassay
| Company | Ultragenyx Pharmaceutical |
|---|---|
| Location | Burlington, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
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
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
Preferred Qualifications
- Experience with statistical analysis (SoftMax, JMP) preferred