Senior Analyst I, QC Bioassay
Senior Analyst I, QC Bioassay
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Summary:
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
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
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
#LI-CT1 #LI-Onsite
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 .
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.
Required Experience:
Senior IC
Employment Type
Full Time
