Senior Quality Control Analyst II Bioassay
Senior Quality Control Analyst II Bioassay
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$ 117200 - 144800
1 Vacancy
Job Description
Position Summary:
ultrafocused Work together to fearlessly uncover new possibilities
This position is in the Ultragenyx Gene Therapy Quality Control Bioassay group. The Senior QC Analyst II will work with others in Quality Control and Analytical Development in a dynamic environment to support AAVbased gene therapy programs. The Senior QC Analyst II will perform cellbased bioassays ELISAs and other biological methods in a GMP setting. In addition the Senior QC Analyst will review enter and approve data from 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.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted onsite.
Responsibilities:
- Performing routine QC testing including but not limited to quantitative PCR and cellbased 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.
- Supports and leads QC Bioassay laboratory operations (ex. Instrument qualification and maintenance. Passage cells qualify critical reagents etc).
- Author and support quality events; Change controls Deviation CAPA OOS Investigation as needed.
- Support method transfer and validation activities for development technical transfer and validation of latestage assays for AAVbased gene therapy programs.
- Author analytical method performance trend reports as needed.
- Write prepare and present technical data technical reports and standard operating procedures (SOPs).
- Model leadership behaviors and mentor/train junior staff
- Work with cross functional teamswith 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 cellbased 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 fastpaced environment
- Strong collaboration teamworking skills and communication skills
- Independently motivated and detailoriented with good problemsolving ability
- Strong communication interpersonal and organizational skills
Physical Demand Requirements:
- 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. #LICS1#LIOnsite
The typical annual salary range for this fulltime position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$117200 $144800 USD
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
