Why Join Us
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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. 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 we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
ultradedicated Your biggest challenges yield rare possibilities
Reporting to the QC Microbiology Director theSenior QC Analyst II willsupport the Ultragenyx gene therapy programpipelinethroughoversight reviewand/orexecution ofGMP microbiologicalassays including but not limited to endotoxin bioburdenconductivity total organic carbon (TOC)testinggrowth promotionsterilitymycoplasma container closure integrity testing(CCIT)andin vitroadventitious agent (IVAA) testing.This positionis responsible forschedulinglaboratory activitiesand ensuringtesting is completed on timeand inacompliantmanner.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- SME for multiple microbiological assays ( endotoxin TOC conductivity growth promotion etc.).
- Execute routine non-routine andqualification testing of in-house microbiological methods.
- Review and approvecGMP analytical datafromutilityrelease andstability testingforinternallyand externally generateddata.
- Support and leadQC Microbiology laboratory operations ( samplesschedulemicrobial testingandqualification ofcriticalmedia andreagentsensureQC datapacketsand logbooks are reviewedwithin required timelinesetc.).
- Independentlyownand author qualityrecordsincludingchange controlsdeviations CAPAsinvalid assaysexcursioninvestigationsOOS Investigations minimal managerial oversite.
- Write prepare and present technical data technical reports and standard operating procedures (SOPs).
- Serve astrainerfor in-house microbiological methods.
- Leadorparticipatein the development of new methods.
- Model leadership behaviors and mentor/train junior staff.
- Workwithinternal/external personnel within and outsideareaof expertise to support cross functional activities.
- Participate in regulatory inspections.
Requirements:
- BS or MS in Microbiology with6 years ofQCexperience.
- Demonstratedknowledge of microbiological methods includingendotoxin bioburden conductivity total organic carbon (TOC) testing growth promotion sterility mycoplasma container closure integrity testing (CCIT) and in vitro adventitious agent (IVAA) testing.
- Strong technical writing skills withdemonstratedexperience in controlled documentgenerationin accordance withGMPs.
- Experience with electronic document management systems (EDMS) such asVeeva Vaultand LIMS is preferred.
- Strong collaboration and communication skills.
- Independently motivated and detail-oriented with good problem-solving ability.
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.
#LI-CT1 #LI-Onsite
The typical annual salary range for this full-time 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
$118700 - $146600 USD
Full Time employees across the globe enjoy a range of benefits including but not limited to:
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and Employee stock purchase plans or equivalent offerings
Employee wellbeing benefits
Fitness reimbursement
Tuition sponsoring
Professional development plans
* Benefits vary by region and country
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.
Required Experience:
Senior IC
Why Join UsBe a hero for our rare disease patientsAt 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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
Why Join Us
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 achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont 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 do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. 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 we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
ultradedicated Your biggest challenges yield rare possibilities
Reporting to the QC Microbiology Director theSenior QC Analyst II willsupport the Ultragenyx gene therapy programpipelinethroughoversight reviewand/orexecution ofGMP microbiologicalassays including but not limited to endotoxin bioburdenconductivity total organic carbon (TOC)testinggrowth promotionsterilitymycoplasma container closure integrity testing(CCIT)andin vitroadventitious agent (IVAA) testing.This positionis responsible forschedulinglaboratory activitiesand ensuringtesting is completed on timeand inacompliantmanner.
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
- SME for multiple microbiological assays ( endotoxin TOC conductivity growth promotion etc.).
- Execute routine non-routine andqualification testing of in-house microbiological methods.
- Review and approvecGMP analytical datafromutilityrelease andstability testingforinternallyand externally generateddata.
- Support and leadQC Microbiology laboratory operations ( samplesschedulemicrobial testingandqualification ofcriticalmedia andreagentsensureQC datapacketsand logbooks are reviewedwithin required timelinesetc.).
- Independentlyownand author qualityrecordsincludingchange controlsdeviations CAPAsinvalid assaysexcursioninvestigationsOOS Investigations minimal managerial oversite.
- Write prepare and present technical data technical reports and standard operating procedures (SOPs).
- Serve astrainerfor in-house microbiological methods.
- Leadorparticipatein the development of new methods.
- Model leadership behaviors and mentor/train junior staff.
- Workwithinternal/external personnel within and outsideareaof expertise to support cross functional activities.
- Participate in regulatory inspections.
Requirements:
- BS or MS in Microbiology with6 years ofQCexperience.
- Demonstratedknowledge of microbiological methods includingendotoxin bioburden conductivity total organic carbon (TOC) testing growth promotion sterility mycoplasma container closure integrity testing (CCIT) and in vitro adventitious agent (IVAA) testing.
- Strong technical writing skills withdemonstratedexperience in controlled documentgenerationin accordance withGMPs.
- Experience with electronic document management systems (EDMS) such asVeeva Vaultand LIMS is preferred.
- Strong collaboration and communication skills.
- Independently motivated and detail-oriented with good problem-solving ability.
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.
#LI-CT1 #LI-Onsite
The typical annual salary range for this full-time 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
$118700 - $146600 USD
Full Time employees across the globe enjoy a range of benefits including but not limited to:
Generous vacation time and public holidays observed by the company
Volunteer days
Long term incentive and Employee stock purchase plans or equivalent offerings
Employee wellbeing benefits
Fitness reimbursement
Tuition sponsoring
Professional development plans
* Benefits vary by region and country
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.
Required Experience:
Senior IC
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Job Location:
Monthly Salary:
$ 118700 - 146600
Posted on:
8 hours ago
Vacancies:
1 Vacancy
