QC Microbiology, Senior Analyst II

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 do. 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 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 work. Ultimately, 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 and personally, come join our team.

Position Summary:

ultra dedicated – Your biggest challenges yield rare possibilities

Reporting to the QC Microbiology Director, the Senior QC Analyst II will support the Ultragenyx gene therapy program pipeline through oversight, review and/or execution of GMP microbiological assays including but not limited to endotoxin, bioburden, conductivity, total organic carbon (TOC) testing, growth promotion, sterility, mycoplasma, container closure integrity testing (CCIT), and in vitro adventitious agent (IVAA) testing. This position is responsible for scheduling laboratory activities and ensuring testing is completed on time and in a compliant manner.

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 (e.g. bioburden, endotoxin, TOC, conductivity, growth promotion, etc.).

• Execute routine, non-routine, and qualification testing of in-house microbiological methods.

• Review and approve cGMP analytical data from utility, release, and stability testing for internally and externally generated data.

• Support and lead QC Microbiology laboratory operations (e.g. monitor incoming samples, schedule microbial testing and qualification of critical media and reagents, ensure QC data packets and logbooks are reviewed within required timelines, etc.).

• Independently own and author quality records including change controls, deviations, CAPAs, invalid assays, excursion investigations, OOS Investigations, etc. with minimal managerial oversite.

• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs).

• Serve as trainer for in-house microbiological methods.

• Lead, or participate in, the development of new methods.

• Model leadership behaviors and mentor/train junior staff.

• Work with internal/external personnel within and outside area of expertise to support cross functional activities.

• Participate in regulatory inspections.

Requirements:

• BS or MS in Microbiology with 6+ years of QC experience.

• Demonstrated knowledge of microbiological methods including endotoxin, 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 with demonstrated experience in controlled document generation in accordance with GMPs.

• Experience with electronic document management systems (EDMS) such as Veeva Vault and 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

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 [email protected] .

See our CCPA Employee and Applicant Privacy Notice.

See our Privacy Policy.

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: [email protected].