Senior Quality Control Analyst II, Bioassay at Ultragenyx in Woburn, MA

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:

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 AAV-based gene therapy programs. The Senior QC Analyst II will perform cell-based 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 on-site.

Responsibilities:

Performing routine QC testing including, but not limited to, 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.
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 late-stage assays for AAV-based 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 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:

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-CS1 #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 applicant's 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$117,200—$144,800 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 talentacquisition@ultragenyx.com.

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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: talentacquisition@ultragenyx.com.