Engineer III, Manufacturing Sciences and Technology (MSAT)

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

The Engineer III/Sr. Engineer, Manufacturing Sciences and Technology will lead or support technology transfer and process validation for the early- and late-phase AAV manufacturing processes at both internal and contract manufacturing facilities.

Work Model

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities

• Serve as the viral vector Drug Substance (DS) Downstream Process Subject Matter Expert (SME).
• Lead or support technology transfers of AAV DS processes from the development teams to internal or external manufacturing facilities.
• Lead or support DS Process Performance Qualification and Continued Process Verification (CPV) for late phase AAV Gene Therapies.
• Support Identification and assessment of single-use components, Manufacturing Bill of Materials (BOM) creation, and process fit for new equipment and consumables.
• Author technical documents owned by MSAT, including process control strategy documents, facility fit, process change assessment, FMEA, tech transfer plan, sampling plans, Engineering run and GMP campaign summary reports, investigation reports and other technical and risk assessment documents. Author or review manufacturing SOPs, work instructions and Master Batch Records.
• Solve complex problems of downstream processes. Leverage process expertise and Operational Excellence approach to lead / address process/operational deviations and manufacturing investigations, supporting timely close-out of quality documents including change controls, product impact assessment, root cause identification, and CAPAs in Veeva QMS
• Monitor and trend manufacturing process data and communicate manufacturing campaign updates to the cross-functional team.
• Author manufacturing sections of regulatory filings and respond to health authority information requests.
• Lead cross-functional meetings and present results, investigation outcomes, and learnings and represent the department on cross-functional project teams with minimal supervisor oversight.
  
  

Requirements

• BS/MS in a scientific field of study, preferably an Engineering degree with 6 years of relevant experience working in the Manufacturing/Contract Manufacturing or Pharmaceutical Development.
• Biologics experience required, AAV and late-stage/commercial experience preferred. Downstream Process Knowledge of Biologics manufacturing required.
• Experience supporting PPQ and CPV programs.
• Experience performing continuous process monitoring, providing on-floor technical support, owning and management of change control, deviations, and CAPAs in Quality systems.
• Demonstrated problem-solving ability and strong communication and technical writing skills
• Ability to work independently and as part of a team. Strong collaboration and team building, communication, and organizational skills required.
• Six Sigma / Lean management background.
  
  

Physical Demands/Work Environment/Safety Considerations

• 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.
  
  

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$110,800—$136,900 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.

See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.PDN-9e5b3474-f72f-4fab-9ec9-82a43e3f0a48