Manager, Investigations - Facilities and Engineering at Ultragenyx in Bedford, 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:

As an investigator, you will lead and participate in investigation teams to identify root causes, assess risk, evaluate product and process impact, develop effective CAPAs and provide recommendations on batch disposition for deviations. You will provide subject matter expertise on GMP facilities, utilities, equipment, and associated validation, and their impact on manufacturing processes to support deviations.

ultrainnovative – Tackle rare and dynamic challenges

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic.

Responsibilities:

Apply Ultragenyx's business processes for deviations and investigations to complex facilities, equipment, and environmental-related deviations
Performs thorough, detailed and timely deviation investigations and generation of high quality and timely investigation reports
Apply and coach others on the use of Root Cause Analysis (RCA) tools such as 5 Whys, Fishbone, Is-Is Not, and Scatterplot in support of investigations and deviation reports
Develop collaborative relationships with related functions including Facilities/Engineering teams, Manufacturing Operations, Quality Assurance, MSAT, Quality Control, Validation, and Pharmaceutical Development
Leverage process and equipment knowledge, Quality and Operational Excellence toolkits in completing thorough investigations
Coach others team members on investigation and RCA tools
Analyze trends for Engineering and Facilities deviations
Represent Technical Operations in relation to deviation trends, metrics, and performance
Provide regular updates to investigation stakeholders
Support and represent complex investigations to Health authorities during inspections

Requirements:

Minimum B.S. degree in scientific field such as engineering, microbiology, chemistry or biochemistry
8+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Facilities, Engineering, or Quality roles
Fundamental understanding of the investigation process as it applies to GMP systems such as facilities (including HVAC and cleanroom), clean utilities, automated process equipment, calibrations/ maintenance, manufacturing and laboratory issues
Ability to coordinate and facilitate meetings, lead conversations and influence teams
Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products
Demonstrated ability to communicate technical information or complex situations to stakeholders in a concise and clear manner
Technical knowledge of the processes and systems involved in the manufacturing of biologics and ATMPs
Experience with or ability to learn Six Sigma / DMAIC and investigation management techniques
Ability to facilitate and use structured problem solving and Root Cause Analysis tools including 5 Whys, Fishbone, Is-Is Not, Scatterplot
Excellent technical writing skills. Prior experience authoring technical reports and regulatory submissions is desired
Strong verbal communication skills. Demonstrated ability to communicate technical information or complex situations to senior leadership and/or health authority inspectors in a concise and clear manner

#LI-CK1 =

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$131,100—$161,900 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.

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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.