Associate Director, Investigations 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:

ultradedicated – Your biggest challenges yield rare possibilities

As a lead investigator, you will lead investigation teams to identify root cause, evaluate product and process impact, develop effective CAPA and provide recommendations on batch disposition for deviations of high complexity. You will provide subject matter expertise on manufacturing processes to support deviations owned by other departments.

Work Model:

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

Responsibilities:

Capability to resolve complex technical manufacturing investigations/projects related to cell and gene therapy manufacturing.
Responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
Expert in the use of Root Cause Analysis tools such as 5 Whys, Fishbone, Is-Is Not, and Scatterplot.
Experience in the use of Human Error Reduction techniques also required.
Ability to develop collaborative relationships with all departments including operations, MSAT, quality control, quality assurance, Pharmaceutical Development, and Facilities/Engineering teams.
Contribute to business processes for investigation of manufacturing deviations, leveraging process knowledge, Quality and Operational Excellence toolkits.
Provide regular updates to Senior leadership. Represent complex investigations to Health authorities during inspections.

Requirements:

Minimum B.S. degree in scientific field such as microbiology, chemistry or biochemistry
8+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Manufacturing and Quality roles.
3+ years of Quality leadership/management experience preferred
Fundamental understanding of the investigation process as it applies to manufacturing and laboratory issues. Experience presenting investigations to Health Authorities during inspections a plus.
Ability to coordinate and facilitate meetings, lead conversations and influence teams.
Comprehensive 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 senior leadership and/or health authority inspectors in a concise and clear manner.
Technical knowledge of the processes and systems involved in the manufacturing of biologics and ATMPs
Strong knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products
Six Sigma / DMAIC and investigation management background. Expert in facilitation and use of structured problem solving and Root Cause Analysis tools including 5 Whys, Fishbone, Is-Is Not, Scatterplot. Experience in the use of Human Error Reduction techniques desired
Excellent technical writing skills. Prior experience authoring technical reports and regulatory submissions required
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-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$162,400—$200,600 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.