Co-Op, Drug Substance Upstream- Gene Therapy 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:

ultracurious – Apply your biggest ideas in courageous ways

You will partner closely with the Engineering & Validation leadership team and will be responsible for upstream/downstream process & utility engineering support of GMP manufacturing systems at the new state of the art Gene Therapy Manufacturing facility in Bedford, Massachusetts.

You will work alongside senior team members on engineering challenges and objectives and be expected to implement innovative and robust solutions. In addition, you would provide input on the development of engineering programs, standards, and processes for the new manufacturing site.

Work Model:

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

Responsibilities:

Attend MFG and Validation planning meetings and collaborate with different workstreams
Execute simple and complex processes/testing.
Demonstrate general knowledge of standard manufacturing practices and equipment.
Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Help to establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data.
Monitor process operations to ensure compliance with specifications.
Assist in the investigation of procedural deviations.
Support the definition and execution of all activities in compliance with environmental health and safety (EHS) requirements, and good manufacturing procedures (cGMPs)
Assist in development of a single use database for the site’s component library
Supports quality investigations, continuous improvement efforts and engineering activities as they directly impact the functionality of the manufacturing areas.

Requirements:

Pursuing a Bachelor’s degree in a relevant field of study (e.g., Engineering, Science), with minimum of 2 years completed
Enrolled as a full-time student with plans to return to school in fall term
This is a 6 month co-op, starting in January 2025 working until the end of June 2025.
Available to work 40 hours/week during normal business hours
Flexible; adapts work style to meet organization needs
Meticulous attention to detail
Strong ability to follow through with tasks
Ability to exercise sound judgment, reasoning, and problem solving
Capable of completing assigned responsibilities and keeping manager informed of work status
GMP experience is a plus
Ambitious and self-starting attitude to take on responsibilities and own process improvements
Ability to collaborate fluidly with peers, supervisors and cross functional support groups required
Exceptional written, oral communication, and organizational skills required independently and with strategic collaborators

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 controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
Certain tasks may require the use of a respirator; medical clearance will be required in advance.
Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
Working in temperature-controlled environments (cold rooms). #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 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.