At a glance

Location: Bedford, MA
Work type: Onsite

What they are looking for

ValidationPlanningDocumentationTestingManufacturing

Location: Bedford, MA Department: Gene Therapy - Validation

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

Ultragenyx has multiple Gene Therapy programs in development in the rare and ultrarare disease space, a robust pipeline. You will partner closely with the Engineering & Validation leadership team and will be responsible for upstream/downstream process & utility validation of GMP manufacturing systems at our state of the art Gene Therapy Manufacturing facility in Bedford, Massachusetts. You will work alongside senior team members and be focused on the planning for the Manufacturing Facility Validation

This will give students a unique perspective on what it is like to support a gene therapy manufacturing site. This will not be a traditional on the floor hands on experience. The person who fills this role will be a part of a team that supports planning, execution, and decision- making for ongoing validation activities.

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

Attend Validation planning meetings

Collaborate with different workstreams

Execute testing on Manufacturing and Utilities Equipment

Documentation development

Generate and maintain project trackers and spreadsheets

Routinely execute simple and complex processes following established SOPs.

Demonstrate general knowledge of standard manufacturing practices and equipment.

Strict adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.

Follow written procedures for clear and accurate documentation of equipment operation and process instructions.

Monitor process operations to ensure compliance with specifications.

Assist in the investigation of procedural deviations.

Practice safe work habits and adhere to safety procedures and guidelines.

Utilize knowledge to improve operational efficiency.

Other duties as assigned

Requirements

Pursuing a bachelor’s degree in a relevant field of study (e.g., engineering or science) with minimum of 2 years completed

Enrolled as a full-time student with plans to return to school in fall term

This co-op is full-time (40 hours per week), from January until the end of June 2027.

Knowledgeable of Microsoft Office Suite (Word, Excel, PowerPoint)

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.

Manufacturing: Facilities Mechanic:

Stand for extended periods of time wih periodic stooping / bending / kneeling.

Ability to climb ladders and stairs of various heights.

Able to lift, push, pull up to 50lbs.

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 use of a respirator; medical clearance will be required in advance.

Must remove all make-up, jewelry, and contract lenses while in the manufacturing environment.

Working in temperature-controlled environments (cold rooms).

The pay range for this position is $25 - $30/hour.

#LI-AJI #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.