Co-Op, Drug Substance Upstream- Gene Therapy

Ultragenyx - Bedford, MA

Full-time - Intern

Bedford, MA

Professional, Scientific, and Technical Services

About the position

The position involves providing upstream and downstream process and utility engineering support for GMP manufacturing systems at Ultragenyx's new Gene Therapy Manufacturing facility in Bedford, Massachusetts. The role requires collaboration with the Engineering & Validation leadership team to implement innovative solutions and develop engineering programs and standards for the manufacturing 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
• Available to work 40 hours/week during normal business hours
• 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
• 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

Nice-to-haves

• GMP experience is a plus

Benefits

• 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