Manufacturing Associate II - Day Shift (Monday-Friday)

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:

ultrafocused – Work together to fearlessly uncover new possibilities

Our Manufacturing Associates support Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, MA. In this role you will report to the Associate Director of Drug Product. The Associates will be involved in daily process review meetings, routine formulation/filling operations and visual inspection of finished Drug Product vials. Must be detail-oriented with troubleshooting abilities. You will be expected to be knowledgeable in cleaning and operation of equipment (parts washers, autoclaves/sterilizers, fillers, and isolators in a clean room environment), sterile gowning, and primary labeling/packaging operations. 

Work Model:

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

Shift Information

This is a shift based position from 7am to 3.30pm Monday to Friday. 

Responsibilities:

1. Support the execution of all activities in compliance with environmental health and safety (EHS) requirements, and good manufacturing procedures (cGMPs) 
2. Follows written procedures and document results in a neat and accurate manner according to GMP standards and other regulations 
3. Supports quality investigations, continuous improvement efforts, and engineering activities as they directly impact the functionality of the manufacturing areas. 
4. Operate and maintain drug product manufacturing equipment and support the maintenance process. 
5. Execute Drug Product setup and breakdown of all equipment 
6. Execute visual inspection of sterile filled containers (vials) in accordance with all applicable procedures, regulations and safety directives 
7. Ensure maintenance and upkeep of the facility and processes within area of responsibility 
8. Maintain training and qualification to enable aseptic processing operations  
9. Ensure the controlled spaces maintain the required inventory and are equipped with the necessary materials, tools, and equipment. 
10. Maintain manufacturing records that comply with CGMPs and internal quality system requirements 

Requirements:

1. High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience 
2. 2+ years’ experience preferably in pharmaceutical manufacturing or other regulated industry  
3. Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations. 
4. Experience with viral vectors is not required but preferred 
5. Ability and desire to work in a fast-paced is essential 
6. Strong collaboration, team-working skills and communication skills 
7. Independently motivated and detail-oriented with good problem-solving ability