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
8. Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook)
9. Willingness to perform “hands on” work in a cleanroom environment. Gowning and aseptic processing experience essential.
10. Thorough knowledge of GMP’s and a clear understanding of EH&S regulations that pertain to the operations function

.Physical Demand Requirements:

Manufacturing: Drug Product Manufacturing Assoc:

• Stand for extended periods of time with periodic stooping / bending / kneeling

• 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.

• Must complete and pass a vision exam to verify clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors with or without correction.

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