Intern – Manufacturing Associate

Position Summary:

ultracurious – Apply your biggest ideas in courageous ways

The Ultragenyx Gene Therapy team is headquartered in Cambridge and this position will be located within our state-of-the-art GMP Manufacturing facility in Bedford, MA. We are looking for exceptional individuals who share our passion for developing novel therapies to treat rare diseases and advancing the field of gene therapy. 

Ultragenyx has multiple Gene Therapy programs in development, a robust pipeline, and we are building a state-of-the-art GMP manufacturing facility in Bedford, MA. Join our team! 

Work Model: 

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

Responsibilities:

• Attend daily manufacturing Tier 1 meetings
• Generates / Reviews / Approves new and current SOP’s, batch records, and/or protocols in support of the equipment and manufacturing processes associated with the Central Service manufacturing areas.
• Supports quality investigations, continuous improvement efforts and engineering activities as they directly impact the functionality of the manufacturing areas. 
• Demonstrated ability to work with colleagues who represent a diversity of work and conflict resolution styles 
• Ensure maintenance, upkeep, and organization, of the facility and processes within the Central Service manufacturing areas.
• Demonstrate 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 and complete process operations to ensure compliance with specifications (Parts Washer, Autoclave, Weigh and Dispense, and Solution Preparation).
• Practice safe work habits and adhere to safety procedures and guidelines.
• Utilize knowledge to improve operational efficiency.

Requirements:

• Participating in the Middlesex Community College Learn and Earn Program and in the process of obtaining an associate degree
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).
• Ability and desire to work in a fast-paced, environment is essential 
• Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations. 
• Solution oriented to a variety of problems of minor scope and complexity.
• GMP experience a plus
• Ambitious and self-starting attitude to take on responsibilities and own process improvements
• Ability to collaborate fluidity with peers, supervisors and cross functional support groups
• 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).