Intern, Manufacturing Associate, Upstream (12pm-12am Pitman)

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:

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. Thi