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
The Manufacturing Associate III will be a key member of the Drug Substance/Central Services Manufacturing team responsible for the on-the-floor operations at our Gene Therapy Manufacturing Facility. The Manufacturing Associate will be ensuring GMP compliance as well as writing SOPs and batch records to support plant operations. Must be detail-oriented with troubleshooting abilities. The individual will be expected to be knowledgeable in purification operations (chromatography, TFF, Viral Filtration, Membrane Filtration) and single-use disposable technology as well as Central Service activities (Weigh/Dispense, Solution Preparation and Glass wash). *Initially, this will be a first shift 6am to 2.30pm Monday to Friday position moving to a 4 day 10 hour shift with rotations (Sun-Wed/Wed-Sat) from September.

REQUIREMENTS:

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent experience
• 2-4 years’ experience in a Biologics Manufacturing Setting
• GMP manufacturing experience preferably in pharmaceutical manufacturing.
• Strong collaboration, teamwork, and communication skills
• Independently motivated and detail-oriented with good problem-solving ability.
• Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

PHYSICAL DEMAND REQUIREMENTS:

• 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).
  #LI-Onsite #LI-CT1

• Ensure high standards of cGMP are always adhered to.
• Must be able to efficiently operate the Veeva Vault system for all quality documentation, Deviations, Change Controls and CAPA systems.
• Develop, write, and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.
• Drive to closure the manufacturing review of the completed batch records in a timely manner per established targets.
• Ensure high standards of cGMP documentation completion are always adhered to.
• Demonstrate a thorough and complete understanding of safety requirements, and GMP compliance of the plant and process.
• An Operational Excellence champion - driving medium level continuous improvements to the process or systems.
• Represents manufacturing in Project team meetings as required.