Manufacturing Associate II – Drug Substance Upstream - 7am to 7pm Pitman rotation

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:

ultradedicated – Your biggest challenges yield rare possibilities

The Manufacturing Associate II will be a suite based position within the Gene Therapy Manufacturing facility. The position is a suite/clean room based position where the Associate II position will be an on the floor technician assigned to the Upstream Manufacturing area. Expertise will include all cell thaw and culture activities through the various scale of bioreactors up to 2000L and harvest operations.

Work Model: 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic. This is a shift based position from 7am to 7pm on a Pitman rotation. 

Responsibilities:

1. Quality Systems

· Be able to operate efficiently the Veeva Vault system for all quality documentation.

· Ensure that high standards of cGMP are adhered to at all times.

· Carry out the manufacturing review of the completed batch records in a timely manner per established targets.

· Assist in Lot Disposition activities as required, including deviation follow ups, comment resolution in a timely manner to adhere to lot release timing

2. Documentation

· Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.

· Support the completion of change control forms and Deviations, plus subsequent implementation of changes and follow up actions.

· Ensure that high standards of cGMP documentation completion are adhered to at all times and documentation is left in a reviewable condition at all times.

3. Plant and Process

· Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.

· Ongoing maintenance of own training, ensuring full training has taken place to support the execution of production activities.

· Identify and drive any continuous Improvements to the process/equipment.

4. Batch Ownership

· Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate.

· Initiation of MFG related Quality Incidents as required.

· Support/ Drive through to completion any projects as required.

5. Miscellaneous

· Ensure high standards of housekeeping are adhered to at all times.

· Participate in internal/regulatory audits as required.

· Ensure effective liaison and communication with other departments, maintaining good relations at all times.

· Ensure that the appropriate safety policies and systems are adhered to in the GTMF suite.

Requirements:

1. High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.

2. 2+ years experience in a Biologics Manufacturing setting

3. Experience with viral vectors would be beneficial for this role

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