Manufacturing Associate II, Drug Substance Upstream - Gene Therapy - Day Shift (Pitman rotation)

Responsibilities

• Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area.
• Overseeing and driving their training in the GTMF area to enable them to carry out their duties efficiently and compliantly.
• 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.
• Revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.
• 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.
• Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available.
• Demonstrate a thorough and complete understanding of safety requirements, GMP compliance of the plant and process.
• Strive to become a subject matter expert for all "assigned" equipment in the area of control.
• Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate.
• Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.
• Ensure high standards of housekeeping are adhered to at all times.
• Participate in internal/regulatory audits as required.
• Attend project and other meetings 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.
• Ensure that objectives given are met in the appropriate agreed to timescale.

Requirements

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.
• 4+ years' experience preferably in pharmaceutical manufacturing or other regulated industry co-op, and internship experience is considered.
• Experience with viral vectors and/or biological processes.
• Strong collaboration, team-working skills and communication skills.
• Ability and desire to work in a fast-paced, start-up environment is essential.
• 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
• General Manufacturing: Drug Substance/Central Svcs:
• 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

Benefits

Additional Information

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: ultra focused - Work together to fearlessly uncover new 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. The position is scheduled from 12:00 PM to 12:00 AM on a Pitman rotation, with the potential to transition to a 7:00 PM to 7:00 AM shift based on facility demand. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

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