Manufacturing Associate IV

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 innovative - Tackle rare and dynamic challenges

We are looking for ultrainnovative person to tackle rare and dynamic challenges in an innovative way. The Manufacturing Associate III will be a suite-based position within the Gene Therapy Manufacturing facility.

The position is a suite / clean room based position where the Associate 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.

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.

Responsibilities : Training

Training

Ongoing maintenance of own training file ensuring full training has taken place for all aspects of the production activities in the GTMF area.

Train less experience operators on the Upstream Process.

Lead the training of Junior staff.

Quality Systems

• Be able to operate efficiently the Veeva Vault system for all quality documentation.
• Own and rive to closure assigned quality system records.

Documentation

• Create, write and 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.
• Review log books and MBRs to allow first time right quality closure.

Plant and Process

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.

Take the "daily" lead with scheduling and planning all daily activities occurring on the floor.

Miscellaneous

• Ensure high standards of housekeeping are adhered to at all times.
• Attend project and other meetings as required. Ensure effective liaison and communication with other departments, maintaining good relations at all times.

Participate in internal / regulatory audits as required.

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

Requirements :

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.
• 5+ years' experience in a Biogics Manufacturing setting
• Experience with viral vectors would be beneficial for this role.
• Ability and desire to work in a fast-paced, start-up environment is essential.
• Strong collaboration, team-working skills 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 Demands / Work Environment / Safety Considerations :

• Stand for extended periods of time with periodic stooping / bending / kneeling.
• Able to lift, push, pull up to 50lbs
• 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. #LI-CK1 #LI-Onsite

Full Time employees across the globe enjoy a range of benefits, including, but not limited to :

• Generous vacation time and public holidays observed by the company
• Volunteer days
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits
• Fitness reimbursement
• Tuition sponsoring
• Professional development plans
• Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and / or local laws.

Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs.

Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected] .

See our CCPA Employee and Applicant Privacy Notice . See our Privacy Policy . Note to External Recruiters : All candidate activity and open positions are managed strictly through our Human Resources Department.

Our Human Resources Department kindly requests that recruiters not contact employees / hiring managers directly in an attempt to solicit business and present candidates.

Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization.

Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.

Inquiries on developing a recruiting relationship with us, may be directed to : [email protected] . PDN-9bc96697-fba0-447e-91dd-c18672a58e49