Manufacturing Associate III - Evening Shift (Pitman schedule)

Bedford, MA Position Summary The Manufacturing Associate II will be a suite-based position within the Gene Therapy Manufacturing facility. The role is suite/clean room based, scheduled from 7am to 7pm on a Pitman rotation, and involves cell thaw and culture activities through bioreactors up to 2000L and harvest operations. Work Model Core Lab & Ops: The majority of the work is conducted on-site. Responsibilities Maintain own training file ensuring full training has taken place for all aspects of production activities in the GTMF area. Oversee and drive training in the GTMF area to enable efficient and compliant duties. Operate Veeva Vault system for all quality documentation. Ensure high standards of cGMP are adhered to at all times. Revise GMP documents and templates including batch records, SOPs, OJTs and logbooks. Ensure documentation is left in a reviewable condition at all times. Demonstrate ownership of the process, ensuring resources (materials, personnel, documentation) are available. Demonstrate a thorough understanding of safety requirements and GMP compliance. Become a subject matter expert for assigned equipment in the control area. Identify immediate actions or escalation needed to mitigate risk to product, employee safety, or schedule. Identify continuous improvements to the process/equipment and drive projects to completion. Maintain high standards of housekeeping. Participate in internal and regulatory audits as required. Attend projects and other meetings as required. Maintain effective liaison and communication with other departments. Adhere to safety policies and systems in the GTMF suite. Ensure objectives are met within agreed timeline. Requirements High school degree to BS in Engineering, Scientific Discipline, or Business, or equivalent experience. 2+ years’ experience preferably in pharmaceutical manufacturing or regulated industry; internship or cooperative experience considered. Experience with viral vectors and/or biological processes. Strong collaboration, teamwork, and communication skills. Ability and desire to work in a fast‑paced, startup environment. Independently motivated, detail‑oriented with good problem‑solving ability. Proficient in reading, writing, and understanding English; proficient with Microsoft Excel, Word, Outlook. Physical Demand Requirements Stand for extended periods, with periodic stooping, bending, kneeling. Able to lift, push, pull up to 50 lbs. Climb ladders and stairs of various heights. Work in controlled environment requiring GxP gowning and protective clothing. May require use of respirator; medical clearance needed. Must remove all makeup, jewelry, and contact lenses in manufacturing environment. Work in temperature‑controlled environments (cold rooms). Pay Range

$90,400 - $111,600 USD

Benefits Generous vacation time and public holidays observed by the company. Long term incentive and Employee Stock Purchase plans or equivalent offerings. Fitness reimbursement. Benefits vary by region and country. Equal Opportunity Employment 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. Legal Notice It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr Ultragenyx Pharmaceutical Inc.