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

Manufacturing Associate II, Drug Substance Upstream - Gene Therapy - Day Shift (Pitman rotation) Bedford, MA Position Summary: The Manufacturing Associate II will be a suite-based position within the Gene Therapy Manufacturing facility. The role is a suite/clean room-based technician assigned to the Upstream Manufacturing area. Expertise will include all cell thaw and culture activities through the various scales of bioreactors up to 2000 L and harvest operations. The position is scheduled from 12:00 PM to 12:00 AM on a Pitman rotation, with 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. 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, teamwork, 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: Stand for extended periods of time with periodic stooping / bending / kneeling. Able to lift, push, pull up to 50 lbs. 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). 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.

$78,300 - $96,700 USD

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or 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. 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.