Manufacturing Associate III - Evening Shift (Pitman schedule)

Ultragenyx Pharmaceutical•Bedford, MA

21h•Onsite

About The Position

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 III 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. This role typically requires that the majority of the work be conducted on-site.

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 coop, and internship experience is considered.
Experience with viral vectors and/or biological processes.
Strong collaboration, teamwork 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).

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 projects 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 timescale.