Manufacturing Associate IV - Wed to Sat - 6am to 4.30pm

Ultragenyx Pharmaceutical • Bedford, MA

1d • Onsite

About The Position

ultra focused – Work together to fearlessly uncover new possibilities The Manufacturing Associate will be a key member of the Downstream/Central Services Manufacturing team responsible for the on-the-floor operations at our Gene Therapy Manufacturing Facility. The Manufacturing Associate will be ensuring GMP compliance as well as writing SOPs and batch records to support plant operations. Must be detail-oriented with troubleshooting abilities. You will be expected to be knowledgeable in purification operations (chromatography, TFF, Viral Filtration, Membrane Filtration) and single-use disposable technology as well as Central Service activities (Weigh/Dispense, Solution Preparation and Glass wash). This role will be for a 4-day 10-hour shift with rotations (Wed-Sat) Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site. This is a shift based position from Wednesday to Saturday 6.30am to 4.30pm.

Requirements

• Typically requires a university degree and a minimum of 4 years of related experience, 2 yr degree with 6+ yrs, or No degree with 8+ years GMP manufacturing experience preferably in pharmaceutical manufacturing.
• Strong collaboration, teamwork, 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).

Responsibilities

• Ensure high standards of cGMP are always adhered to.
• Must be able to efficiently operate the Veeva Vault system for all quality documentation, Deviations, Change Controls and CAPA systems.
• Develop, write, and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks.
• Drive to closure the manufacturing review of the completed batch records in a timely manner per established targets.
• Ensure high standards of cGMP documentation completion are always adhered to.
• Demonstrate a thorough and complete understanding of safety requirements, and GMP compliance of the plant and process.
• An Operational Excellence champion - driving medium level continuous improvements to the process or systems.
• Represents manufacturing in Project team meetings as required.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees