Ultragenyx · 1 day ago
Manufacturing Associate II – Drug Substance Upstream - 7am to 7pm Pitman rotation
Bedford, MA
Full-time
Onsite
Entry, Mid Level
$78K/yr - $97K/yr
2+ years expUltragenyx Pharmaceutical is dedicated to leading the future of rare disease medicine. The Manufacturing Associate II will work within the Gene Therapy Manufacturing facility, focusing on upstream manufacturing processes including cell thaw and culture activities and bioreactor operations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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
Carry out the manufacturing review of the completed batch records in a timely manner per established targets
Assist in Lot Disposition activities as required, including deviation follow ups, comment resolution in a timely manner to adhere to lot release timing
Create, write and revise GMP documents and templates including batch records, SOPs, OJTs and logbooks
Support the completion of change control forms and Deviations, plus subsequent implementation of changes and follow up actions
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 a thorough and complete understanding of safety requirements, GMP compliance of the plant and process
Ongoing maintenance of own training, ensuring full training has taken place to support the execution of production activities
Identify and drive any continuous Improvements to the process/equipment
Identification of immediate actions/escalation needed to mitigate risk to product, employee safety or schedule as appropriate
Initiation of MFG related Quality Incidents as required
Support/ Drive through to completion any projects as required
Ensure high standards of housekeeping are adhered to at all times
Participate in internal/regulatory audits 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
Qualification
Required
High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience
2+ years experience in a Biologics Manufacturing setting
Preferred
Experience with viral vectors would be beneficial for this role
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
Company
Ultragenyx
Leading with purpose. Every day.
1001-5000 employees
H1B Sponsorship
Ultragenyx has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (10)
2023 (17)
2022 (16)
2021 (16)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$1.54BKey Investors
Ontario Municipal Employees Retirement SystemAdage Capital Management
2025-11-04Post Ipo Debt· $400M
2024-06-13Post Ipo Equity· $350M
2023-10-18Post Ipo Equity· $300M
Leadership Team
Emil Kakkis
Founder, Chief Executive Officer and President
Howard Horn
Chief Financial Officer and Executive Vice President, Corporate Strategy
Recent News
Genetic Engineering News
2026-01-05
2026-01-03
2026-01-03
Company data provided by crunchbase