Manufacturing Associate II – Drug Substance Upstream - 7am to 7pm Pitman rotation

Ultragenyx; Bedford (MA); On-site; USD 78,300 - 96,700; Full time

Benefits offered by this job

Generous vacation time

Volunteer days

Tuition sponsoring

Professional development plans

Job summary

A biopharmaceutical company in Massachusetts seeks a Manufacturing Associate II for Gene Therapy Manufacturing. This role includes working on the Upstream Manufacturing area, ensuring adherence to cGMP standards, operating quality systems, and maintaining documentation. Candidates should have a high school degree or equivalent and 2+ years of experience in a Biologics Manufacturing setting. The position offers a pay range of $78,300 to $96,700 with annual bonuses and equity incentives.

Qualifications

• 2+ years experience in a Biologics Manufacturing setting.
• Experience with viral vectors would be beneficial for this role.

Responsibilities

• Operate the Veeva Vault system for quality documentation.
• Ensure high standards of cGMP are adhered to at all times.
• Create, write and revise GMP documents including batch records and SOPs.

Skills

Biologics Manufacturing

Viral vectors

Documentation

Education

High school degree to BS in Engineering, Scientific Discipline or Business

Job description

Manufacturing Associate II – Drug Substance Upstream - 7am to 7pm Pitman rotation

Manufacturing Associate II – Gene Therapy Manufacturing facility, suite/clean room based position. On floor technician assigned to the Upstream Manufacturing area. Expertise includes all cell thaw and culture activities through various scale bioreactors up to 2000L and harvest operations.

Work Model

This is a shift-based position from 7am to 7pm on a Pitman rotation. The position requires the majority of work to be conducted on-site at the facility.

Responsibilities

• Quality Systems – 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.
• Documentation – 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.
• Plant and Process – 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 continuous improvements to the process/equipment.
• Batch Ownership – identify 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.
• Miscellaneous – 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.

Requirements

• High school degree to BS in Engineering, Scientific Discipline or Business or equivalent in experience.
• 2+ years experience in a Biologics Manufacturing setting.
• Experience with viral vectors would be beneficial for this role.

Physical Demands / Work Environment / Safety Considerations

• Stand for extended periods of time with periodic stooping / bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• 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.
• 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.
• Work in temperature-controlled environments (cold rooms).

Salary

Pay Range: $78,300 USD - $96,700 USD. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

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.
• Benefits vary by region and country.

Equal Opportunity Employer

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, 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. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [e-mail]. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.