Manufacturing Associate III - Evening Shift (Pitman schedule)
Ultragenyx, Bedford, MA, United States
Position Summary
ultra focused – Work together to fearlessly uncover new possibilities
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.
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 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.
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).
Physical Demands
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 makeup, jewelry, and contact lenses while in the manufacturing environment.
Working in temperature‑controlled environments (cold rooms).
Pay Range & Bonuses
The typical annual salary range for this full‑time position is $90,400 USD – $111,600 USD. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this posting. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Benefits
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
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 & Legal Notices
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 talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy.
Legal Notice
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
ultra focused – Work together to fearlessly uncover new possibilities
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.
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 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.
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).
Physical Demands
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 makeup, jewelry, and contact lenses while in the manufacturing environment.
Working in temperature‑controlled environments (cold rooms).
Pay Range & Bonuses
The typical annual salary range for this full‑time position is $90,400 USD – $111,600 USD. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this posting. This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Benefits
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
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 & Legal Notices
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 talentacquisition@ultragenyx.com. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy.
Legal Notice
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