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Bedford, Massachusetts, United States
Onsite
ultrafocused – Work together to fearlessly uncover new possibilities
The Upstream Manufacturing Manager will report to the Sr. Director of Upstream Manufacturing. The role will be responsible for the supervision of a shift of 5 manufacturing technicians and Associates on a rotating pitman (every other weekend off) 12 hour schedule (7am-7pm). The roles primary focus will be on cell culture operations from vial thaw through to 2K operations for the production of viral particles for gene therapy products.
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
Quality Systems:
• Act as Area Lead for internal/external Audits as required, including hosting tours.
• Front room SME presenting for regulatory inspections.
• Drive the manufacturing review of the completed batch records per the release plan.
• Driver of all assigned quality system items (Deviations, CAPA, Change Control), SOPs, MBRs, Risk Assessments etc.
Plant & Process:
• Demonstrate ownership of the process to ensure that all resources (materials, personnel, documentation etc.) required for processing are available.
• Identify any Continuous Improvements to the process/equipment and drive through to completion any projects to which may be assigned.
• Ensure Business System Ownership (BSO) ownership of the equipment and facility is demonstrated at all times.
Leadership:
• Oversight and responsibility for technicians that report into the role, including compliance, training, safety and career development within Ultragenyx.
• The Manager will also be assigned as a “project lead” on higher level initiatives and expected to drive projects to completion in a highly collaborative manner in a matrix environment.
• Leader ensures a calm, strong and robust communications between all managers within Manufacturing and ensuring the appropriate dissemination of communications to support staff.
· Ideally, degree in Engineering or Scientific Discipline, equivalent education/experience could be considered.
· Ability to be on call for Upstream MFG alarms off shift.
· 10+ years leadership positions with direct reports ideally in Biologics environment running 24/7.
· Experience with GMP manufacturing of viral vectors and/or biological processes.
· Strong collaboration, team-working skills, and communication skills.
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. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
· 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.
· Working in temperature-controlled environments (cold rooms).
#LI-KJ1 #LI-Onsite
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
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.