Why Join Us
Be a hero for our rare disease patients
At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
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 an Associate 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.
- Provides on-the-floor leadership and development of Manufacturing Technicians across multiple clean rooms
- Sets clear expectations of staff to execute all activities in compliance with cGMP and EHS requirements
- Planning and supervision of daily tasks to achieve master production plan (MPP)
- Ability to be on call for Upstream MFG alarms off shift and manage response accordingly
- Escalate and manage response for manufacturing issues by partnering with support groups
ultrainnovative Tackle rare and dynamic challenges
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
Training
- Ensure efficient and compliant GTMF drug substance operations by mastering production and quality systems overseeing team training and collaborating on training material development.
Quality Systems
- Operate Veeva Vault for quality documentation and lead internal/external audits.
- Ensure cGMP compliance oversee batch record reviews and drive Lot Disposition activities.
- Own and close quality system items including SOPs MBRs risk assessments and validation activities.
Documentation
- Create revise and maintain GMP documents (batch records SOPs OJTs logbooks).
- Manage change controls and deviations ensuring timely implementation and regulatory compliance.
- Uphold high cGMP documentation standards and meet schedule timelines.
Plant and Process
- Ensure readiness of materials personnel and documentation for processing; own upstream equipment.
- Lead Campaign Readiness New Product Introduction and Continuous Improvement initiatives.
- Maintain safety and GMP compliance across plant operations and processes.
Batch Ownership
- Act as first responder to floor issues driving resolution through technical leadership.
- Supervise daily tasks to meet production targets and escalate risks appropriately.
Leadership
- Manage technician performance training safety and career development.
- Lead cross-functional projects and foster strong communication across Manufacturing teams.
Requirements:
- 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 experience including leadership positions with direct reports ideally in Biologics including a 24/7 manufacturing environment
- 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-CT1 #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 applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$123100 - $152000 USD
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
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.
Required Experience:
Manager
Why Join UsBe a hero for our rare disease patientsAt Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means goi...
Why Join Us
Be a hero for our rare disease patients
At Ultragenyx we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to achieve this goal our vision is to lead the future of rare disease medicine. For us this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science applying a novel rapid development approach making innovative medicines at fair and reasonable prices and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them.
Our commitment and care for patients extends to our people so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth so employees can thrive in all areas of their lives in and outside of we want to be an organization where we would be proud for our family friends and children to work.
If you want to have a meaningful impact do the best work of your career and grow a lot both professionally andpersonally come join our team.
Position Summary:
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 an Associate 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.
- Provides on-the-floor leadership and development of Manufacturing Technicians across multiple clean rooms
- Sets clear expectations of staff to execute all activities in compliance with cGMP and EHS requirements
- Planning and supervision of daily tasks to achieve master production plan (MPP)
- Ability to be on call for Upstream MFG alarms off shift and manage response accordingly
- Escalate and manage response for manufacturing issues by partnering with support groups
ultrainnovative Tackle rare and dynamic challenges
Work Model:
Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:
Training
- Ensure efficient and compliant GTMF drug substance operations by mastering production and quality systems overseeing team training and collaborating on training material development.
Quality Systems
- Operate Veeva Vault for quality documentation and lead internal/external audits.
- Ensure cGMP compliance oversee batch record reviews and drive Lot Disposition activities.
- Own and close quality system items including SOPs MBRs risk assessments and validation activities.
Documentation
- Create revise and maintain GMP documents (batch records SOPs OJTs logbooks).
- Manage change controls and deviations ensuring timely implementation and regulatory compliance.
- Uphold high cGMP documentation standards and meet schedule timelines.
Plant and Process
- Ensure readiness of materials personnel and documentation for processing; own upstream equipment.
- Lead Campaign Readiness New Product Introduction and Continuous Improvement initiatives.
- Maintain safety and GMP compliance across plant operations and processes.
Batch Ownership
- Act as first responder to floor issues driving resolution through technical leadership.
- Supervise daily tasks to meet production targets and escalate risks appropriately.
Leadership
- Manage technician performance training safety and career development.
- Lead cross-functional projects and foster strong communication across Manufacturing teams.
Requirements:
- 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 experience including leadership positions with direct reports ideally in Biologics including a 24/7 manufacturing environment
- 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-CT1 #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 applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$123100 - $152000 USD
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
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 .
See ourCCPA Employee and Applicant Privacy Notice.
See our.
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.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us may be directed to:.
Required Experience:
Manager
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Job Location:
Monthly Salary:
$ 123100 - 152000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
