Senior Manager, Drug Substance Manufacturing Upstream

Ultragenyx Pharmaceutical; Bedford (MA); Vor Ort; USD 160.000 - 197.000; Vollzeit

Benefits dieser Stelle

Generous vacation time and public holl

Volunteer days

Employee stock purchase plans or alike

Employee wellbeing benefits

Fitness reimbursement

Tuition sponsoring

Professional development plans

Zusammenfassung

Ultragenyx Pharmaceutical in Massachusetts is seeking an Upstream Manufacturing Manager to oversee a shift of five manufacturing technicians on a 12-hour rotating schedule, focusing on cell culture operations from vial thaw to 2K viral particle production for gene therapy products. The role reports to the Sr.

Director of Upstream Manufacturing and requires on-site work with quality systems ownership, audit readiness, and collaboration across a matrix environment to drive continuous improvements

Qualifikationen

• Degree in Engineering or Scientific Discipline; relevant education/experience.
• On-call for upstream MFG alarms off shift.
• 10+ years leadership with direct reports ideally in Biologics environment running 24/7.
• Experience with GMP manufacturing of viral vectors and/or biological processes.

Aufgaben

• 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.
• Own the process resources to ensure that all resources required for processing are available.
• Identify any Continuous Improvements to the process/equipment and drive through to completion any projects.
• Ensure Business System Ownership (BSO) ownership of the equipment and facility is demonstrated at all times.
• Lead technicians and ensure training, safety and career development within Ultragenyx.

Kenntnisse

Leadership

Teamwork

Communication

Ausbildung

Degree in Engineering or Scientific Discipline

Jobbeschreibung

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 do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't 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 work. Ultimately, 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 and personally, come join our team.

Position Summary:

ultra focused - 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.

Work Model:

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.

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 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.

Pay Range

$159,500-$197,100 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 [e-mail]

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