Senior Manager, Drug Substance Manufacturing Upstream

Ultragenyx; Bedford (MA); Presencial; USD 160.000 - 197.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Generous vacation time and public holi

Long term incentive

Employee stock purchase plans

Fitness reimbursement

Descripción de la vacante

Ultragenyx is seeking a Senior Manager, Drug Substance Manufacturing Upstream in Bedford, MA. The role leads a shift of technicians on a 12-hour schedule focused on cell culture from vial thaw to 2K viral particle production for gene therapy products.

On-site work is typical, with leadership responsibilities and compliance oversight. Requirements include a degree in engineering or sciences, 10+ years in leadership, and experience with GMP manufacturing of viral vectors.

Formación

• Degree in Engineering or Scientific Discipline or equivalent experience.
• Experience leading teams in biologics or viral vector manufacturing environments.
• Strong collaboration and communication skills across functions.

Responsabilidades

• Act as Area Lead for internal/external audits and site tours.
• Lead regulatory inspection readiness and host inspections.
• Drive batch release reviews per the release plan.
• Own quality system items (Deviations, CAPA, Change Control) and SOP MBRS.
• Ensure resources (materials, personnel, documentation) are available for processing.
• Champion continuous improvement projects for processes/equipment.
• Ensure ownership of equipment and facility by the Business System.

Conocimientos

Leadership

GMP manufacturing

Biologics

Regulatory inspections

Educación

Engineering or scientific discipline

Descripción del empleo

Senior Manager, Drug Substance Manufacturing Upstream

Bedford, MA

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.
• 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).

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.

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
• Long term incentive and Employee stock purchase plans or equivalent offerings
• Fitness reimbursement
• 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].