Manager, Upstream Manufacturing - Drug Substance (7am to 7pm)

Manager, Upstream Manufacturing - Drug Substance (7am to 7pm)

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 role's 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

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)

Pay Range

$123,100 - $152,000 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 talentacquisition@ultragenyx.com.