Senior Manager, Drug Substance Manufacturing Upstream

Ultragenyx•Bedford, MA

3d•Onsite

About The Position

The Upstream Manufacturing Manager reports to the Sr. Director of Upstream Manufacturing and supervises a shift of five manufacturing technicians and Associates on a rotating 12-hour schedule from 7 a.m. to 7 p.m., with every other weekend off. The primary focus is cell culture operations from vial thaw through 2K operations to produce viral particles for gene therapy products. The role typically requires the majority of work to be conducted on-site and includes on-call responsibility for Upstream Manufacturing alarms outside the shift. The manager oversees manufacturing technicians’ compliance, training, safety, and career development. The role also serves as a project lead for higher-level initiatives, driving projects to completion collaboratively in a matrix environment. It requires maintaining effective communication among Manufacturing managers and ensuring relevant information is shared with support staff. The position has responsibility for quality systems, manufacturing processes, equipment, and facilities. The manager acts as an area lead for audits, hosts tours, presents as a front-room subject matter expert during regulatory inspections, and drives manufacturing review of batch records according to the release plan. The role also owns assigned quality-system activities and supports continuous improvement and business system ownership of equipment and facilities. The work environment includes controlled manufacturing areas requiring GxP gowning and personal protective equipment, temperature-controlled environments such as cold rooms, and occasional respirator use subject to prior medical clearance.

Requirements

Ideally, a degree in Engineering or a scientific discipline; equivalent education or experience may be considered.
Ability to be on call for Upstream Manufacturing alarms outside the shift.
10+ years in leadership positions with direct reports, ideally in a 24/7 biologics environment.
Experience with GMP manufacturing of viral vectors and/or biological processes.
Strong collaboration, teamwork, and communication skills.
Ability to stand for extended periods and periodically stoop, bend, or kneel.
Ability to lift, push, or pull up to 50 pounds and climb ladders and stairs of various heights.
Ability to work in controlled environments requiring GxP gowning and protective clothing, and to change into appropriate gowning and personal protective equipment.
Ability to obtain medical clearance in advance if required to use a respirator.
Must remove makeup, jewelry, and contact lenses while in the manufacturing environment.

Nice To Haves

Degree in Engineering or a scientific discipline.
Leadership experience with direct reports in a 24/7 biologics environment.
Experience with GMP manufacturing of viral vectors and/or biological processes.

Responsibilities

Supervise a shift of five manufacturing technicians and Associates on a rotating 12-hour schedule.
Oversee cell culture operations from vial thaw through 2K operations for viral-particle production for gene therapy products.
Be available on call for Upstream Manufacturing alarms outside the shift.
Act as area lead for internal and external audits as required, including hosting tours.
Serve as a front-room subject matter expert during regulatory inspections.
Drive manufacturing review of completed batch records according to the release plan.
Drive assigned quality-system activities, including deviations, CAPAs, change controls, SOPs, master batch records, and risk assessments.
Ensure materials, personnel, documentation, and other resources needed for processing are available.
Identify continuous improvements to processes and equipment and complete assigned projects.
Demonstrate business system ownership of equipment and facilities.
Oversee direct reports’ compliance, training, safety, and career development.
Lead assigned higher-level initiatives and drive projects to completion collaboratively in a matrix environment.
Maintain strong communication among Manufacturing managers and ensure appropriate dissemination of communications to support staff.