Manager, Drug Product Manufacturing

Ultragenyx•Bedford, MA

9h•Onsite

About The Position

The Manager, Drug Product Manufacturing supports operations at Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, Massachusetts, reporting to the Director of DP Manufacturing. This hands-on manufacturing subject matter expert supports continuous commercial drug product manufacturing, with a focus on filling operations—including vial filling and isolator systems—and visual inspection. The role oversees training and supervision of manufacturing Associates in aseptic filling, visual inspection, labeling, and bulk-pack operations. The role typically requires most work to be conducted onsite.

Requirements

Bachelor’s degree in Engineering or a scientific discipline preferred, or equivalent experience in Business.
Hands-on experience in aseptic operations for filling a parenteral product.
Experience with isolator and/or RABS technology.
Eight years of experience, preferably in pharmaceutical manufacturing or another regulated industry.
Strong collaboration, teamwork, and communication skills.
Self-motivated and detail-oriented, with good problem-solving ability.
Ability to stand for extended periods, with periodic stooping, bending, and kneeling.
Ability to lift, push, and pull up to 50 pounds.
Ability to work in a controlled environment requiring GxP gowning and protective clothing over the head, face, hands, feet, and body, including changing into appropriate gowning and personal protective equipment.
If performing visual inspection processes, ability to pass a vision exam verifying near- and mid-range clarity, depth perception, and color identification and distinction, with or without correction.

Nice To Haves

At least two years of supervisory experience.
Experience training and developing team members.

Responsibilities

Plan and supervise daily execution of tasks in support of the published production plan, and ensure work is completed.
Ensure operators are qualified in accordance with SOPs to support cGMP manufacturing of pharmaceutical products.
Support quality investigations, continuous improvement, and engineering, maintenance, quality control, and quality operations activities that affect manufacturing-area functionality.
Ensure maintenance and upkeep of the facility and processes within the area of responsibility.
Generate, drive, and approve new or revised SOPs, batch records, and protocols supporting equipment and processes in the Drug Product manufacturing area.
Support the definition and execution of activities in compliance with environmental health and safety requirements.
Serve as a manufacturing subject matter expert for drug product filling operations, including vial filling and isolator systems, and visual inspection.
Ensure robust and timely communication of operational and planning activities associated with daily production.
Train and supervise manufacturing Associates in aseptic filling, visual inspection, labeling, and bulk-pack operations.