Manager, Drug Product Manufacturing

The role

The Drug Product Manufacturing Manager supports operations at the Gene Therapy Manufacturing Facility. This person will be a hands-on SME for drug product filling operations and visual inspection while supervising manufacturing Associates.

What you will do

• Plans and supervises daily execution of tasks to support published production plan
• Ensure qualification of operators to support cGMP manufacturing
• Supports quality investigations, continuous improvement, and engineering/maintenance/quality activities
• Ensure maintenance and upkeep of the facility and process
• Generates, drives, and approves new or revised SOPs, batch records, and protocols
• Support the definition and execution of all activity in compliance with EHS requirements
• Act as a manufacturing SME for drug product filling operations, including vial filling and isolator system and visual inspection
• Ensures robust and timely communication of operational and planning activities

Required qualifications

• Hands-on experience in aseptic operations for filling of a parenteral is required
• Experience with isolator and/or RABS technology is required
• Strong collaboration, team-working skills and communication skills
• Independently motivated and detail-oriented with good problem-solving ability
• Stand for extended periods of time with periodic stooping, bending, or kneeling
• Able to lift, push, pull up to 50lbs
• Work in a controlled environment requiring GxP gowning and wear protective clothing
• Must complete and pass a vision exam to verify clarity of vision at near and mid-range, depth perception, and ability to identify and distinguish colors

Nice to have

• BS in Engineering, Scientific Discipline preferred or Business equivalent experience
• 8 years’ experience preferably in pharmaceutical manufacturing or other regulated industry
• Minimum of 2 years of supervisory experience preferred
• Experience training and developing team members is preferred

Benefits

• 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

About the company

Ultragenyx aims to lead the future of rare disease medicine by following science and using a novel rapid development approach. The company focuses on creating a supportive and inclusive environment for its employees.