Manager, Drug Product Manufacturing

Position Summary:

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The Manager Manufacturing, Drug Product will report to the Director of DP Manufacturing. The Drug Product Manufacturing Manager will support the operations of Ultragenyx’s Gene Therapy Manufacturing Facility in Bedford, MA. The Drug Product Manufacturing Manager will be a hands-on manufacturing SME for drug product filling operations and visual inspection. You will support continuous commercial manufacturing for Drug Product operations. You will be responsible for the training and supervision of manufacturing Associates for the aseptic filling area, and visual inspection and labeling/bulk pack operations.

Work Model:

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

Responsibilities:

• Plans and supervises daily execution of tasks to support published production plan and supervises completion of work  

• Ensure qualification of operators, consistent with SOP, to support cGMP manufacturing of pharmaceutical products 

• Supports quality investigations, continuous improvement efforts and engineering/maintenance/quality control/quality operations activities as they directly impact the functionality of the manufacturing area 

• Ensure maintenance and upkeep of the facility and process employed within the area of responsibility 

• Generates / Drives / Approves new/revised SOP’s, batch records, and/or protocols in support of the equipment and manufacturing processes associated with the Drug Product manufacturing area 

• Support the definition and execution of all activity in compliance with environmental health and safety (EHS) requirements. 

• You will be a manufacturing SME for drug product filling operations, including vial filling and isolator system and visual inspection. 

• Ensures robust and timely communication of defined operational / planning activities associated with the execution of daily production 

Requirements:

• BS in Engineering, Scientific Discipline preferred or Business equivalent experience 
• Must have hands-on experience in aseptic operations for filling of a parenteral is required.  
• Experience with isolator and/or RABS technology is required. 
• 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 
• Strong collaboration, team-working skills and communication skills 
• Independently motivated and detail-oriented with good problem-solving ability 

Physical Demand Requirements (On the floor support/supervision may be occasionally required):  

Manufacturing: Drug Product

• Stand for extended periods of time with periodic stooping / bending / kneeling 

• Able to lift, push, pull up to 50lbs 

• 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. 

• 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 with or without correction. 

• Only if performing Visual Inspection processes 

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