Drug Product Manufacturing Manager - Aseptic Fill & Inspect

Ultragenyx Pharmaceutical; Bedford (MA); On-site; USD 123,000 - 152,000; Full time

Benefits offered by this job

Vacation time

Volunteer days

Stock purchase plan

Wellbeing benefits

Fitness reimbursement

Tuition sponsorship

Professional development

Job summary

Ultragenyx Pharmaceutical in Bedford, MA seeks a Drug Product Manufacturing Manager to oversee aseptic filling operations and visual inspection. You will train and supervise manufacturing associates, ensure cGMP compliance, and support continuous manufacturing at the Gene Therapy facility.

This hands-on role requires a BS in engineering or related field, 8 years pharma experience, and experience with isolator or RABS technology.

Qualifications

• BS in Engineering, Scientific Discipline preferred or Business equivalent experience.
• 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.

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

Skills

Aseptic operations

Supervisory experience

Isolator/RABS

Team collaboration

Problem solving

Education

BS in Engineering or Scientific Discipline

Business equivalent experience

Job description

Ultragenyx Pharmaceutical in Bedford, MA seeks a Drug Product Manufacturing Manager to oversee aseptic filling operations and visual inspection. You will train and supervise manufacturing associates, ensure cGMP compliance, and support continuous manufacturing at the Gene Therapy facility.

This hands-on role requires a BS in engineering or related field, 8 years pharma experience, and experience with isolator or RABS technology.