Senior Specialist, Manufacturing Operations (2nd Shift)

Job Description

The Manufacturing Operations Senior Specialist serves in a project lead role within Cell Manufacturing . This position is responsible for driving projects to completion within the GMP cell processing operations team.

The incumbent will have expertise in cell culture and GMP as well as exceptional project management skills.

The work schedule for this position is Wednesday-Saturday, 2nd shift (12 : 30 pm - 11 pm) for a total of 40 hours / week.

Key Duties and Responsibilities :

• Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, reporting deviations
• Provides experience-related information to drive more efficient technology transfer and final process development from the Development to the Manufacturing group.

Assists in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups

• Ensures cGMP compliance through manufacturing oversight and tracking
• Monitors scheduling and assists with coordinating resources such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities
• Manage individual projects, including managing timelines and leading small group meetings
• Receive and manage equipment alarms
• Serves as the main technical SME for the team, troubleshoots problems independently
• Demonstrate the Vertex Phenotype behaviors : Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration;

Drive Breakthrough Results; and Promote Enterprise Thinking.

Other duties and projects as assign as required to meet departmental requirements

Knowledge and Skills :

• Minimum of 3 years cell culture experience, ideally in both adherent and suspension cultures
• Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems
• Extensive experience with technical writing
• Minimum 6 years working experience in relevant field (may be reduced based on education level)
• Extensive GMP experience, including as a lead or trainer
• Expertise in cell processing technologies for clinical production
• Experience with bioreactors for cell culture
• Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)

Environment :

• Works in a cleanroom and office setting
• Must be able to remain in a stationary position 50% during processing activities
• Frequently move about inside the cleanroom to accomplish process tasks
• Occasionally moves lab equipment and materials weighing up to 50 pounds.
• Compressed gasses and LN2 are used in this process

Flex Designation : On-Site Designated

On-Site Designated

Flex Eligibility Status :

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.