Supervisor, Manufacturing Operations (Second Shift)

Vertex Inc.•Boston, MA

3d•Onsite

About The Position

The Manufacturing Operations Supervisor is a critical first-line leadership role within Cell Manufacturing. This position is responsible for direct management of personnel executing GMP cell processing operations for adherent and suspension cell cultures. The candidate will have strong leadership skills, GMP expertise, and commitment to patients. The Supervisor will work one of the following shifts: Second Shift - Tuesday to Saturday, 2:30PM - 11PM or Second Shift - Sunday to Thursday, 2:30PM - 11PM.

Requirements

Extensive GMP experience, including as a lead or trainer
Minimum of 3 years of cell culture experience, ideally in both adherent and suspension cultures
A minimum of 0-2 years direct supervisory experience
Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
Expertise in cell processing and culture technologies for clinical materials production required
Experience with bioreactors for cell culture
Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
Seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Responsibilities

Builds and develops an efficient team of 2-8 direct reports capable of consistently producing clinical cellular product or intermediates according to cGMP standards. Includes hiring, orienting, training and coaching of personnel.
Ensures cGMP compliance through direct oversight and education of team members.
Shares responsibility of scheduling of personnel in coordination with other Manufacturing leadership.
Manages direct reports’ projects to achieve department and corporate goals, including managing timelines and leading group meetings.
Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments.
Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing.
Receive and manage equipment alarms.
Serves as a technical SME for the team, troubleshoots problems independently.
Demonstrates 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.