Senior Manager, Manufacturing Operations (3rd Shift)

Vertex Inc.•Boston, MA

6d•$139,100 - $208,700•Onsite

About The Position

The Senior Manager, Manufacturing Operations manages a supervisory team and provides oversight to the day-to-day operations. This position provides strategic and operational leadership to ensure safe, compliant, and efficient execution of cGMP manufacturing operations in alignment with production schedules, site objectives, and business priorities. The Senior Manager is accountable for maintaining an audit-ready facility, driving continuous improvement, building organizational capability, and supporting the successful production of pharmaceutical drug products.

Requirements

Advanced interpersonal, communication, and organizational skills.
Strong leadership and people management skills, with the ability to lead through others and build high-performing teams.
Demonstrated ability to mentor and develop supervisors and emerging leaders.
Strong organizational, planning, and operational management skills, with the ability to manage competing priorities across multiple activities.
Deep knowledge of cGMP principles and associated regulatory expectations in a pharmaceutical manufacturing environment.
Strong understanding of cell therapy manufacturing operations, including process execution, equipment operation, and facility support requirements.
Demonstrated competency in process, equipment, and facility validation experience.
Experience with event investigations, deviation management, CAPA, change control, and inspection readiness.
Proficiency with Quality by Design (QbD) concepts, Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.
Strong problem-solving and decision-making skills, with the ability to assess operational risk, escalate appropriately, and drive resolution.
Ability to improve systems, processes, and team performance through continuous improvement principles.
Ability to clearly communicate technical and operational rationale for procedures, practices, and manufacturing approaches.
Proficiency with manufacturing systems and documentation platforms, including QDoCCS and other GMP systems.
Bachelor’s degree required in a scientific, technical, or engineering discipline.
Typically requires 10+ years of experience or the equivalent combination of education and experience.
Strong experience in direct people supervision in a cGMP manufacturing environment required.
Significant leadership experience in pharmaceutical manufacturing operations within a cGMP-regulated environment required.
Prior experience managing supervisors and/or manufacturing teams.
Prior cell therapy and aseptic manufacturing experience.
Prior POMS MES experience preferred.
Experience supporting commercial and/or late-stage development manufacturing preferred.

Nice To Haves

Prior POMS MES experience preferred.
Experience supporting commercial and/or late-stage development manufacturing preferred.

Responsibilities

Manage and develop a supervisory team, ensuring strong execution, accountability, and team effectiveness.
Direct the activities of the group through management of staff, prioritization, and assignment of tasks.
Responsible for aligning with site leadership to provide departmental and technical leadership.
Assume a project leader role for departmental and interdisciplinary projects.
Ensure work is prioritized, staffed, and executed in alignment with detailed production schedules and business needs.
Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, cleaning, and associated support activities.
Ensure compliant execution, review, and approval of batch documentation and other GMP records.
Provide oversight for real-time on-the-floor batch record review and escalation of operational or compliance issues as needed.
Participate in event investigations, CAPAs, and change controls in support of production and departmental objectives.
Identify and continuously improve practices, procedures, and activities related to the department and site.
Partner cross-functionally to support validation activities, facility readiness, investigations, and manufacturing objectives.
Ensure the facility remains in an audit-ready state through adherence to procedures, documentation standards, and inspection readiness practices.
Monitor and enforce GMP compliance for personnel, processes, and activities.
Drive operational performance through tiered management systems, including leadership of Tier 1 and/or Tier 2 meetings and follow-up on escalated issues.
Monitor manufacturing performance metrics and trends; identify risks and drive actions to improve safety, quality, delivery, and cost.
Enable the timely achievement of departmental, site, and corporate goals.
Mentor, motivate, coach, and evaluate the performance of group members.
Foster interdisciplinary communication, collaboration, and shared understanding within the group and across departments.
Ensure personal and team compliance with all training requirements.
Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
Perform other duties and projects as assigned to meet departmental and business requirements.