Manager, Manufacturing Operations (2nd Shift)

Vertex Pharmaceuticals•Boston, MA

5d•Onsite

About The Position

The Manager, Manufacturing Operations leads cell therapy manufacturing activities and ensures execution aligns with production schedules, operational plans, and business objectives. This role is responsible for defining and directing activities for cell therapy and cell therapy personnel while maintaining organizational balance across the group. This position is accountable for safe, compliant, and efficient cGMP operations, including equipment setup, assembly, operation, disassembly, and cleaning, while providing leadership to supervisors and manufacturing staff. The Manager will foster interdisciplinary communication and understanding within the group and across departments, maintain an audit-ready facility, and support the successful production of pharmaceutical drug products.

Requirements

Bachelor’s degree required, preferably in a scientific, technical, or engineering discipline.
4+ years of experience or the equivalent combination of education and experience.
Prior people leadership experience required, including experience managing staff, supervisors, and/or manufacturing teams.
Experience in pharmaceutical manufacturing operations within a cGMP-regulated environment required.
Strong interpersonal, communication, and organizational skills.
Demonstrated leadership skills, including the ability to lead through others, develop teams, and drive accountability and performance.
Strong capability to mentor, motivate, coach, and develop direct reports and emerging leaders.
Effective interpersonal, verbal, and written communication skills, with the ability to work across functions in a dynamic team environment.
Strong organizational and operational management skills, with the ability to manage competing priorities and maintain timelines across multiple activities.
Sound understanding of relevant drug development and manufacturing activities, including applicable standard operating procedures (SOPs).
Strong problem-solving and decision-making skills, with the ability to assess issues, escalate appropriately, and drive resolution.
Ability to clearly communicate rationale for procedures, practices, and technical approaches.
Demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment.
Solid understanding of process, equipment, and facility validation requirements.
Solid understanding of the cGMP framework in both development and commercial pharmaceutical drug product manufacturing environments.
Working knowledge of inspection readiness, deviation management, CAPA, change control, and continuous improvement practices.
Ability to use manufacturing systems and documentation tools, including QDoCCS and other GMP systems, in support of compliant operations.

Nice To Haves

Prior cell therapy and aseptic manufacturing experience preferred.
Prior POMS MES experience preferred.
Proficiency with Quality by Design (QbD) concepts, Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.

Responsibilities

Lead and manage daily manufacturing operations.
Provide leadership, direction, and support to Manufacturing Supervisors and frontline manufacturing personnel.
Direct the activities of the group through management of staff, prioritization, and assignment of tasks.
Ensure work is assigned and executed in alignment with detailed production schedules, operational priorities, and business needs.
Responsible for aligning with site leadership to provide departmental and technical leadership.
Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, and cleaning.
Ensure accurate execution, authoring, review, and approval of batch documentation to maintain compliant manufacturing records.
Execute and oversee real-time on-the-floor batch record review and escalation of issues as needed.
Author or review and approve batch documentation.
Partner with cross-functional teams to support facility operations, maintenance activities, investigations, deviations, change controls, and manufacturing objectives.
Monitor and enforce GMP compliance for all personnel, processes, and activities.
Maintain the facility in an audit-ready state through adherence to procedures, documentation practices, and inspection readiness standards.
Ensure compliance with SOPs, policies, and work instructions to support safe and successful facility operation.
Identify and continuously improve practices, procedures, and activities related to the department and site.
Drive operational performance through structured tiered management, including leading Tier 1 meetings and supporting Tier 2 escalation and follow-up as needed.
Monitor manufacturing performance metrics and identify opportunities 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.
Lead, coach, and develop supervisors and team members to build organizational capability and support succession planning.
Ensure personal and team compliance with all training requirements.
Foster interdisciplinary communication and understanding within the group and with other departments.
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.