Manufacturing Manager

Job Description

The Manufacturing Manager - Swing Shift leads a manufacturing team assigned to evening/overnight operations supporting TCR T, CAR T, and allogeneic cell therapy programs. This role is accountable for safe, compliant, and reliable execution on the direct manufacturing floor, including late APH receipt and processing, downstream schedule adherence, resource and workload management, right first time execution, team development, Tier 2 performance management, cross-functional escalation, and effective shift handover. The Swing Shift Manager also serves as the Manufacturing point of contact for the GMP facility cleaning and sanitization vendor and the gowning vendor.

Purpose and Scope

The Manufacturing Manager - Swing Shift translates manufacturing strategy into controlled evening/overnight execution. This includes managing staffing, scheduling, floor readiness, late APH response, production flow, deviation support, training progress, vendor coordination, and continuous improvement. The role is expected to lead through presence on the floor, strong communication, coaching, one-on-ones, disciplined escalation, standard work, and clear handover to day-shift leadership. The role also coordinates after-hours support needed to protect patient supply and process timing.

Typical Accountabilities

Lead daily manufacturing operations for an assigned shift, area, or functional team.

Lead the Manufacturing Swing Shift operating model, nominally 1500-0130 on either Sun-Wed or Wed-Sat, with schedule adjustments as required by patient demand and the approved operating model.

Coordinate after-hours support and escalation with Quality, MSAT, QCA, QCM, Supply Chain, EHS, Facilities and Engineering, and other support functions as required to maintain compliant manufacturing execution.

Serve as the Manufacturing liaison and primary point of contact for the GMP facility cleaning and sanitization vendor and the gowning vendor.

Manage the operational relationship with these vendors, including service schedule alignment, staffing and site-access coordination, performance/KPI review, action tracking, issue escalation, and follow-up on recurring service, quality, or compliance concerns.

Ensure cleaning, sanitization, room-turnover, and gowning services are aligned with Swing Shift production windows and next-shift readiness, and escalate vendor service failures that could affect contamination control, GMP readiness, or patient supply.

Provide on-floor support and oversight as a meaningful portion of the role, with a focus on safety, quality, execution discipline, and team coaching.

Ensure production activities are executed safely, compliantly, and according to approved procedures.

Manage staffing, scheduling, work assignments, workload management, and production readiness to meet patient supply demand.

Ensure personnel, materials, equipment, documentation, electronic systems, and cleanroom areas are ready before manufacturing activities begin.

Oversee successful execution of manufacturing batch records, work instructions, and SOPs with a focus on right first time performance.

Maintain schedule adherence and cycle time expectations by identifying risks early and escalating impacts to Manufacturing leadership.

Lead daily communication to team members, including shift huddles, Tier 1 and Tier 2 meetings, and shift handover expectations.

Own or support the Tier 2 manufacturing performance review process, cross-functional board, metrics, action tracking, and escalation to Tier 3 and site leadership when required.

Support SQDCP or SQSCP communication by reviewing safety, quality, delivery or supply, cost, and people performance.

Ensure production updates, shift notes, and action items are clear, accurate, complete, timely, and inspection ready.

Partner with Quality, MSAT, Process Development, Supply Chain, EHS, and Facilities and Engineering to resolve issues and maintain production flow.

Create, own, or support deviation, non-conformance, OOS, CAPA, change control, and manufacturing-related quality records as assigned.

Review and approve manufacturing documentation as assigned, including SOPs, batch records, logbooks, training materials, and operational procedures.

Lead implementation of new processes, technology transfer activities, engineering runs, process changes, and digital manufacturing tools within the manufacturing area.

Coach, mentor, and develop Associate Specialists, Manufacturing Specialists, and Lead Cell Therapy Specialists.

Conduct regular one-on-one meetings and maintain development plans for direct reports.

Conduct performance discussions, support career development, and address performance concerns in partnership with HR and leadership.

Identify and develop future Lead Specialists and Manufacturing leaders through coaching, delegation, stretch assignments, and succession planning.

Support workforce planning, staffing models, capacity planning, and shift structure recommendations to meet current and future demand.

Identify and lead continuous improvement initiatives that improve safety, quality, schedule adherence, throughput, cost awareness, and team effectiveness.

Support audit and inspection readiness by ensuring the team maintains compliant behaviors, documentation, cleanroom discipline, and visual inspection readiness.

Control expenses within area of influence, including overtime, supplies, consumables, and resource utilization.

Perform additional responsibilities and project-based assignments as needed to support Manufacturing operations and business objectives.

You Are Accountable For

Safe, compliant, and right first time execution of assigned manufacturing operations.

Delivery of production schedules and patient supply commitments.

Effective management of people, materials, equipment, documentation, electronic systems, and cleanroom readiness.

Timely escalation of safety, quality, schedule, staffing, material, equipment, facility, or patient supply risks.

Effective Tier 1/Tier 2 communication, shift handover, and cross-functional escalation.

Reliable evening/overnight coverage for late APH receipt and execution, including protection of downstream process timing and controlled handover to day-shift Manufacturing leadership.

Effective performance and relationship management of the GMP facility cleaning/sanitization vendor and gowning vendor, including timely action closure and escalation of service, quality, safety, or readiness risks.

Manufacturing team performance, development, engagement, accountability, and one-on-one cadence.

Deviation support, CAPA execution, quality record management, and timely closure of assigned manufacturing actions.

Maintaining visual inspection qualification coverage and visual inspection readiness within assigned area.

Maintaining inspection readiness and GMP discipline within assigned area.

Driving continuous improvement and operational excellence within the team.

Building leadership capability and maintaining succession readiness within the team.

Building a culture of safety, quality, teamwork, accountability, inclusion, and patient focus.

Required Qualifications

• •Minimum of a High School Diploma with significant relevant experience
• •Minimum of 8-10 years of relevant experience and 3-5 years of leadership experience.

Experience leading teams in a GMP manufacturing environment.

Strong understanding of cGMP, SOPs, batch records, cleanroom operations, safety requirements, quality systems, and regulated manufacturing environments.

Experience with cell therapy, biologics, pharmaceutical, biotech, or vector manufacturing.

Demonstrated ability to manage daily operations, staffing, scheduling, resource management, workload management, and production readiness.

Strong people leadership, coaching, communication, organization, time management, and decision-making skills.