Manufacturing Manager

AstraZeneca•Los Angeles, CA

About The Position

The Manufacturing Manager - Swing Shift leads evening and overnight manufacturing operations supporting TCR T, CAR T, and allogeneic cell therapy programs. The role translates manufacturing strategy into controlled execution, with accountability for safe, compliant, reliable, and right-first-time production; patient supply and schedule commitments; staffing and resource management; floor readiness; late APH receipt and processing; and effective shift handover. The manager provides substantial on-floor leadership, coaches and develops the team, manages Tier 1 and Tier 2 performance processes, and coordinates after-hours support and escalation across functions. The manager is the Manufacturing liaison and primary point of contact for the GMP facility cleaning and sanitization vendor and gowning vendor. Responsibilities include coordinating vendor schedules, staffing and site access, reviewing performance and KPIs, tracking actions, escalating issues, and ensuring services support production windows, contamination control, GMP readiness, and next-shift readiness. The role partners with Quality, MSAT, Process Development, Supply Chain, EHS, Facilities and Engineering, and other functions to maintain production flow and resolve issues. It supports quality records and investigations, reviews manufacturing documentation as assigned, leads or supports process and technology changes, maintains inspection readiness, and drives continuous improvement. The manager also conducts one-on-ones and performance discussions, maintains development plans, supports workforce and capacity planning, and develops future team leaders. The position is assigned to the Manufacturing Swing Shift, nominally 1700-0330 on Sun-Wed or Wed-Sat. The schedule may require weekends, holidays, extensions, overtime, or alternate coverage based on patient demand, APH arrival timing, manufacturing schedules, and business needs. The role may require cleanroom gowning and work around automated cell-processing, cell-expansion, and filling equipment; human blood products or other biological materials; strong magnets; and vapor-phase liquid nitrogen or other cryogenic materials.

Requirements

High school diploma or equivalent with significant relevant experience.
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 in 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.
Ability to troubleshoot operational issues and assess risk to product, people, plant, and patient supply.
Ability to work effectively in a fast-paced, complex, and changing manufacturing environment.
Ability to collaborate and influence across Manufacturing, Quality, MSAT, Process Development, Supply Chain, EHS, and Facilities and Engineering.
Working knowledge of FDP visual inspection qualification coverage and defect escalation processes, as applicable.
Ability to work in a cleanroom environment and gown as needed.
Ability to stand, walk, or sit for extended periods and support manufacturing operations on the floor for moderate to extended periods.
Ability to work the assigned Swing Shift and provide additional coverage, including weekends, holidays, schedule extensions, overtime, or alternate coverage as business needs require.
Must follow safety, contamination-control, gowning, documentation, and cGMP requirements.

Nice To Haves

Bachelor's or master's degree in science, engineering, life sciences, business, or a related discipline.
Experience in cell therapy manufacturing.
Experience supporting clinical or commercial manufacturing, technology transfer, engineering runs, process validation readiness, or commercial readiness.
Prior supervisory or people-management experience.
Experience leading deviation investigations, CAPAs, change controls, SOP revisions, batch-record improvements, or inspection-readiness activities.
Experience with electronic batch records, MES, inventory systems, quality-management systems, or scheduling systems.
Experience implementing Lean, 5S, visual management, standard work, Tier 2 boards, problem solving, or other operational excellence tools.
Experience developing Leads or front-line leaders.
Experience managing third-party vendors, contractors, or service providers in a GMP, cleanroom, pharmaceutical, biotechnology, or similarly regulated environment.
Experience supporting second-shift, swing-shift, night-shift, or other extended-hours regulated manufacturing operations.

Responsibilities

Lead daily manufacturing operations for an assigned shift, area, or functional team.
Manage Swing Shift staffing, scheduling, assignments, workload, production readiness, and resource use to meet patient supply demand.
Coordinate after-hours support and escalate issues with Quality, MSAT, QCA, QCM, Supply Chain, EHS, Facilities and Engineering, and other support functions.
Serve as Manufacturing liaison and primary point of contact for the GMP facility cleaning and sanitization vendor and gowning vendor; coordinate schedules, staffing, site access, KPI reviews, action tracking, issue escalation, and follow-up.
Ensure cleaning, sanitization, room turnover, and gowning services align with production windows and next-shift readiness; escalate service failures that could affect contamination control, GMP readiness, or patient supply.
Provide on-floor oversight and coaching focused on safety, quality, and execution discipline.
Ensure manufacturing activities are executed safely, compliantly, and according to approved procedures.
Ensure personnel, materials, equipment, documentation, electronic systems, and cleanroom areas are ready before manufacturing begins.
Oversee execution of batch records, work instructions, and SOPs, emphasizing right-first-time performance.
Maintain schedule adherence and cycle-time expectations by identifying risks and escalating impacts to Manufacturing leadership.
Lead team communications, shift huddles, Tier 1 and Tier 2 meetings, and shift handovers; maintain clear, accurate, timely, complete, and inspection-ready updates and action items.
Own or support Tier 2 performance reviews, cross-functional boards, metrics, action tracking, and escalation to Tier 3 and site leadership as required.
Support SQDCP or SQSCP communications covering safety, quality, delivery or supply, cost, and people performance.
Partner with cross-functional teams to resolve issues and maintain production flow.
Create, own, or support deviation, non-conformance, OOS, CAPA, change-control, and other 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 transfers, engineering runs, process changes, and digital manufacturing tools in the manufacturing area.
Coach, mentor, and develop Associate Specialists, Manufacturing Specialists, and Lead Cell Therapy Specialists; conduct regular one-on-ones and maintain development plans for direct reports.
Conduct performance discussions, support career development, and address performance concerns in partnership with HR and leadership.
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.
Identify and lead continuous improvement initiatives to improve safety, quality, schedule adherence, throughput, cost awareness, and team effectiveness.
Support audit and inspection readiness through compliant behaviors, documentation, cleanroom discipline, and visual inspection readiness.
Control expenses within the area of influence, including overtime, supplies, consumables, and resource utilization.
Maintain visual inspection qualification coverage and readiness within the assigned area.
Perform additional responsibilities and project assignments as needed to support manufacturing operations and business objectives.