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.
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
Preferred Qualifications
Bachelor or Master degree in science, engineering, life sciences, business, or a related discipline.
Experience in cell therapy manufacturing.
Experience supporting clinical manufacturing, 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.
Key Relationships
Internal: Manufacturing Management, Manufacturing Shop Floor, Quality, MSAT, Process Development, Supply Chain, EHS, Facilities and Engineering, HR, Training, and Site Leadership as needed.
External: GMP facility cleaning and sanitization vendor, gowning vendor, and other vendors or external partners as assigned.
Working Conditions
Must be able to work in a cleanroom environment that requires gowning as needed to support operations.
Must be able to work in an office environment with computer screens and artificial overhead lighting.
Must be able to stand, walk, or sit for extended periods of time.
Must be able to support manufacturing operations on the floor for moderate to extended periods of time.
May work in classified cleanroom environments and with sophisticated automated cell processing, cell expansion, and filling equipment.
May work in areas with strong magnets or specialized manufacturing equipment.
May work in areas where human blood products or other biological materials are handled.
May work in areas with exposure to vapor phase liquid nitrogen or cryogenic materials.
This position is assigned to the Manufacturing Swing Shift, nominally 1700-0330 on Sun-Wed or Wed-Sat. The role may require weekends, holidays, schedule extensions, overtime, or alternate coverage based on patient demand, APH arrival timing, manufacturing schedule, and business need.
May be required to provide additional coverage outside the assigned Swing Shift based on manufacturing schedule and business need.
Must follow all safety, contamination control, gowning, documentation, and cGMP requirements.
General Statement
This job description describes the general nature and level of work expected for this role. It does not list every responsibility, duty, or skill required. Employees in this role may be asked to perform other job-related duties as needed to support Manufacturing operations, patient supply, site readiness, commercial readiness, and business priorities.
The annual base pay (or hourly rate of compensation) for this position ranges from $94,692.80 - 142,039.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
Closing Date 26-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
