| Location | Germantown, MD |
This job is posted on behalf of Clinical Dynamix, Inc. by Top Echelon.
The Senior Manufacturing & Facilities Specialist is a hands-on role that executes GMP cell therapy manufacturing while keeping the facility, utilities and equipment in a continuous state of control, so patient batches are made safely, on time and in compliance.
You will work in the cleanroom alongside the manufacturing team, performing aseptic processing on patient batches, and own the day-to-day running of cleanrooms, critical systems and manufacturing equipment. You will partner closely with Manufacturing, Quality Assurance, Quality Control, Validation and MSAT, and act as the site's facilities and equipment lead during regulatory inspections and client audits. There are no direct reports at this time.
As an early member of a start-up, you will wear multiple hats across manufacturing, facilities, equipment, materials and compliance. Priorities will shift with the clinical schedule, so you will need to judge what matters most, pivot quickly and keep GMP standards intact while doing it.
You will own day-to-day manufacturing execution and operations, reporting status and risks to Technical Operations and cross-functional partners.. Core processes are established, so the focus is on driving process improvement across Operations and closing SOP gaps where they exist. We need someone self-motivated who leads by example and takes ownership without waiting to be asked.
• Execute cell therapy manufacturing processes in Grade A/B cleanrooms per batch records and SOPs (e.g. apheresis receipt, cell selection, activation, transduction, expansion, harvest, formulation, fill and cryopreservation).
• Perform aseptic manipulations in biosafety cabinets and operate closed and semi-closed processing systems.
• Complete batch records, logbooks and equipment records contemporaneously and right-first-time.
• Maintain chain of identity and chain of custody for patient material from receipt through release and shipment.
• Execute aseptic process simulations (media fills) and maintain gowning qualification.
• Perform in-process sampling and support line clearance, room release and changeover.
• Own the Manufacturing department: production schedule, batch readiness, right-first-time performance and inspection readiness.
• Represent Manufacturing and Technical Operations in cross-functional team and leadership meetings, reporting status, risks and resource needs.
• Run routine operations of the GMP cell therapy facility to support clinical manufacturing schedules.
• Plan and coordinate facility shutdowns, maintenance windows and changeovers with QA to minimize impact on patient batches.
• Track and report operational KPIs: equipment uptime, PM/calibration compliance, environmental excursions, deviation and CAPA closure.
• Manage service contracts and spares inventory and provide input to operations budgets and capital requests.
• Maintain ISO 5–8 (Grade A–D) cleanrooms, gowning areas and controlled spaces in a qualified, inspection-ready state.
• Oversee critical utilities and building systems: HVAC/AHUs, HEPA filtration, pressure cascades, BMS/EMS, LN2 supply, CO2, clean compressed gases, WFI/purified water where applicable.
• Manage cleaning and disinfection programs and support environmental monitoring trending with QC.
• Manage contractors and vendors for maintenance, pest control, waste, security and cleaning, ensuring GMP-compliant work practices.
• Lead facility expansions, fit-outs and modifications, from user requirements through commissioning and handover.
• Own the lifecycle of manufacturing and support equipment: biosafety cabinets, incubators, controlled-rate freezers (CRFs), LN2 storage and vapour-phase dewars, cell processing systems (e.g. Rotea, CT-5, CliniMACS Prodigy, Sepax, Lovo, Xuri/WAVE), centrifuges, cold-chain units.
• Run the preventive maintenance and calibration program in the CMMS (e.g. Blue Mountain, Maximo), keeping it on schedule.
• Support equipment qualification (URS, FAT/SAT, IQ/OQ/PQ) and periodic requalification with Validation.
• Manage alarm monitoring and 24/7 on-call response for critical equipment and storage.
• Lead troubleshooting and root-cause analysis for equipment failures.
• Ensure operations comply with 21 CFR Parts 210, 211 and 1271, EU GMP (including Annex 1 and Annex 2), and ICH Q9/Q10.
• Author and review SOPs, work instructions, change controls, deviations, investigations and CAPAs.
• Act as SME for facilities and equipment during FDA, EMA/MHRA and client inspections and audits.
• Maintain data integrity (ALCOA+) across logbooks, CMMS and monitoring systems.
• Lead process improvement across Operations: identify inefficiencies, propose solutions and see them through change control to implementation.
• Review and improve existing SOPs, batch records and work instructions; author new SOPs where gaps exist.
• Improve equipment reliability, scheduling and right-first-time execution using data from deviations, KPIs and batch performance.
• Train manufacturing staff on equipment operation, facility procedures and GMP practices.
• Promote a strong safety culture, including biosafety, cryogen handling and LN2 oxygen-depletion controls.
• Bachelor's degree in Engineering, Life Sciences or a related field, or equivalent experience.
• 7–10 years of GMP manufacturing experience, ideally all in cell therapy, with a minimum of 5 years of hands-on cell therapy manufacturing. Facilities/equipment experience is valued but secondary to execution.
• 3+ years supporting facilities and/or equipment in a GMP cleanroom environment.
• Well versed in cell therapy manufacturing equipment, including the Rotea and CT-5 platforms used on site, biosafety cabinets, other cell processing and selection systems (e.g. CliniMACS Prodigy, Sepax, Lovo), bioreactors (e.g. Xuri/WAVE, G-Rex), controlled-rate freezers (CRFs), LN2 storage and cell counters, with hands-on aseptic execution in Grade A/B cleanrooms.
• Working knowledge of FDA and EU GMP regulations, including Annex 1 and 21 CFR 1271.
• Hands-on experience with equipment qualification, CMMS-based maintenance and calibration, and change control.
• Track record of supporting regulatory inspections.
• Experience in a start-up, developing cell or advanced-therapy products (experience with allogeneic or other non-standard cell products a plus).
• Experience with cryogenic storage and cold chain for patient material (chain of identity / chain of custody).
• Facility start-up, expansion or tech-transfer experience.
• Familiarity with BMS/EMS platforms (e.g. Siemens, Rees, Vaisala) and electronic QMS (e.g. Veeva, MasterControl).
• Lean, Six Sigma or similar continuous improvement credentials, with examples of improvements delivered.
• Leadership: owns day-to-day manufacturing execution, sets the standard for GMP execution and represents the function confidently in cross-functional settings, without needing formal authority.
• Self-motivation: identifies what needs doing and drives it to completion with minimal direction.
• Prioritization and adaptability: balances competing demands across manufacturing, facilities and compliance, and re-plans quickly when priorities change.
• Continuous improvement: challenges existing ways of working and turns ideas into measurable process gains.
• Start-up mindset: comfortable with ambiguity, wears multiple hats and takes on whatever the site needs.
• Compliance mindset: makes decisions that hold up under inspection and protects patient safety first.
• Technical depth: understands how cleanroom, utility and equipment performance affect cell product quality.
• Ownership: keeps critical systems running and escalates early when they are at risk.
• Collaboration: works across Manufacturing, QA, QC, Validation, MSAT and vendors.
• Clear communication: writes precise GMP documentation and briefs leadership on risk and status.
• Fully on-site role in Germantown, MD, with regular cleanroom gowning (up to Grade B).
• Participation in an on-call rota for critical alarms, including occasional evenings and weekends.
• Work around cryogens, biological materials (BSL-2) and laboratory chemicals with appropriate PPE.
• Ability to lift up to [25 lb / 11 kg] and stand for extended periods.