The Senior CAR-T Project Manager is accountable to lead medium to large scale projects for a multi-product Chimeric Antigen Receptor T-cell (CAR-T) manufacturing facility. This role will lead cross-functional teams in a highly matrixed environment, and will be responsible for facilitating meetings, developing detailed project plans, driving decisions and commitments, and ensuring that issues are escalated to the manufacturing Site Leadership Team when required. Types of projects within the portfolio include, facility and capital expansion, tech transfers, manufacturing process changes, CAPAs and risk remediation projects, and projects that have been communicated as commitments to regulatory health agencies. This will work with other project management teams and subject matter experts from various functions such as Manufacturing, Operational Excellence, Supply Chain, Manufacturing Science and Technology (MS&T), Quality Assurance, Quality Control, Process Development, Facilities Engineering, IT, EHS, Finance, and Regulatory.

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•This role will work well with Engineering, Reliability, Quality, and HSES• Develops and execute the maintenance strategy, maintenance and reliability work plans, local capital projects, and strategic plans for system overhauls and upgrades• Collaborates effectively across functional groups• Partners with Reliability organization to determine supporting software utilization and methods for effectiveness• Exhibits strong leadership skills to motivate and develop a team consisting of Maintenance and I&E Technicians, Maintenance Planner, Material Planner, and outside contractors• Ensures production equipment, facilities, utilities, and grounds are operating reliably, efficiently, and in compliance with all safety guidelines and government regulations• Oversees the development, revision, review, and approval of all maintenance work instructions and standard operating procedures• Develops, sets, tracks, and reports on maintenance KPIs and Metrics and analyzes performance as means to drive operational improvement• Performs root cause analysis• Utilizes new technology, specialized equipment and/or tools, and Lean Manufacturing principles and processes to improve maintenance performance• Supports HSES procedures, directives, and Management of Change process• Manages maintenance spending• Develops strategy for stores/critical spares inventory• Executes administrative activities (Payroll, Purchasing, HR)

Project Manager with strong work ethic, teamwork skills, and leadership capabilities for managing multiple client projects and teams for GLP/GMP sites. Experience creating standard operating procedures (SOPs), IOQ/PQs, URSs, assisting upper management with meeting aggressive timelines / budgetary goals, and working with Quality Assurance to meet FDA requirements for GxP environments.

The Maintenance Manager oversees production maintenance activities across three shifts and the AWS Shift, including AWS and Shift supervisors, planner-scheduler, maintenance and changeover technicians, parts room staff, and dispatchers to ensure maximum operating efficiency and ensuring compliance with all Safety and Environmental requirements. Additionally, this position reports to the Director and will be engaged in developing and implementing timelines, parts, and cost control measures, and have a working knowledge of financial administration in areas of capital expenditures and budget management, preventative maintenance programs, safety and quality programs as it relates to equipment and production efficiency to help achieve departmental goals.

The Asset Maintenance Engineer provide oversight for the asset care program related to equipment, systems and utilities to ensure reliable operation, appropriate levels of maintenance and minimal downtime.Responsibilities:• Lead the overall asset (equipment) care strategy for the site through the core equipment sup-port functions (Equipment Experts, Facility Engineers, Automation Engineers). • Lead reliability life cycle management of equipment, including design (new equipment), operation and maintenance. This includes identifying and implementing of site and global engineering best practice. • KPI Monthly Reports (both site and global)• Analyze equipment failures, trends and implement appropriate CAPA actions to address.• Implement optimal levels of maintenance to ensure equipment reliability. • Management of site CMMS system--Blue Mountain Regulatory Asset Management (BMRAM) • Maintain appropriate levels of spare and repair parts for all critical equipment utilizing BMRAM inventory.• Purchase and track all parts required for planned maintenance and critical spare parts for on demand maintenance events. • Participate in maintenance planning activities to minimize disruption to production. Coordinate scheduled activities with E&F and Equipment Owners • Support capital investments concerning production facilities, master planning and site infra-structure with adherence to Novartis guidelines. •Supports/Prepares/Executes Engineering & Facility audits • Ensure that all (internal, regulatory and statutory) QA, HSE and NTO relevant guidelines, directives and processes are adhered to. • Support internal and external auditing activities. • Provide technical support to operations and support personnel

Responsible for Cell and Gene equipment oversight for the entire life cycle of equipment, ranging from concept, design, transfer into production, maintenance, upgrades, retirement and disposition. Responsibilities extend to equipment across all departments onsite, including GMP Manufacturing, Quality Testing Laboratories, and Development Laboratories. Will work to minimize equipment downtime and ensure future equipment design is robust and reliable.

Oversee all installation, repair, and upkeep operations of the company's facilities, processing, and packaging operations.• An active member of the site leadership team driving an OEE focused culture• Develop maintenance procedures and ensure implementation• Carry out inspections of the facilities to identify and resolve issues• Plan and oversee all repair and installation activities• Allocate workload and supervise upkeep staff• Monitor equipment inventory and place orders when necessary• Monitor expenses and control the budget for maintenance• Manage relationships with contractors and service providers• Keep maintenance logs and report on daily activities• Ensure compliance with all health and safety policies

Responsible for leading and directing Technical Associates in the daily support of the Manufacturing Operation. Ensure all direct reports are always 100% trained in required procedures for the execution of their role. Provide leadership, teaching, coaching, and mentoring to Technical Associates and Operations Associates to better achieve tactical and strategic goals.• As an SAP_PM power user, ensured all technicians correctly enter and sign off on their work in a timely fashion.• Led team to develop and implement skills in detecting and resolving equipment-related process constraints, reducing our time of implementation by 20%. • Participated as Subject Matter Expert in over ten successfully implemented equipment-related projects over two years, seeing increased operability of xx% (or decreased downtime, or increased reliability,etc) • Lead equipment-related continuous improvement projects while providing technical training to Technical Associates, resulting in successful alignment of 5S, standard work, and Single Minute Exchange of Dies (SMED) events increasing Overall Equipment Effectiveness (OEE).• Led cross-functional team to redesign technician training curriculum, resulting in streamlined training matrix focusing on operational support and the elimination of cross training gaps. Improved training metrics by 75% in six months.

Responsible for analyzing, diagnosing, developing and implementing packaging line operations process improvements. Responsible for developing all direct reports by implementing a robust training program.• As SME, Tier Board Coach, Trained Trainer, PPI Team Facilitator, and PPI Process Manager successfully implemented 5S, Standard Work, SMED, PPI and TQM initiatives.• Participated in daily management review boards, and as needed, to lead the efforts to troubleshoot production/process issues and provide cost effective, technically correct solutions to these issues.• Selected to represent maintenance engineering as an active member of the PPI Steering Committee

Responsible for leading teams consisting of junior calibration engineers and third party service contractors to perform scheduled and unscheduled facility/process equipment calibrations.• Responsible and accountable for understanding the process and business impact of instrumentation failures and to analyze, diagnose and quickly implement solutions to minimize those failures.• Responsible for providing accurate and compelling business cases for instrumentation improvements to existing equipment installations.• Accountable for all documentation regarding Instrument Out of Tolerance and deviation issues and for specifying new and replacement instrumentation where needed to resolve these issues.• Responsible author for all I&C SOP’s.• Selected as Blue Mountain “Regulatory Asset Manager” and “CALMAN” administrator.

Responsible for the calibration of all instrumentation and for performing additional, more complex measurement uncertainty analysis when needed.• Determine methods and procedures on new instrumentation and provided recommendations for implementation.• Authoring of SOP’s• Reviewed documentation submitted by calibration technicians to ensure that accurate, concise documentation is submitted and meets all of the requirements of cGMP's and internal SOP.• Assisted Departmental Manager with all training.• Directly guided other technicians to ensure compliance with cGMP's and (SOP's).• As an active member of Safety Committee, successfully led and implemented OHSAS 18001 standards within the facility.• Led all NCR (nonconformance reports) investigations and as well as FMEA analysis• Successfully implement Six Sigma strategies as part of company’s Total Quality initiatives.

Primarily responsible for the calibration and preventive maintenance of process equipment as well as maintaining accurate records of work performed.• Regularly required to perform all troubleshooting and repairs of equipment, including, but not limited to, Siemens S7and Allen Bradley PLC’s, in a prompt and timely manner.• Ensured all Standard Operating Procedures and cGMP standards were met or exceeded to ensure equipment compliance.

Responsible for performing maintenance and installation of equipment in a sterile production environment.• SME on Siemens S7, Allen Bradley, GE, and Direct Logic PLC’s. Troubleshooting input and output signals.• Selected to assist in writing Standard Operating Procedures for equipment based on my experience and industry knowledge.• Worked on multiple projects to upgrade equipment, improving the manufacturing process and increasing reliability while reducing changeover times and unplanned downtime.

Responsible for installing, qualifying, repairing and maintaining processing equipment used in the pharmaceutical industry. Performed factory acceptance tests and commissioning on equipment throughout North America and Europe. Managed third party contractors to ensure proper installation of equipment. • Created and scheduled preventive maintenance schedules and programs, generating additional revenue while saving customers on equipment repairs and service.• Assisted Project Manager to ensure projects were completed on time and within budget. • Worked closely with customers to assist with the installation, operation and process qualification of their equipment, ensuring it met all regulatory standards and requirements as well as the customer’s expectations.

Responsible for installing and repairing chemical dispensing systems on commercial dishwashers, laundry machines, and swimming pools. Ensuring customer satisfaction with work performed and provided after sales assistance.

Responsible for installing, diagnosing, repairing, and replacing customer equipment in a timely and customer-focused manner. Became proficient at troubleshooting electrical, mechanical and software related issues, saving our customers both time and money.

Responsible to plan work schedules and assign duties to maintain adequate staff for effective performance of activities and response to fluctuating workloads. Managed and facilitated solutions to all work-related problems within the driver fleet. Collaborated with maintenance team to ensure all vehicles were inspected and maintained to ensure the safety of all drivers. Responsible for timely completion and submission of payroll as well as for reporting all DOT violations.

• Review work orders and blueprints to ensure work is performed according to specifications.• Complete production reports to communicate team production level to management.• Determine work assignments and procedures.• Maintain production equipment and machinery.• Provide assistance in the production of wiring assemblies.• Supervise assemblers and train employees on job procedures.• Inspect, operate, and test completed products to verify functioning, machine capabilities, or conformance to customer specifications.• Position or align components for assembly, manually or using hoists.• Set and verify parts clearances.• Rework, repair, or replace damaged parts or assemblies.• Read and interpret assembly blueprints or specifications manuals and plan assembly or building operations.• Maintain and lubricate parts or components.• Assemble systems of gears by aligning and meshing gears in gearboxes.• Verify conformance of parts to stock lists or blueprints, using measuring instruments, such as calipers, gauges, or micrometers.• Fasten or install piping, fixtures, or wiring and electrical components to form assemblies or subassemblies, using hand tools, rivet guns, or welding equipment.• Remove rough spots and smooth surfaces to fit, trim, or clean parts, using hand tools or power tools

• Disassemble machinery or equipment to remove parts and make repairs. (vacuum induction furnaces)• Repair or replace broken or malfunctioning components of machinery or equipment, including the rebuilding of hydraulic and pneumatic valves and cylinders.• Repair or maintain the operating condition of industrial production or processing machinery or equipment.• Examine parts for defects, such as breakage or excessive wear.• Reassemble equipment after completion of inspections, testing, or repairs.• Observe and test the operation of machinery or equipment to diagnose malfunctions, using voltmeters or other testing devices.• Operate newly repaired machinery or equipment to verify the adequacy of repairs.• Clean, lubricate, or adjust parts, equipment, or machinery.• Analyze test results, machine error messages, or information obtained from operators to diagnose equipment problems.• Record repairs and maintenance performed.• Fabricate new productions equipment from blueprints/drawings.• Perform welding and burning operations, carbon arc air-gauging, oxy-acetylene burning and welding, stick and MIG welding.

• Examine systems to locate problems, such as loose connections or broken insulation.• Test backup batteries, keypad programming, sirens, and all security features in order to ensure proper functioning, and to diagnose malfunctions.• Mount and fasten control panels, door and window contacts, sensors, or video cameras and attach electrical and telephone wiring to connect components.• Install, maintain, or repair security systems, alarm devices, or related equipment, following blueprints of electrical layouts and building plans.• Feed cables through access holes, roof spaces, and cavity walls to reach fixture outlets; then position and terminate cables, wires and strapping.• Inspect installation sites and study work orders, building plans, and installation manuals to determine materials requirements and installation procedures.• Adjust sensitivity of units, based on room structures and manufacturers' recommendations, using programming keypads.• Test and repair circuits and sensors, following wiring and system specifications.• Drill holes for wiring in wall studs, joists, ceilings, or floors.• Demonstrate systems for customers and explain details, such as the causes and consequences of false alarms.

Installed and repaired complicated electro-mechanical equipment and various communication devices.Supervised and trained fellow shipmates.Scheduled work for crew.Maintained and monitored spare parts inventory.Maintaining and repairing interior communications systems; Preparing and interpreting blueprints, wiring diagrams and sketches; Installing and inspecting dry cell and storage batteries; Recharging wet cell batteries; Testing interior communications and gyrocompass equipment; switchboards and bell buzzer systems; Maintaining plotters and dead reckoning equipment; Maintaining and operating TV systems; Maintaining and repairing shipboard navigation equipment.