Fred Schempp Email & Phone Number

Lawrence Township, Nj, Us

- Managing the cell therapy manufacturing process Expansion for the Abecma product line which includes six Managers and a processing staff up to 90 employees.- Leading the manufacturing team which includes a diverse group of 70% permanent and 30% full-time contingent staff that comprises the seven processing days of cell expansion for the treatment of multiple myeloma by genetically modifying the cancer cells using the patient’s own white blood cells.- Utilizing continuous improvement methodology to streamline processes and implement lean practices and methods found in the LSS toolbox. Led or participated in Kaizen, Kanban, Visual Mgmt., Tier Mgmt.- Sponsoring and leading the multiple functional Kanban improvement team (two production suites) to minimize inventory, material and production supply waste and reduce replenishment activities by creating a one-bin/two section container and ordering using an automated QR-style bar code scanner and system displayed on Kanban card.- Creating high-performance leadership teams on two alternate, seven-day, 12-hour shifts by developing sustainable, inclusive growth with my organization consisting of managers, manufacturing leads, Sr. and Assoc. production workforce. (26.3% of all processes)- Establishing excellent performance with lowest deviation result per employee by unit (one avoidable deviations per 266 processes) and zero injuries, accidents or near misses over the last year. Achieved highest production metric by process (EBR’s) based on high number of expansion batches.- Achieving high on-time performance training performance with daily work time allotted to prevent late trainings.- Support cross-training within functional area teams by ongoing training & repetition on shift to enable continuous processing.

Somerset, Nj, Us

Performed as the operations leader with responsibility for manufacturing, supply chain, planning, scheduling, training and batch record creation. I am leading a turn-a-round effort after extended downtime with quality and performance issues. The plant's productivity has made strong improvements and the plant is making great strides in improving lean culture, quality and shop floor compliance and reduction in quality records and actions. The operation has met strong sales growth in development and clinical projects preparing for expected higher demand in commercial sales. I am working with current staff to train and increase the workforce anticipating these new projects.

Troy, Mi, Us

Janssen is pharmaceutical division of Johnson & Johnson manufacturing new vaccine product Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Janssen is outsourcing manufacturing to several suppliers including Merck and Sharp Pharmaceutical Packaging companies. Janssen Research and Development (JRD), conducts research and development activities related to a wide range of human medical disorders, including mental illness, neurological disorders, anesthesia and analgesia, gastrointestinal disorders, fungal infection, HIV/AIDS, allergies and cancer.Quality Assurance Manager - Maintain oversight of the manufacturing facility for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly - Provide on the floor quality support to manufacturing during operations and critical process steps/testing- Escalate quality issues through management in order to provide client resolution- Review batch documentation provided by external manufacturing site for compliance with cGMPs, Janssen standards, and product specifications. Ensure all required testing and documentation is provided and meets release requirements.- Enter data into eLIMS- Alert Supervision of any nonconforming results, out of trend, or out of specification results- Support supply chain logistics for on time shipment from CMO to Warehouse

Kidlington, Oxford, England, Gb

Led all operations with responsibility for overall plant performance including continuous improvement, quality and safety activities. Providing safety to employees as an essential manufacturer by navigating through NJ COVID-19 executive orders with only three cleaning protocols. Lead change management to develop operations into a more flexible, adaptable organization to remain competitive.- Improved operating profit during a pandemic when sales volume was only at 76% of budget and incorporated shift gapping (6% productivity loss) by rightsizing the organization and leveraging the highest performers across all areas. Cross trained the numerous packer role between product lines and flex flowed other positions to support a lean operation while exploiting constrained resources/ operations with additional trained people.- Sponsored and supported press make-ready reduction Kaizen and executed quality 8D problem solving methodology in areas such as gluer carton defects. Led improvements in the warehouse by adopting lean concepts in put-away, picking and shipping.- Hired new employees (supervisors, skilled operators and maintenance) plus coaching up existing staff to execute for an operational turn-a-round and to build on Lean Daily management principles using 3 tiers including visual mgmt. boards and tier 2 video conferencing to assure social distancing were regular activities. At nine tier 1 stations, I applied lean thinking using area KPI’s and identifying shop floor problems where countermeasures were rolled out to resolve the issue at hand. In addition, Gemba walks, standard work, process verification, seven waste walk-a-bouts and small batch/one-piece flow were common practices by management.- Implementing new lean maintenance management system while investing in new and existing equipment using CAPEX to improve operations and increase capacity in a growing pharmaceuticals and cosmetics component market.

Allentown, Pa, Us

- Served as a LSS resource providing lean leadership and managing projects. I often interfaced with pharmaceutical and biologic external manufacturing clients including engineers, quality and operational representatives. I reported to both VP’s of Operations and Sr. Director for Operational Excellence.- Led value stream mapping projects currently including improvement of end-to-end lead times from PO to invoice for contract packaging product value streams (project lead and facilitator for Alkermes, Biogen, Bristol-Myers Squibb). Improved key supplier/customer inputs and removing waste from the process. In addition, implemented a transformation plan for internal VSM projects which expects to reduce total lead time from 182 to 90 days within the Inventory Destruction Request (IDR) process.- Launched a lean project to reduce batch record review (BRR) cycle time (CT) for a dept. of 8 people reviewing 250 batch records per month. I provided the data and analysis for BRR process steps and supported the Quality Assurance improvement team to execute strategies, processes and training to reduce overall CT. Currently, mean CT has been reduce from 7 to 3 days (w/o dev.)- Provided coaching and sponsorship to tens of project leaders for 14 Tactical A3’s in all areas of the organization including Project Mgmt., Purchasing, Incoming Inspection, Supply Chain, Production, QA on the Floor and Batch Record Review.- Supported OPEX Sr. Dir. in launch of Hoshin Kanri Planning rolled out throughout the organization from leadership to the prod. floor. Also Led company-wide overtime cost reduction initiative; improved accuracy of shop floor production data collection.- Implemented the Sharp Edge visual management boards in all production sites to communicate tactical A3’s, metrics, continuous improvements & cost reduction projects throughout the Sharp Commercial Division. Contributor to Lean Newsletter.

Allentown, Pa, Us

Served as lean leader instilling lean learning throughout the plant from project management, planning & scheduling, labeling, materials management and solid dose manufacturing and packaging. Performed projects for the Sr. Director, Operations.- Reduced operating costs by 8% through eliminating waste, streamlining SOPs, standardizing and transferring work to the most efficient areas. Overhauling the quality event process by leading team to reduce 4 SOPs and 10 forms to one SOP and 3 forms.- Qualified new equipment and wrote change controls including writing and executing qualifications. Wrote SOPs for new equipment and processes. Improved returns and discard processes by reviewing current process with lead technicians and cutting out waste.- Assisted and supported contract clients with manufacturing and packaging projects and efficient processes.- Implemented a daily, plant-wide production order process with job status boards to manage drug and comp. receipts, incoming inspection, quality assurance approval, material staging plus other activities through operations for production readiness.- Performed lean and six-sigma projects with the purpose of increasing productivity, reducing costs and eliminating waste.- Formed a process mapping team to streamline batch record handling and throughput in the organization so the batch record was approved and ready for production.- Created an “Obeya” room or “War” with KPI, metrics, project plans, activity calendars, problems solving tools, etc. and trained and modeled how to lead for the division leaders and operational managers.

Allentown, Pa, Us

Managed a 35-person organization with two production supervisors and a planner/scheduler reporting to me in a cGMP contract clinical manufacturing and packaging operation achieving performance KPI’s such as Safety, Waste, OEE and OTIF goals.- Improved planning and scheduling of clinical manufacturing and packaging orders from contract order through mfg. (throughput has increased 30% and on-time delivery has improved by 22% over six months.- Implemented lean six-sigma projects throughout the organization; implemented operational and process improvements in manufacturing and packaging.- Investigated & wrote deviation investigations and implemented CAPAs in the operation to close out a backlog of late deviations.- Introduced tier management system in the plant concentrating on manufacturing and packaging

Managed large sterile supply operation that washed qualified stainless steel parts and assembled equipment and glassware and sterilized them for sterile manufacturing for a portfolio of vaccine products in a large, global pharmaceutical and biologics company. - Developed engagement, inclusion and safety culture through coaching, IPT Tier process and GMP shop floor management.- Improved performance and safety through measurement of key department metrics (no lost time injuries over 2.5 years).- Zero regulatory observations during inspections throughout years 2011, 2012 and 2013.- Significantly reduced deviation investigations in dept. by over 20% in each of two years by improving SOP adherence & training.- Lowered labor costs by managing OT hrs. to near zero over a 12-mo. period by increasing people productivity & equip. uptime.- Improved productivity at qualified washer (from 3 to 4 batch loads per shift) increasing throughput by reducing labor & rework.- Significantly increased Right First Time Sterilization Record Accuracy goal (92.1% actual vs. 90.0% target). Prior year actual 78%.- Achieved zero customer delivery delays except through direct equipment downtime. Schedule adherence improved 15% despite high equipment downtime and maintenance requirements.

Coordinated with formulators, supply planners, operations, and mechanical services to create and manage manufacturing schedules for three research and manufacturing partners (PR&D, PCT and SDP Process). Pilot plant gatekeeper leading daily and weekly production scheduling meetings to discuss and plan upcoming campaigns. Provided project management for manufacturing teams.- Increased clinical batch throughput 147% utilizing full features of scheduling software, streamlining scheduling processes, load balancing process equipment start times and scheduling preventative and corrective maintenance plans.- Reduced expected outsourcing costs by $5.3MM in 2008 and $2.2MM in 2009 by increasing operation's productivity and manufacturing capacity. Furthermore, avoided huge delays in clinical supply to clinics with no delayed studies. Serviced mfg’ing partners by scheduling and meeting requested start dates within two-week period while operation's on-time equipment metric remained well above 98% goal; completed work safely with no injuries or environmental incidents over three-year period.- Presented and implemented comprehensive list of improvements and recommendations in newly created SDP Planning and Scheduling function. - Analyzed position, responsibilities and requirements and implemented proposed solutions aimed at improving production readiness, achieving on-time delivery by 18% and enhancing communication of project management with internal customers.- Redefined SDP pilot plant clinical batch full capacity by 133% (300 to 400) by demonstrating in one year an increase from 225 batches to 365 batches. Sr. Management indicated pilot plant was already at capacity and at risk if demand increased. Introduced performance enhancements and established new capacity ceiling while maintaining perfect safety and environmental performance and improving quality for three straight years.

Performed process improvement/cost reductions, safety & environment compliance projects, capital projects and department KPI's and financial reporting; raw material and component inventory management between two systems (IMPACT/POMS) and physical inventory for vaccine raw materials and components. Oversaw procurement, inventory and distribution of shared process filters, manifolds and production supplies. - Served as department safety lead, Non-Conformance Lead Investigator for quality improvement projects. - Provided coverage for Manager and, in July 2007, assumed additional responsibilities after Manager’s position was consolidated.- Achieved five straight years of near- flawless manufacturing, quality and service as productivity increased and on-time deliveries were 100%. Department quality and safety records were outstanding, with few minor human errors and injuries during period.- Recognized by Sr. Dir. with Division / Staff Area Award (2006) for implementing innovative approach to providing manufacturing supplies to customers and exceeding expectations by using Pick & Pack concept. Made available common supplies to sites 24/7.- Managed department capital project implementation and mechanical services improvements and repairs. - Rolled out lean concepts including department planning and assignment tool which utilized concept of visual workplace which improved department productivity by 27%.

Managed 1st shift Vaccine Weigh & Dispense operation and provided raw materials and supplies to most of site’s vaccine manufacturing operations. Provided materials management services, including precision weighments of raw materials and chemicals and provided receiving, storage and distribution of materials to BTM production areas and numerous other sites. Purchased production and cleaning supplies for internal customers and provided receiving, inventorying and distribution services.- Improved customer on-time delivery from 95% (2001) to 99.9% (2002) and 100% for next five years. - Reduced overtime from 26.7% (2001) to 7.7% (2005), during period of high turnover.- Significantly enhanced quality and safety performance with 0 errors and one lost time injury in three years.- Increased overall department performance metric by reducing hours/weighment by 22.2% in 2002 and by 19.0% in 2003 Overall productivity improvement of 45.5% over three years.- Achieved 2004 Customer Satisfaction Survey result by attaining high score of 4.52 out of 5.00; tracking higher for 3 years.

I supervised a Graphic Services production department shift including press, pre-press and bindery with a workforce of 35 shift employees represented by three bargaining units. Responsibilities include all aspects of production, training, quality, safety; service levels and serving as backup system administrator of the department’s stand-alone printing management software system. I also performed the following routine tasks: work orders through Maximo, Payroll interface via SmarTIME, Preventative Maintenance through the Electronic PM software, purchasing and approving of supplies through SAP, writing and revising SOPs, completing APRs as needed and maintaining or disposing of department assets.Accomplishments:* Safety - No Lost Time Accidents for over two years.* Financial Performance – produced well over budgeted levels as a department for the three years in position.* Assisted in conversion from non-Y2K compliance accounting system to integrated, printing/financial management software.* Coordinated internal component shipping and maintained record retention; improved Sundry Shipping Order Manifest system.* Developed print order job closing process and provided training to users; conducted system auditing for aging print orders and closing them out for billing.

Bs, Industrial Engineering

Pursuant Of Mba, Business Administration And Management, General