Plant Manager, Director, Manager

FRED SCHEMPP

*** ****** *****, ********, ************ 19446

484-***-****, ***********@*******.***

https://www.linkedin.com/in/fredschempp

PLANT MANAGEMENT

Pharmaceutical Expertise Continuous Improvement Process Driven Leadership

Operations Executive with diverse experience in pharmaceutical operations (14 years with Merck; 6 years with Sharp Pharmaceutical Packaging) and pharmaceutical printed components. Expertise in plant/operations management, LSS/CI, industrial engineering, planning and scheduling, project management, supply chain/materials management, distribution/logistics, solid dose and vaccine/biologics manufacturing and serialized pharma packaging. Extensive experience as a manager for manufacturing, supply chain and maintenance in several large and medium-sized plant operations. Skilled at managing large teams and projects while improving performance and productivity through project management and Lean Six Sigma methodology.

PROFESSIONAL DEVELOPMENT & SKILLS

Plant/Operations Leadership (up to 150 employees)

Production & Capacity Planning

Lean Six Sigma (Green Belt Certified)

Supply Chain & Materials Management (CSCP Certified)

Lean Implementation, VSM, Kaizens

cGMP Shop Floor Inspections & Turnarounds

SOPs/Technical Writing

Investigating, Deviations & CAPAs

Leadership, Coaching & Change Management

Production and Capacity Planning

Project Management (Capital Planning/Implementation)

Clean Room Knowledge

Plant/Facilities Engineering & Maintenance

Internal & External Regulatory Inspections

Raw Material and Component Management

Change Controls & Equipment Qualification (IOQ/PQ)

Continuous Process & Packaging Validation (PQ/PV)

Quality Compliance/Root Cause Analysis/FMEA/8D

Concepts of Production Velocity/Throughput

Operational and Business Turnarounds

SELECT ACCOMPLISHMENTS

Improved Vaccine Manufacturing Customer OTD from 95% to 99.9% in <one year and maintained at 100% for five years (Merck)

Reduced overtime from 26.7% to 7.7% during four-year period of high turnover. (Merck)

Significantly enhanced quality and safety performance, with zero errors and one lost time injury in three years. (Merck)

Increased overall department performance metric by reducing hours/weighment by 22.2% in 2002 and by 19.0% in 2003, with overall productivity improvement of 45.5% over three years. (Merck)

Provided engineering services and project management to create state-of-the-art, high-speed distribution center. (R.R. Donnelley)

Coordinated waste reduction and run time improvement efforts with plant coordinators at eight plants across U.S. (Moore Business Forms)

PROFESSIONAL EXPERIENCE

J

Catalent Pharmaceutical, Malvern, PA July, 2021 to present

Sr. Manager, Operations

Lead the operations organization including manufacturing, supply chain, planning/scheduling, batch record creation team as well as tactical lean practices.

Resumed above budget profitability four months straight (Mar2022) after 4 months reclaiming productivity and performance lost during transition to new management team and voluntary production stoppage due to GMP and quality issues. Sponsoring several green belt and yellow belt projects and Kaizen events. Driving lean production initiatives.

Affecting a plant turn-a-around as the plant is deficient in managing expectations, increasing personal responsibility and improving quality that is inferior to other pharma operations.

Writing and approving Deviation Investigations and CAPA actions for all operations using TrackWise system.

Providing training and development to supervision to improve performance including productivity, quality, training and leadership. Building a lean culture with shared leadership principles.

Change the operation from a culture of complacency to an organization of excellent execution and continuous improvement.

Manufacturing quality has improved in the area of deviations by 20% and production performance has improved 30% in lots completed by increasing throughput through better scheduling and higher output per shift.

Johnson & Johnson - Janssen Pharmaceutical Co. contractor position through Kelly Sciences and Clinical, Horsham, PA 2021

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 supplies 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

Essentra plc (U.S. Packaging Division), Moorestown, NJ 2020 – 2021

High-volume specialty print and packaging manufacturer focused on pharmaceutical and beauty industries. Due to COVID impact the company made the decision to close the plant and consolidate operations in three facilities located in North Carolina effective May, 2021.

Plant Manager

Led all operations (up to 150 employees), with responsibility for overall plant performance, including continuous improvement, quality and safety activities. Led change management to develop operations into more flexible, adaptable organization to remain competitive.

Improved operating profit during pandemic when sales volume was only at 76% of budget. Incorporated shift gapping (6% productivity loss) by rightsizing organization and leveraging highest performers across all areas. Cross-trained numerous packer roles between product lines and flex-flowed other positions to support Lean operations 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 warehouse by adopting Lean concepts in put-away, picking and shipping.

Hired new employees (supervisors, skilled operators and maintenance) while coaching up existing staff to execute operational turnaround and to build on Lean daily management principles, using three tiers, including visual management boards and Tier 2 videoconferencing to ensure regular social distancing. Applied Lean thinking at nine Tier 1 stations, using area KPIs and identifying shop floor problems where countermeasures were rolled out to resolve issue at hand. Used Gemba walks, standard work, process verification, seven waste walkabouts and small batch/one-piece flow as common management practices.

UDG Healthcare plc (U.S. Divisions: Sharp Pharmaceutical Packaging and Clinical Services) 2013-2020

Sharp Pharmaceutical Packaging, Allentown, Pennsylvania

Global leader in contract packaging, clinical, manufacturing, and technology services; serving the top 15+ largest pharmaceutical companies.

Manager, Continuous Improvement (2015-2020)

Served as LSS resource, providing Lean leadership and managing projects. Interfaced frequently with pharmaceutical and biologic external manufacturing clients, including engineers, quality and operational representatives. Reported to both VPs 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 and Bristol Myers Squibb). Improved key supplier/customer inputs and removed waste from process. In addition, implemented transformation plan for internal VSM projects, expected to reduce total lead time from 182 to 90 days within Inventory Destruction Request (IDR) process.

Launched Lean project to reduce batch record review (BRR) cycle time (CT) for department of eight people reviewing 250 batch records per month. Provided data and analysis for BRR process steps and supported quality assurance improvement team to execute strategies, processes and training to reduce overall CT. Currently, mean CT reduced from seven to three days (w/o dev.).

Provided coaching and sponsorship to tens of project leaders for 14 tactical A3s in all areas of organization, including project management, purchasing, incoming inspection, supply chain, production, QA on floor and BRR.

Supported OPEX Sr. Director in launch of Hoshin Kanri Planning rolled out throughout organization, from leadership to production floor. Also led company-wide overtime cost reduction initiative; improved accuracy of shop floor production data collection.

Implemented Sharp Edge visual management boards in all production sites to communicate tactical A3s, metrics, continuous improvements and cost reduction projects throughout Sharp Commercial Division. Contributed to Lean Newsletter.

Sharp Clinical Services, Phoenixville, Pennsylvania (Relocated to Bethlehem, Pennsylvania)

Manager, Continuous Improvement (2014-2015)

Served as Lean leader, instilling Lean learning throughout plant, including project management, planning and scheduling, labeling, materials management and solid dose manufacturing and packaging. Performed projects for Sr. Director of Operations.

Reduced operating costs by 8% by eliminating waste, streamlining SOPs, and standardizing and transferring work to most efficient areas. Overhauled quality event process by leading team to reduce four SOPs and ten forms to one SOP and three 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.

Implemented daily, plant-wide production order process with job status boards to manage drug and comp. receipts, incoming inspection, quality assurance approval, material staging and other activities through operations for production readiness.

Performed Lean and Six Sigma projects with purpose of increasing productivity, reducing costs and eliminating waste.

Formed process mapping team to streamline batch record handling and throughput in organization so batch record was approved and ready for production.

Created “Obeya” or “War” room with KPIs, metrics, project plans, activity calendars, problem-solving tools, etc. Trained and modeled how to lead for division leaders and operational managers.

Interim Production Manager (2013-2014)

Managed 35-person organization with two production supervisors and planner/scheduler as direct reports in cGMP contract clinical manufacturing and packaging operation, achieving performance KPIs, such as safety, waste, OEE and OTIF goals.

Improved planning and scheduling of clinical manufacturing and packaging orders from contract order through manufacturing, increasing throughput by 30% and improving on-time delivery by 22% over six months.

Implemented Lean Six Sigma projects throughout organization; implemented operational and process improvements in manufacturing and packaging.

Investigated and wrote deviation investigations and implemented CAPAs in operation to close out backlog of late deviations.

Introduced tier management system in plant, concentrating on manufacturing and packaging.

Merck & Co., Inc., West Point, Pennsylvania 1998 - 2013

One of the largest multinational pharmaceutical companies in the world; with revenues of $47B.

Manager, Sterile Supply Operations (2011-2013)

Managed large sterile supply operation that washed qualified stainless steel parts and assembled and sterilized equipment and glassware for sterile manufacturing for portfolio of vaccine products in 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).

Achieved zero regulatory observations during inspections throughout years 2011, 2012 and 2013.

Significantly reduced deviation investigations in department by over 20% in each of two years by improving SOP adherence and training.

Lowered labor costs by managing OT hours to near zero over 12-month period by increasing people productivity and equipment uptime.

Improved productivity at qualified washers from three to four batch loads per shift, and increased throughput by reducing labor and 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. Improved schedule adherence by 15% despite high equipment downtime and maintenance requirements.

Planner/Scheduler, Solid Dosage Pilot Plant, Clinical Manufacturing (2007-2011)

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). Served as pilot plant gatekeeper, leading daily and weekly production scheduling meetings to discuss and plan upcoming campaigns. Led project management for manufacturing teams.

Increased clinical batch throughput by 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 $5.3M (2008) and $2.2M (2009) by increasing operation's productivity and manufacturing capacity. Furthermore, avoided huge delays in clinical supply to clinics with no delayed studies. Serviced manufacturing partners by scheduling and meeting requested start dates within two-week period while keeping operation's on-time equipment metric 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, improving on-time delivery by 18% and enhancing communication on project management with internal customers.

Redefined SDP pilot plant clinical batch full capacity by 133% (300 to 400) by demonstrating increase from 225 batches to 365 batches in one year. Addressed senior management concerns that 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.

Process Lead, Materials Management, Weigh & Dispense/Chemstock (2005-2007)

Performed process improvement/cost reductions, safety and environmental compliance projects, capital projects, department KPI 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 and non-conformance lead investigator for quality improvement projects.

Provided coverage for manager and assumed additional responsibilities after manager’s position consolidated in July 2007.

Achieved five straight years of near-flawless manufacturing, quality and service as productivity increased and on-time deliveries reached 100%. Attained outstanding department quality and safety records, with few minor human errors and injuries during period.

Recognized by Sr. Director with Division/Staff Area Award (2006) for implementing innovative approach to providing manufacturing supplies to customers and exceeding expectations by using pick and pack concept. Made common supplies available to sites 24/7.

Rolled out Lean concepts, including department planning and assignment tool that utilized concept of visual workplace, which improved department productivity by 27%.

EDUCATION

The Pennsylvania State University, University Park, Pennsylvania

Bachelor of Science in Industrial and Manufacturing Engineering

ADDITIONAL TRAINING & TOOLS

APICS Certified Supply Chain Professional (CSCP, Dec. 2020)

APICS CPIM, Five Classes Completed (Expected Cert. 2022)

Project Management Training (Merck & Fred Pryor)

IISE & APICS Local Chapter Member & Participant in Tours/Events

SAP, JDE, QAD, Minitab, TrackWise, Documentum, Pilgrim

MS Office, Project, Visio, AutoCAD & Other Software Applications

Agile Project Management & Data Analytics & Management Intelligence: Power BI

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