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Is It Time To Stop Using Mean Kinetic Temperature (MKT) In Pharma Storage Transport - BioProcess Online

HTS-"Amsterdam"

Cranfield School of Management

Amsterdam University of Applied Sciences

Ds Pierson Schoolgemeenschap

Sr. Manager (interim), Operational Consultant, Mentor & Coach in Biotech, (Radio) Pharmaceutical, Cell & Gene, Medical Device, Food for Medical Purposes Industry

Etten-Leur, North Brabant, Netherlands

Change is the only constant factor, can't change that! Plenty of new ideas, but can we get away from old insights?Consultancy, Interim & Project Assignments in Change Management, in Leadership and Management Setting; particularly in General, Engineering, Maintenance, Supply Chain and Facility Management in highly regulated environments; Biotech, Pharmaceutical, Radiopharmaceutical, Medical Devices, and Food for Special Medical Purposes.Assisting Private Equity and Venture Capital Clients with Pharmaceutical Compliance Assessments for Business Process Restructuring (BPR)  and Mergers & Acquisitions (M&A).Providing Clients with GxP-Compliant Facility and Location Retirement Planning & Execution Support Worldwide.Providing Clients with Qualifying Supplier Audits according to GLP, OECD, GDP, GMP, and WHO, and follow up requalification audits Worldwide. Providing Consultancy Services on GxP Compliance according to FDA, EMA, and WHO, especially in Compliance, Validation, Qualification and Supply Chain, Warehousing, and Distribution for Warning Letter/Consent Decree remediation Worldwide. Maintenance, Validation & Calibration Systems Design Expertise for Highly Regulated Businesses such as Pharmaceutical, Radiopharmaceutical & Medical Device Industries, Biotech, and Food for Special Medical Purposes.Industrial Masterplanning Expertise for Greenfield (new facilities in a new location) and Brownfield (refurbish existing; new facility at an existing location) Sites in Highly Regulated Environment; (Radio-)Pharmaceutical, Medical Devices Industry, Biotech, and Food for Special Medical Purposes Worldwide.Leachable & Extractable Expertise in Pharmaceutical setting for Immediate Packaging Systems

Tob Management

Managing Partner / Owner

At Quality Executive Partners (QxP), our mission is to bring bold revolution to quality consulting. We are fuelled by the passion for doing what is right and being the much needed disruptive innovation! There may be nothing revolutionary about passion, but we turn that passion into real value, built on integrity and long-term client partnerships. And, in our industry, that is revolutionary.The QxP team is comprised of executives with extensive track records delivering successful outcomes in situations of intense regulatory scrutiny. Our executives have substantial experience interacting and negotiating with FDA and other global regulatory agencies. We take a pragmatic, strategic view of internal processes, quality system development, and implementation of key matters. Our approach is to “do and teach.” We assist our clients in developing Quality and Compliance organizations and leaders, all while getting real work done.My expertise is in Engineering Services, Equipment Qualification, Maintenance, Supply Chain, Warehousing & Distribution. I perform audits, identify gaps, and develop remediation plans. I work within the organization to assist with deviation investigations and CAPA implementation; the focus is on developing scientific, risk based solutions. I have in-depth knowledge of US and EU regulations.

Quality Executive Partners, Inc. (QxP)

Partner / GMP Compliance Consultant / SME

As CMC & Supply Manager responsible for Validation oversight and Support to drive the technical development of 177-Lutetium and 111-Indium based radiopharmaceuticals in clinical development for Diagnostic and Therapeutic Cancer Treatment.OctreoPharm Sciences GmbH is part of Ipsen S.A. developing Systemic Radiation Therapies (SRT). Systemic therapy involves treatment that travels through your entire body rather than being aimed at one area. Systemic radiation therapy uses radioactive drugs to treat certain types of cancer, including thyroid, bone, and prostate cancer. These are liquid drugs made up of a radioactive substance. Although these drugs travel through your whole body, they can find and collect in places where the cancer cells are located. This helps them deliver radiation doses exactly to the tumour or area where the cancer cells are found. Some belong to PRRT, peptide receptor radionuclide therapy. This treatment combines radioactive material with a peptide to make a radiopeptide. When given, the radiopeptide finds and attaches to certain types of cancer cells, then delivers a high dose of radiation directly to the cells.

OctreoPharm Sciences GmbH

CMC & Supply Manager (contract)

Supporting the department manager and the team members, after a challenging period in which the Validation team was stretched for resources and competencies, to return to steady-state.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.The Groningen site specializes in cGMP for (pre)clinical and commercial manufacturing, including mammalian cell culture manufacturing, scale-up and cGMP manufacturing of recombinant proteins and monoclonal antibodies. Additionally, late-stage process development services include:In-house analytical capabilities, QC and QAFed-batch and perfusion processesExperience with all mammalian cell linesSingle-Use and flexible stainless steel technologiesGroningen has a strong regulatory and inspection history, beginning in 1994 and is part of Patheon's global network of biologics sites, which also includes Princeton, New Jersey, St. Louis Missouri, USA, and Brisbane, Australia. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

Thermo Fisher Scientific

Validation Specialist & SME (contract)

As a member of the Engineering Leadership Team, responsible for the maintenance of the validated state, lead of the Validation Team for Commissioning, Qualification [CQV & CSV], and Periodic Review of Facilities, Equipment, Instruments, and Systems of the Groningen Site, for routine and CapEx projects. Hired to move through a challenging period with vacancies for the department lead, Staff Validation Engineer and Validation Engineer II & III, closing the resource & competency GAP was top priority.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.The Groningen site specializes in cGMP for (pre)clinical and commercial manufacturing, including mammalian cell culture manufacturing, scale-up and cGMP manufacturing of recombinant proteins and monoclonal antibodies. Additionally, late-stage process development services include:In-house analytical capabilities, QC and QAFed-batch and perfusion processesExperience with all mammalian cell linesSingle-Use and flexible stainless steel technologiesGroningen has a strong regulatory and inspection history, beginning in 1994 and is part of Patheon's global network of biologics sites, which also includes Princeton, New Jersey, St. Louis Missouri, USA, and Brisbane, Australia. Our global team of more than 75,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

Validation Manager (contract)

As Facilities, Maintenance & Engineering Specialist, adhering to GEP Guidelines, developing, delivering, and training GMP-compliant processes, procedures, and instructions. Among others, Facilities Cleaning, Preventative, Predictive, and Corrective Maintenance, also Asset Life Cycle Management. Review, modify and implement various Engineering policies and procedures, aligned with other Facilities programs and regulations; Minor Miscellaneous Projects and CapEx Project processes and procedures, in close collaboration with  Corporate and Similar Kite Pharma sites across the Globe.About Kite Pharma, A GILEAD CompanyKite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company focuses on chimeric antigen receptor (CAR), and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognise and kill tumours.Kite Pharma Europe is currently building a state-of-the-art manufacturing site in the Netherlands (Amsterdam-Hoofddorp) as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.

Kite Pharma

Facilities, Maintenance & Engineering Specialist

As Manager Engineering responsible for building up and leading the engineering team for the newly built manufacturing site in Hoofddorp (NL). In this role, my team of engineers and specialists will be responsible for engineering tasks, CapEx project execution support, third line support and maintaining and developing engineering knowledge and standards for Kite’s commercial manufacturing site producing autologous T cell therapy products.•	Responsible for complex Engineering programs with global reach.•	Leading the day-to-day activities of an engineering department.•	Review, modify and implement various Engineering policies and procedures, aligning with other Facilities programs and regulations.•	Project involvement as a senior people manager with a focus on operational resource management.•	Ensures projects are executed safely, efficiently, and following all applicable codes and Kite/Gilead Standards.•	Provide expert advice to managers regarding technical maintenance, operations or management issues.•	Manages the engineering services including interface with external contractors and vendors.•	Builds and manages an effective Engineering team and ensure that all personnel are fully aligned to their customer needs and requirements, providing an excellent level of service.About Kite Pharma, A GILEAD CompanyKite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company focuses on chimeric antigen receptor (CAR), and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognise and kill tumours.Kite Pharma Europe is currently building a state-of-the-art manufacturing site in the Netherlands (Amsterdam-Hoofddorp) as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs.

Engineering Manager a.i.

In a very fast (double digit’s) growing organisation collaborating with Supply Chain, Materials Management, Manufacturing, IT, HR, and Finance, to build the system, processes, and procedures for Facilities, Maintenance & Engineering in support of the launch of the Yescarta Manufacturing Facility in Hoofddorp later in 2019.With guidance from the Facilities & Engineering Mission: Deliver and maintain safe, reliable facilities that are compliant, cost-effective, and sustainable through a collaborative environment that is focussing on teamwork and best-in-class process. Kite Pharma, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st-century medicine: Curing Cancer. This mission is at the heart of everything we do, from early research to product development. Today, Kite is a leader in engineered T-cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, we want to bring life-saving therapies to patients.

Consultant Facilities (Contract)

Contract Project Manager for Commercial Contract Manufacturing Organisations for the End-to-End Supply of Therapeutic and Diagnostic Radiopharmaceuticals; for Packaging CMO for Primary & Secondary Packaging for Clinical Supply.

Ipsen

Project Manager (Contract)

Manager Project Management a.i. Assignment for Masterplan development; with the short-term goal for the extension of the existing radiopharmaceutical laboratory at the campus and the long-term goal for a new radiopharmaceutical laboratory in the Greater Berlin Area to support R & D, clinical development, and scale-up Development work. Worked with Paris Headquarters and Berlin local Management to develop the long-term view, design the facility, identify potential sites, and prepare Business Opportunity Capital Approval Request & schedule.

Manager Project Management a.i.  - Masterplan development

Lead for the Site Expansion Project at Patheon Biologics Groningen, covering a new Warehouse, Relocating & Refurbishing the existing Warehouse, adding Manufacturing Capacity & Capability, and Office Space.

Patheon

Project Manager CapEx a.i.

Driving Change at Patheon Biologics B.V. Groningen for the Technical Organisation directly and for the Organisation at large indirectly, heading for full Commercial CMO. The FME Team covers Facilities Management, Maintenance, Calibration, Validation, Engineering and Technical Projects.With focus on the challenges of acquiring and integrating human capital during rapid growth while managing risk in relation to variable costs, maintaining quality, and preparing the organization for deliverability of products and services to support the growth of the company.

Facilities, Maintenance, Engineering Director a.i.

Providing Advisory Services in Leadership and Management for a diverse array of portfolio companies.Advisory and Support Services for client companies in preparation or execution of the client business.

Sidestarter Ventures

Independent Advisor

The Rapid Growth Board focuses on managing industry agnostic elements of rapidly scaling enterprises. With a particular focus on the challenges of acquiring and integrating human capital during rapid growth while managing risk in relation to variable costs, maintaining quality, and preparing the organization for deliverability of products and services to support the growth of the company. Board members include top executives with experience in scaling large organizations and range in areas of expertise from supply chain management, process development and execution, capital structuring, human capital acquisition and integration, and information technology.

ExecReps

Independent Director, Rapid Growth Board - ExecReps Inc.

Mentoring and Coaching student(s) with their (minor or major) practical term assigment in Prince2 Project Management

Stichting Projectkompassie

Mentor/Coach

Supporting Client on Supply Chain & Logistics and Business IT changes.Coaching & Mentoring on Lean Six Sigma Green Belt & Black Belt curriculum.

Progress-PME

Sr. Pharmaceutical Consultant, SME, Supply Chain & Business IT

Responsible for Engineering Management at the Supply Point Zoetermeer; leading a 15+ FTE department, driving several € 10+ MM projects involving Compliance, Industrial Automation, Site Utilities, Building Renovation and New, Production Equipment and Packaging Lines.

Nutricia Advanced Medical Nutrition, Danone

As Director Program Management Europe responsible  for Program, Project, and Portfolio Management Office. Leading Cost Reduction, Revenue Growth, Lean Six Sigma and Continuous Improvement projects in the UK and N-Europe, Germany and E-Europe, France, Italy, and Spain. In this business I strongly favor Waste Elimination and Lean Approaches, but will deploy any good strategy to achieve the desired targets. In 2008 over delivered 330% on OpEx target. In 2009 completed our first Green Belts class, certified 5 GB, and delivered good revenue and excellent EBITA results. In 2010 certified 2 Green Belts, provided PMO services for a pan European IT implementation, and project managed two new office locations, one in Eastern Europe, another in Eurasia, delivered on target revenue.Negotiated & implemented global sourcing initiative on Translation Services in 5 languages

Wolters Kluwer Pharma Solutions

Director, Program Management Europe

I did Facilities, Warehouse, Supply Chain, Maintenance, Engineering, Projects, Office Management, ICT, EHS/ARBO, and Asset Management, and a team of 13 reporting at this young Biotech Drug Delivery & Contract Manufacturing company. I coached key positions & supported the organization to grow in a mature company.  In the Warehouse faced with tight financial budget, limited storage space, and a large number of SKU’s requiring close monitoring to provide high service and quality levels – the mid-year OTIF was a more then 20% improvement over the previous year. Managing batches with developmental product, single samples, in quarantine and after release, delivering to Customers Worldwide. Requiring tight control to assure correct packaging, storage, shipping & handling, and documenting it all, eliminating re-work. I also managed consolidation of 3 separate sites into a single location; more then triple the footage, requiring rethinking all Facilities Management issues.

OctoPlus

Manager Facilities

As Manager Operational Excellence I was implementing Operational Excellence within the International Consumer Products Group, effectively for more then 20 sites in 10 countries across Europe. In my position I was the driving force for the implementation of programs such as Rapid Transformation(sm), Lean Manufacturing, Six Sigma, 5S, Total Productive Maintenance, SMED, SPC, DoE, Kaizen, CMMS, WCM, Visual Management, Safety, Environmental compliance, together with support tools such as effective meeting structure, Planning & Scheduling,  and infrastructure Support (warehouse systems & spare parts management).

Georgia Pacific

Manager Operational Excellence

As Site Manager I had responsibility over Facilities, Maintenance, Engineering, Project Management, Metrology, Validation, Office Management, ICT, EHS, Capital Investments, Contract Management, and Asset Management. I implemented a management team structure improving communication and increasing awareness between functions. In my position I had 7 people reporting to me and an organization of more then 120 employees. I have expanded the organization from a single site to an organization operating out of three separate facilities (M&S, F&A, HR as one, QC, and Operations each separately) in and around Amsterdam, managing site selection, build out and occupation, whilst maintaining the supply chain performance at very high level

Biogen Idec

Site Manager

During a relatively short time, in my role as Project Manager, trained as Six Sigma Black Belt, I was responsible for implementing change management and operational improvement assignments at customers. I implemented an APS tool for the packaging department of a pharmaceutical plant in Belgium, improving supply chain reliability and reducing warehouse inventory. I installed a supply chain management system improving delivery, quality and cost performance with a Formula 1 racing team in the UK, and I rationalized the maintenance department of a fluor-chemicals site in the Netherlands, improving maintenance service levels and reducing overall maintenance cost.

Celerant Consulting

Project Manager

- As Engineering Manager Europe, out of Terre Haute (IN), USA, for this manufacturer of thin plastic films, responsible for large projects within Europe, and for a cost reduction initiative with the European Utility Suppliers.As Manager Eastern Europe, out of Budapest, Hungary with P&L responsibility, I led the green-field development of the manufacturing location successfully in a timeframe of less then one year.As Technical Manager, out of Kerkrade, the Netherlands I managed all facilities & maintenance for the site.I implemented a PM and PdM program and changed behaviour in the maintenance department, from re-active to failures into pro-actively avoiding downtime.

Tredegar Film Products

Manager

First as Films Technologist at Van Leer R&D in the Netherlands responsible for the technicians in the department, Industrial Packaging projects, SCADA projects for packaging equipment, DoE analyses for research projects, computer projects in the department, and site-wide in-house computer training courses; participated in two company-linked foundations, both with employee benefits aims; co-founder of a personnel association at the Research center. Later As Production Manager Valcross at Van Leer Packaging (Belgium) responsible for commissioning, installation and production of a completely new manufacturing process for strength film, fully compliant with ISO 9002, comprising a three layer co-extrusion line, spiral cutter and cold-seal laminator; responsible for manufacturing, maintenance, and Technical Sales Support.

Tobias Kuners of Koenders

Tobias Kuners of Koenders