Tob Management – Etten-Leur (The Netherlands)
Assignments are listed from most recent to earlier
Senior Project Manager Global Cryopreservation Liège/Houston (Belgium/USA)
Lead for the physical completion & cGMP hand-over of cryopreservation facilities, initially one in Liège (Belgium) and another in Houston (USA) to the Operations group, offering an integrated set of cGMP services in line with the regulatory, quality, and cGMP requirements of the Cell & Gene Therapy Industry
Senior Project Manager – Gosselies (Belgium)
For Catalent Cell & Gene Therapy, successfully finalising, delivering, and handing over a plasmid/pDNA facility to Manufacturing, ready to be used to produce plasmid, with a positive opinion from the AFMPS.
Head of Engineering – Leverkusen (Germany)
Leading the Engineering, Maintenance, Calibration, Validation, Facilities, and EH&S function in a recently acquired CDMO site, integrating new team members into the existing organization and maturing the Technical function at the same time, whilst delivering on the promises to the customer.
Radiopharmaceutical Development – Berlin (Germany)
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. The 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.
Medical Device Development – Utrecht (the Netherlands)
Supporting a privately owned medical device company, focused on the provision of novel bioresorbable medical solutions that are safe, effective and cost beneficial for the intended use, specifically for minimally invasive treatments in the field of soft tissue augmentation, with Validation expertise in preparation of ISO-13485:2016 certification
CDMO – Biologics – Groningen (the Netherlands)
As a member of the Engineering Leadership Team, joining to backfill the Validation Manager’s position, who made promotion internally. Around the same time, two validation Engineers left the organisation and support was needed to move through a challenging period where the team was stretched for resources, with high workload and external challenges, such as the Covid-19 restrictions. The vacancies were sourced and offers made to enforce the team. With the Validation Manager hired, I continued with the hand-over to support smooth transition of departmental responsibilities.
Cell & Gene Manufacturing Site – Hoofddorp (the Netherlands)
In three different roles, over the time span of 14 months, I have supported the organisation, adhering to GEP Guidelines, developing, delivering, and providing training for GMP-compliant processes, procedures, and instructions. Modifying and implementing 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 Sister sites across the Globe.
As Manager Engineering responsible for building up and leading the engineering team for the newly built manufacturing site in Hoofddorp (NL). With my team of engineers and specialists responsible for engineering tasks, CapEx project execution support, third line Manufacturing support and maintaining and developing engineering knowledge and standards for the 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. Project involvement as a senior people manager with a focus on operational resource Management. Ensuring projects are executed safely, efficiently, and following all applicable codes and Corporate Standards. Providing expert advice to managers regarding technical maintenance, operations or management issues. Building and managing an effective Engineering team and ensure that all personnel are fully aligned to their customer needs and requirements, providing an excellent level of service. 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 Cell & Gene Manufacturing Facility in Hoofddorp.
Radiopharmaceutical Laboratory – Berlin (Germany)
Project Manager for Masterplan development; with the short-term goal for the extension of the existing radiopharmaceutical laboratory and the long-term goal for a new radiopharmaceutical laboratory for R & D, for clinical development, and scale-up Development.
Built the environment to allow focus and decision-making in the project for the satellite team in Berlin and corporate management at the Paris headquarter, both for the short-term and long-term solution, with specifications for layout, organisation, equipment, and implementation. With an Engineering Design company, I prepared the Business proposal (30% accurate) and had it presented to the Executive Board by the Site Manager.
Diagnostics Laboratory – Rijswijk (the Netherlands)
Director Project Management a.i. for the Project Management Office within a recently established new organisational structure. I introduced and matured Process Thinking and Systems Design for the team of the Project Management Office and consequently for the entire Diagnostics Services organisation. Management & reporting structure mapped and rationalised. Training courses designed, developed, and delivered. Rolled out the new structure, supported with forms, reports, KPI’s, and IT Tools, implemented through coaching and mentoring. Rolled out Atlassian’s Jira Project Management software.
Private Equity Company – London (United Kingdom)
As Pharmaceutical Compliance Expert, part of the team assisting a Private Equity and Venture Capital Company with Compliance Assessments for the carve-out of the OTC Business (predominately Eastern Europe based) of a French Multinational Pharmaceutical company. The Assessment included Site visits, in-depth QMS review, Regulatory Authority Inspections Review, and deviations & CAPA review.
Clinical CMO transition to commercial CMO – Groningen (the Netherlands)
Whilst in the transition from a mostly clinical CMO to a primarily commercial CMO, driving Change for the Technical Organisation directly and for the Organisation at large indirectly, heading for full Commercial BSL3 CMO Facility. Supplier Qualification for Equipment, MRO parts, and services such as Clean gases, Pest Control, Cleaning, and Maintenance. Lead for Engineering to eliminate 120+ days and reduce the 90+ days and 30+ days open observations, deviations, and capa’s.
With the 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 organisation for the deliverability of products and services to support the growth of the company.
Site Lead for maturing the existing QMS to be inspection ready for FDA, and EMA Inspection, with initial assessment, GAP Analysis and closure program.
GMP-Compliant Facility retirement – larger Dortmund area (Germany)
As GMP-Expert and PMO-coordinator leading the GMP-Compliant retirement of a Manufacturing Facility for a renowned Multinational Company. Winding down production to full-stop, de-qualification of all the GMP systems, decommissioning all equipment and installations, and demolish everything. Subsequently refurbishing the Site to a regional Logistics hub, overhauling and upgrading the underground infrastructure and external road and fencing.
Medical Nutrition Site conversion – Zoetermeer (the Netherlands)
At the Baby nutrition Facility, converting into a Medical Nutrition Manufacturing Site leading the Engineering department and Project Management Office, a team of 17; comprising Sr. Project Managers, Project Engineers, Process Engineers, Industrial Automation Engineers, and draftsmen. Providing Departmental Leadership, implementing Project management rigour for Capital Investment proposing, Tendering and Execution; covering Civil, Utilities, Liquid Processing, Filling & Packaging, and Palletizing.
I was the department lead with projects for a new building; liquid processing equipment, and filling & packaging lines. Two aseptic pouch lines with up-stream processing equipment building expansion for new blow-moulding equipment; Several smaller projects for new bottle format; for new spout format; multi-line, multi-format palletizer & wrapper. Ahead on the preparation for an FDA audit, I also was the lead for the QMS-maturing project; with an initial QMS assessment, the GAP Analysis, team formation in the different department and as the lead for the GAP closure program.
Hygiene Film Producer – Rétsàg (Hungary)
New hygiene Film (top sheet feminine napkins) factory in a rural area, 45 miles ( 60km) north of Budapest, in the village of Rétsàg [Nógrád county]. Together with the Ministry of Economic Affairs and a Dutch Logistics Consultancy company, I developed a long-list of 17, reduced to a short-list of 2, with a final selection for Rétsàg. Negotiated the purchase of the agricultural plot submitted the environmental and building permit, contracted two separate high-voltage powerlines to the site. Selection & negotiations for the main contractor, the architect, and the local project management company. I was lead of the project team for the design & construction of the facility, the hiring of the local employees, and the training and development program to successful inauguration by the ambassador of the USA in Hungary and star-up of the facility within 12 months after project kick-off.