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Project- en interim Management

Project- en interim Management

Work Experience

Summary: 26 years experience as projectmanager and experience in a diversity of operational positions within the pharmaceutical and food industry in Europe, USA and Asia.
Assignments in the fields of Operations, Engineering, Project Management (including BSL-3/Class A/B cleanrooms), Manufacturing, Quality Systems, Validation, Logistics and Change Management.


Projects 2001/08 as Interim Manager / Consultant

May2007/Dec2008 (USA) Biotechnology Pharmaceutical Company.
Quality Manager (preparation of organization for launch of first product).
Organization has no experience with application and implementation of pharmaceutical law (cGMP) in their business processes, which is a necessity for market-approval. As Quality Manager the Quality Systems adapted and successfully defended during the so called “Pre Approval Inspection”. During this period lead 2 departments: QA and QC-Laboratory.
Done projects: implementation (preparation) of Cleaning Validation (Equipment/rooms), Process Validation, Equipment Qualification, Problem Solving Methods, Finalizing refurbishment cleanroom, move of laboratory and the technical document for the process (flow), including manufacturing instructions, analytical- and inprocess tests, material balances etc.
Direct reports: 2 Directors (PhD-level), total 7 FTE.

Jan2007/Aug2007 (Netherlands) Cleanroom complex
Project Manager (finalizing new cleanroom complex)
Preparation of cleanroom-complex for an inspection by the government.
At the start of this project the cleanroom complex (Class A/B/C-BLS-2) couldn’t be approved as result of lack of evidence that equipment, utilities and complex were qualified. By application of better methods for storage of technical documentation and execution of additional tests, the complex could be approved.
A team of 5 people (BSC/MSc level) worked on this project.

Feb2006/Apr2007 (USA) Biotechnology Pharmaceutical Company
Project Manager (3 projects, tech transfer, refurbishment of cleanroom)
Twice a technical transfer organized. Responsible for the manufacturing of a vaccine at a Contract Manufacturing Organization (CMO), meaning transfer of knowledge from contract-giver to the CMO-organization. Transferred information encompassed methods and instructions for manufacturing, analytical- and inprocess testing, quality requirements and material flows. Both attempts were aborted and finally it has been decided to launch the product out of the existing cleanroom complex, which lead to my third project:
Developed a project-plan (3.9 M$) for the refurbishment of the cleanroom, upgrade of the quality systems and the required changes to the organization.

Dec2005/Jul2006 (Netherlands) Pharmaceutical Packager
Project Manager (Workstream Manager)
Change of 2 workstreams and solving the problem of old deviations. There were too many old deviations unsolved which had led to organizational problems and is potentially a serious problem for upcoming inspections. During this project 70 out of 80 old deviations solved, which was acceptable. Introduced changes to the business process to prevent repeat.
A team of 8 people (BSc/MSc/PhD-level) worked on this project

Jun2005/Jul2005 (India) Vaccine Manufacturer
Project Manager (Feasibility Study)
Study on feasibility of increased automation of 12 packaging-lines in 5 plants in Pune. Created report expressing that complete automation will become too complex, partly automation could reduce costs.
Stand alone project.

Jun2005/Dec2005 (Netherlands) Pharmaceutical Company
Plantmanager Central Sterilisation Department
Disapproved Plant (for pharmaceutical use). Procedures, workflows and building didn’t meet the requirements. During a relatively short period (2 to 4 months), procedures improved, major reconstruction done, motivated personnel, workflows improved as well as delivery reliability.
Inspection was satisfied with the results, after the inspection continued with improvements.
Direct reports: 15 (lower vocational level) including supervisors (BSc-level)

Jul2004/Jun2005 (India) Pharmaceutical Company
2 assignments: Project Director (Building a Pharmaceutical Plant) and Quality Manager
The erection of the plant (for Water for Injection –WFI-) was enormous delayed due to lack of know-how of managing a pharmaceutical project and implementing Pharmaceutical Quality Systems. When the assignment started (16 months after start of construction) the plant should have been ready.
New (realistic) planning made, increased amount of construction-people, as Quality Manager: implemented all procedures (approx. 400) and phased start-up of plant (including aseptic Class A/B suites)
Finished On Time In Full (addressing new made planning), followed by helping this company to obtain a license of WHO (World Health Organization) necessary for delivering product outside India.
Plant: 80 workers
Construction: 250 workers

Apr2004/Jan2005 (USA) Pharmaceutical Biotechnology Company
Project Director (Building a Pharmaceutical Plant))
Responsible for the building of a Pharmaceutical Plant, including Quality Systems and creating the organization, for the manufacturing of 50 million doses of vaccine.
Expected total costs between 30 and 50 million dollar. Completed basics of Design, Process flows, Material balances as well as organizational and quality requirements. Due to not obtaining product-licenses, this project was canceled.

Jan2004/Okt2004 (Netherlands) Pharmaceutical Biotechnology Company
Manager Validation Department
Preparation for FDA-inspection. Managed a group responsible for the validation of all operations. Major challenge: technical documentation of Equipment (1200 pieces), which was not done properly by this company. Amount of teammembers: approx. 7 (BSc/MSc/PhD-level)

Jan2002/Jun2004 (Netherlands) Pharmaceutical Gene-therapy Company
Manager Operations
Start-up of an organization for the production of small amounts of biotechnological for clients and their own gene-therapy products. Organized a complete renovation of one cleanroom (BSL-3; Class A/B) and a new cleanroom (BSL-3; Class A/B). Per project the budget was 200.000 Euro. At start of assignment the last manufacturing-employee left the company, and as a result have built-up a complete new organization. Due to not functioning of the Quality Systems and lack of validation the cleanroom complex couldn’t be approved. This has been solved during this period as well.
One other major project was rebuilding one cleanroom complex due to water damage. This has been solved within 3 months including complete re-validation.
Other activities: acquisition to increase occupancy of cleanroom
At end of project: 10 employees (BSc/MSc/PhD-level)

May2001/Aug2002 (Netherlands) Food Industry
Project Manager (Validation)
Assignment: writing of Masterplans and execution of Process-validation and Cleaning-validation of 2 sites of an international foodindustry company

May2001/present (Europe/India/USA):
Continuously: giving training and presentations for pharmaceutical production and Quality Systems as well as more general operational training (both internal and external)

--------- as employee -------

1999/2001 Quest International [ICI], Maarssen (NL) – food industry
Site-manager, Responsible for the Manufacturing Site Maarssen, including maintaining high standard on safety. This site contained 2 plants, one for proteins and one for salty ingredients. Products were all for Business to Business.
Main additional activities: Environmental license renewed, implementation ISO9002 (which was 7 years delayed), chairman HACCP-committee, introduction electronic documentation system (Lotus Notes-based).
Remarkable improvements: increased delivery reliability, sickness percentage decreased, productivity per employee increased.
Direct reports: 5 (from college to MSc-level), indirect reports: 70

1999 PharmaPack, Zoetermeer (NL)
Head production and techniques, of a pharmaceutical-packaging-firm.
Direct reports: 3 (BSc-level), indirect reports: 52

1993/98 Wyeth (Fort Dodge Animal Health) (formerly Solvay Pharmaceuticals), Weesp (NL)
Production Manager (jan93/may96) Responsible for the day to day management of the biological production of viral vaccines under clean room conditions.
Shortly after I arrived this plant was disapproved by an inspection.
Major assignments: quality systems improved, production-mentality implemented, consistent process conditions implemented, logistic problems solved (including waste-streams), training of operators, all procedures rewritten.
Direct reports: 3 (MSc-level), indirect reports: 12

Continued,
Director Technical Department. (jun96/dec98) The merge of Solvay AHD with Fort Dodge (a fully subsidiary of AHP = now Wyeth) necessitates a new independent technical group.
Major projects (e.g.):
• start-up new department,
• Implementing Qualification Philosophies (IQ. OQ, PQ)
• Implementing a bioreactor and a new controller for a nitrogen freezing machine.
• procurement freeze-dryer 28 m2 [300 ft2], pre-engineering, negotiations, validation-masterplan, project plan and budgeting-system for costs control. Project included refurbishment of aseptic suite. Budget approximately 4 million dollar. This freeze-dryer has gone to another site of Fort Dodge.
• pre-engineering for a high-speed aseptic filling line (30.000 vials per hour).

1991/93 AGA Gas B.V., Amsterdam & EMBA Techniek , Dordrecht (NL)
Sales-engineer, applications for gasses respectively for pumps

1983/91 DSM Biologics (formerly Gist-brocades N.V.), Delft (NL)
Technician, Production of cephalosporin’s (bulk) by physical en chemical reactions.
Associate Project-Manager, statistical and technical investigations on bulk-manufacturing and implementation of data-acquisition systems...

1978/83 RVS Levensverzekeringen N.V., Rotterdam (NL)
Arithmetical-employee, arithmetical operations for insurances and pensions.



Education

1978 Higher secondary education
1986/89 Pre-university (VWO).
1989 Colloquium, University of Technology Delft
1989/90 Propaedeutic, University of Technology Delft, Chemistry, Mathematics, Biotechnology and Information Technology. Practical works (60% of volume), Physics, Chemistry and IT.
1990/96 Institute of Technology (Process)

In summary: trained on: Safety, Good Manufacturing Practices, Microbiology, Manufacturing Excellence, Commercial and Behavioral skills; A specification is added to this Resume


Skills

International experience, endresult oriented.
Maintaining oversight but with an eye for the details.
Zelfmade, started from the shopfloor
Seasoned manager of people and behavior, always from the positive side.


Languages

Dutch: native language.
English: good (worked and lived in the USA)

Other

Experienced with (new)buildingprojects from minor to major and with managing departments or companies as well.

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