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Dr. Detlef Weber - Mein Werdegang

Dr. Detlef Weber

Expertise as: Interim Management / COO / Head of Site / Head of Production / Quality Engineering

 

Key skills and relevant experience:

  • Leadership experience as Site Director, COO, Head of Production in Life Science, Pharma, Food in Production, Quality Management, in HACCP / IFS / BRC / gxp inspections / audits as spokesperson, and as lead in investigations/CAPA

  • Phd in Physical Chemistry and Specialist in Pharma / Biopharma (solid oral drugs, monoclonal antibodies, mammalian cell culture products), in gxp-environment

  • Quality Engineering Specialist (CQV)  in in pharma, biopharma, validation processes (IQ, OQ, PQ), FAT /SAT, PPQ, data integrity, inspections, Qualification protocols (IQ,OQ,PQ), Qualification Cleaning Validation (IQ,OQ,PQ)

  • Equipment, utilities and facility design, build and qualification in several Greenfield and brownfield projects

  • Scheduling for SIP, Microbial Hold Study, Cleaning Validation during Dev.Run and ENG.Run

  • Expertise in Lean Management

  • Experience in cross-functional teams, communication by Shopfloor-Management / Dashboards / AOS to ensure consistent commissioning / validation processes in quality management and in operations

  • Strong practical expertise in CQV and Tech-transfer in Life Science / Pharma / Biopharma

  • Strong in Shopfloor Management (hands on),

  • Quality Engineering, deviations, change controls, work orders and any technical documentation, Execution System (global and local computerized systems), risk analysis, root cause analysis in GMP environment

  • Strong hands-on mentality, proactive and goal-oriented

 

Qualifications/Education: Dr. rer. nat., Dipl-Ing Verfahrenstechnik

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BRIEF DESCRIPTION

 

Sectors and main topics

 

Bio-Pharma:

Quality Engineering Specialist (CQV), Scheduler (Production and Facility Schedule)

 

Pharmaceutical industry:

Site extension project, role: Process Interface Manager (PIM),

Head of Production (bulk, solid oral drugs), Project Manager CAPEX,

 

Food industry:

restructuring / expansion, function as Operations Manager, COO, Process Manager

Chemical industry: Plant manager of a plant in the SEVESO category

 

Experience and knowledge

 

Management of Plant / Operations in the process industry in various phases of change and transformation, project management of "brownfield" and "greenfield" projects. all relevant GMP environment

Optimization of operating results on the basis of key figures (eg OEE), with a focus on the “from bottom to top” approach, optimization of processes and technical procedures (KAIZEN), also in process automation, introduction / optimization of maintenance systems (spare parts,data acquisition, data evaluation and implementation of measures), organization of maintenance downtimes, digitalize Performance Boards/workstream (AOS standard).

CQV Specialist in in pharma, biopharma, validation processes (IQ, OQ, PQ), FAT /SAT, PPQ, data integrity, inspections

Deviation Management risk analyses, root cause analysis in GMP environment

Many years of experience in the application of the "tools" root cause analysis, Ishikawa diagram, weak point analysis, risk analysis, extensive knowledge of „5S“ and lean management, in daily routine: Gemba-Walk, visual management, communication via OKR method, manage DMAICs

 

Personality

Goal-oriented, convincing, conscientious, hands-on mentality, advancing the work with team spirit in the sense of “challenging and promoting”, taking into account the necessary intercultural cooperation in the teams. Very experienced in managing the various interfaces in the company. Active in sports, strong resilience.

 

Languages

  • German native language

  • English Business fluent in spoken and written

  • French Business fluent in spoken and written

 

Continuing education / courses

  • Associate Director in Pharma Production (Solid Oral Drugs)

  • GMP training with various certificates

  • "CRO training" course for functions within the scope of S6 reports

  • Qualification in occupational safety (SCC manager for construction sites of all kinds)

  • Personnel management through target agreements (PENTA, OKR)

  • Operational Excellence (OEE by Mainpoint, USA)

 

IT / EDP skills

  • All common job-specific application programs as well as working with all GMP-relevant tools Trackwise, Syncade,

  • Kneat, CIMMS, COMOS, Oracle, DeltaV, SAP

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SKILLS AND COMPETENCES

 

Summary of Core-Competence

 

Application of this candidate for the following 1-5 reasons:

  • PhD in Physical Chemistry and 5 years’ experience as Specialist for Technical platforms in Pharma / Biopharma (solid oral drugs, monoclonal antibodies, mammalian cell culture products)

  • 20 years of Leadership experience in Project Mgmt, Production, Quality Management, in HACCP/IFS/BRC/GxP inspections/audits as spokesperson, and as lead in investigations/CAPA

  • high success in leading cross-functional teams (several acknowledgements and awards), communication by Shopfloor-Management / Dashboards / AOS to ensure consistent manufacturing processes and quality

  • strong practical expertise in scale-up and Tech-transfer in Life Science / Pharma / Biopharma

  • strong hands-on mentality, proactive and goal-oriented

  • Lead in Lean Management, Investigations (Yellow Belt), Occupational Safety

 

Practicals:

  • Average commuting time: approx. 30 min

  • Hours available per week: (min) 42 hours

  • Days available on site (min-max):  5 days per week

  • Availability to start or notice period: 15AUG22

  • Currently employed or engaged (Yes/No) : Yes

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Mitglied bei LEVERAGE EXPERTS

Leverage Experts AG (LE) wurde 2012 in Zürich als eigenständige Gruppe interdisziplinärer Experten gegründet.

Das erfahrene Team unterstützt Unternehmen bei komplexen und kritischen Herausforderungen mit einer strategischen Denkweise und einer Leidenschaft für die Implementierung.

 

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Dr. Detlef Weber
manager
change & transformation (DE)

Dr. Weber ist einer der erfahrensten Experten in Europa für Total Productivity Management und Operational Excellence vorwiegend in der Lebensmittel-, Pharma- und Biotechnologiebranche. Er schafft durch klare Analyse der Abläufe und Identifikation von Auffälligkeiten mittels Shopfloor-Management und Performance Boards (AOS-Standard) einen schnellen und erfolgssicheren Turnaround. Er steuert die Prozesse von komplexen Produkteinführungen und konzipiert kundenorientiertes Qualitätsmanagement auf Basis seiner großen Expertisen in validen Root Cause Analysen.

Kompetenzbereiche

  • Total Productive Management

  • Verfahrenstechnik

  • Lean- und Qualitätsmanagement

  • Prozess-Design

  • Operative Exzellenz (OEE)

  • Industrie 4.0 (Digitale Prozesse)

  • OKR-Projektmanagement GEMBA

Hier ein kleiner Einblick in meine Arbeit:


 
Video zum Thema Interim Management

Was Sie als Kunde oder Kollege von den Besten der Branche lernen können
Hier geht´s zum Videobeitrag beim Fernsehsender ARTE
(Meine Reportage beginnt ab Minute 10:10)


Und hier noch ein Video zu meinen Arbeiten in Frankreich:
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