Senior Interim-Manager (TechOps Pharma, BioTech, LifeSience), Deviation & CAPA- und LeanSixSigma-Beratung

11/2021 – 4/2022

Leitung der CDMO-Herstellung (feste und flüssige Formen; aseptische Abfüllung)

Lean Prozesse, Produktionsleitung, Good Manufacturing Practices

1/2017 – 10/2021

Head of Operational Excellence
- Introduction of value stream thinking (e2e) as basis of systematical process improvement (Kaizens)
- Support of the establishment of a side-wide re-organization from departments (“silos”) into cross-functional teams to enable e2e accountability
LeanSixSigma BlackBelt in Bio Pharma Manufacturing
- Leading of the Manufacturing Standardization Team (matrix)
- Continuous Improvement Projects (e. g. Lead Time Reduction of the eBRR process - paperless)
- Lean lab: rhythm wheel introduction in QC lab to improve operations of sampling (“Testkalender”)
Implementation Lead for Lean Production System (LPS)
- Implementation of LPS on site in operations and quality

Lean Prozesse, Lean Startup, Good Manufacturing Practices

9/2015 – 12/2016

Head of the Project management / OpEx team Bacterial & Sterile Operations 12 FTE
- Development of a milestone tracking system
- Introduction of a resource planning tool
LeanSixSigma BlackBelt Technical Operations

Lean Prozesse, Lean Startup, Good Manufacturing Practices

10/2006 – 8/2015

LeanSixSigma BlackBelt Bacterial & Sterile Operations
Managing of cross functional / international teams in Marburg & Rosia/Italy
- Successful completion of the project “Lean Supply”: lead time reduction of a business-critical process from > 100 d to 20 d. significant optimization of the process robustness & cost efficiency.
- Filter application optimization: development of a process-/sterile filter risk evaluation tool for indication of high-risk applications
- Operational Excellence Champion Bacterial & Sterile Operations
- Certification as LeanSixSigma BlackBelt based on the finance approved savings of > 1 Mio. €
- Significant optimization of the process robustness as result of the BlackBelt projects by e. g. introduction of control charts (statistical process control), development of an innovative CAPA Effectiveness Tool
- Establishing of OpEx culture on site
- Introduction of
o 5S methodology in aseptic and bulk production areas
o visual boards for KPI tracking and communication
- Substitution of the Site MasterBlackBelt
Head of production & Process expert Formulation and Fill & Lyophilisation of human vaccines
- Significant optimization of the process robustness by optimized Root Cause Analysis & CAPA definition
- > 10 successful MediaFills
- Successful support of the site-wide FDA warning letter remediation program
Head of production aseptic filling and lyophilisation of human vaccines
- Introduction of a new lyophiliser
- Output increase including shift model change from 1- to 4 (24/7)
- Significant optimization of aseptic operations by e. g. introduction of a new, innovative helmet system for CRCA/B areas in own area and site-wide
- Optimization of the environmental monitoring (EM) in close collaboration with the QC department by e. g. application of the FMEA methodology: 70 % reduction of EM deviations
- Remediation of a Media fill fail

Good Manufacturing Practices, Lean Prozesse, Lean Startup, Produktionsleitung

8/2000 – 9/2006

Head of biological raw material purchasing
- Systematic listing & prioritization of site-wide biological raw materials required
- Optimization of purchasing processes (human blood donation; purchasing of human placenta)
Head / Value stream Manager of a process family of the Hemostasis unit
- Setting up of the cross functional team from bulk production to final packaging successful achieving of the targets in lead time, stock, and budget reduction (annually -8%)
Head of labeling & final packaging certified by German authority (Herstellungsleiter nach §15 AMG)
Head of labeling and final packaging of diagnostic reagents
- Introduction of an online-printing system based on SAP data & application of the Kaizen breakthrough methodology (e. g. exchange of manual conveyer belt kit assembly by u-shape workstations)
Head of Quality Assurance logistics
- Inspection readiness – successful initial audit of the German authority in 02/2001 without a major observation

Chemie, Good Manufacturing Practices, Lean Prozesse, Produktionsleitung, Projektleitung / Teamleitung

4/1996 – 7/2000

- Successful introduction of a new Eloxal line (chemical treatment of aluminum surfaces)

Chemie, Produktionsentwicklung

1/1996 – 3/1999

Scientist manufacturing support & technology for optical glasses (melting development)
- Optimization and introduction of a new continuous melting plant for special filter glasses

Chemie, Produktionsentwicklung