Marcel P.
interim Head of Production, CAPA-Manager, Expert in Process Optimization
Experience
Apr 2025 - Nov 2025
8 monthsGermany
CAPA/Deviation/OOS Manager Solid Production
Haupt Pharma Wülfing GmbH – Member of the Aenova Group
- Independent handling of deviations
- Independent handling of CAPAs
- Analysis of production OOS – evaluation and closure
- Technical advice in operations
- Complete revision of CPV – SOP, plan, report
- Development of coaching materials for production staff
Aug 2024 - Dec 2024
5 monthsGermany
Head of Solid Manufacturing
Miolma Consulting GmbH
- Head of manufacturing according to AMWHV and EU-GMP guidelines
- Responsible for creating and training on SOPs, MBRs, and other GMP/ISO relevant documentation
- Ensuring and reviewing correct batch documentation as well as other quality records (e.g., risk analyses)
- Preparation and approval of manufacturing instructions and documents
- Implementation of CAPA actions from deviations, customer complaints, and audits
- Analysis and interpretation of process data and continuous process improvement
- Responsible for staffing, equipment, customer support, and achieving the department's financial objectives
- Ensuring successful approval by European authorities and customers
- Subject matter expert for the responsible quality processes
- Consulting on the validation of manufacturing processes
- Representing the area of responsibility to customers and authorities
Feb 2024 - Jul 2024
6 monthsGermany
Head of Sterile Production
Klosterfrau Berlin GmbH
- Head of manufacturing according to AMWHV and EU-GMP guidelines for sterile production
- Advising production to ensure GMP-compliant manufacturing
- Evaluation of deviation reports
- Preparation and approval of manufacturing instructions and documents
- Conducting training and developing GMP guidelines for production
- Analysis and interpretation of process data and continuous process improvement
- Coordinating assigned staff to ensure product quality
- Ensuring successful approval by European authorities and customers
- Subject matter expert for the responsible quality processes
- Consulting on the validation of manufacturing processes
Sep 2023 - Jan 2024
5 monthsGermany
Head of ODF Manufacturing
Gen-Plus GmbH & Co. KG
- Ensuring timely planning, production, and supervision of manufacturing activities according to AMG, AMWHV, and EU-GMP guidelines
- Responsible for creating and training on SOPs, MBRs, and other GMP/ISO relevant documentation
- Ensuring and reviewing correct batch documentation as well as other quality records (e.g., risk analyses)
- Initiating, implementing, and leading manufacturing-related projects
- Collaborating on and handling internal and external complaints and deviations
- Implementation of CAPA actions from deviations, customer complaints, and audits
- Approval and monitoring of changes through the change control process
- Responsible for qualifying equipment and facilities and validating processes
- Responsible for staffing, equipment, customer support, and achieving the department's financial objectives
- Representing the area of responsibility to customers and authorities
- Responsibility for occupational safety, health, and environmental protection processes
Apr 2023 - Aug 2023
5 monthsGermany
Project Manager Process Optimization Packaging/Product Launch of Controlled Substances
Develco Pharma GmbH
- Optimizing production processes in packaging to ensure timely product launch
- Revising the planning concept for optimal line utilization
- Improving the training system for packaging
- Carrying out procurement activities
- Resource and budget planning
- Responsible for all operational planning, execution, control, and implementation of controlled substances launch projects
- Setting objectives and creating project plans
- Tracking timelines internally and externally
- Conducting project meetings
- Reporting to the Steering Committee
Apr 2021 - Mar 2023
2 yearsGermany
Tech Transfer Manager OEB 4/OEB 5/Project Manager
R-Pharm Germany GmbH
- Conducting process risk analyses and site-by-site analysis for product transfer in an interdisciplinary, cross-functional project team
- Creating transfer protocols and reports including defining Design of Experiments (DoE)
- Overseeing tech trials, verification batches, and validation batches
- Evaluating and documenting results
- Planning and scheduling trials and ensuring machine capacity in coordination with the head of manufacturing
- Planning and coordinating material requirements and staffing
- Training employees on transfer activities
- Responsible for all operational planning, execution, control, and implementation of OEB 4/5 tech transfer projects
- Budget planning
- Setting goals and creating project plans
- Tracking timelines internally and externally
- Conducting project meetings
- Reporting to the Steering Committee
Nov 2020 - Feb 2021
4 monthsGermany
Production Coordinator
R-Biopharm AG
- Coordinating production and improving processes for SARS-CoV-2 test systems
- Increasing production efficiency by streamlining workflows and improving staff flexibility
- Revising manufacturing instructions
- Providing technical and disciplinary leadership for 32 production staff
- Resource and budget planning
- Introducing two semi-automatic filling lines and redesigning the material flow
Oct 2019 - Sep 2020
1 yearSpain
Interim Head of Production
Hanna Healthcare S.L.
- Successfully scaling up a new API for pellets using a bottom-spray process from development scale to commercial batch size
- Optimizing the spray process to reduce yield losses by defining spray parameters
- Developing the validation plan and performing process validation
- Preparing manufacturing instructions
- Training operators on the new spray process
- Resource and budget planning
- Providing technical and disciplinary leadership for 14 production staff
- Carrying out procurement activities
- Developing and implementing a new zoning concept for material and personnel flow due to COVID-19
Oct 2017 - Sep 2019
2 yearsSwitzerland
Head of Production
Konapharma AG
- Increasing production efficiency by 30% through streamlining workflows and improving staff flexibility
- Reducing manufacturing costs by 15% by improving planning and control processes
- Optimizing product transfers and ensuring timely product launches
- Reducing production deviations by 45% by revising manufacturing instructions and improving the training system
- Lowering department absenteeism by 30% by boosting employee motivation
- Enhancing workplace safety through regular inspections
- Carrying out procurement activities
- Providing technical and disciplinary leadership for 36 production staff
- Preparing and conducting internal and external audits, reducing findings by 25%
- Resource and budget planning
Jan 2009 - Sep 2017
8 years 9 monthsGermany
Deputy Head of Production
Hennig Arzneimittel GmbH & Co. KG
- Assuming all responsibilities as acting head of manufacturing with personnel responsibility for 28 staff
- Ensuring compliance with quality, deadline, and cost requirements
- Improving workplace safety
- Preparing and conducting internal and external audits
- Training employees
- Planning and controlling production processes
- Participating in quality circles
- Approving manufacturing instructions and ensuring compliance
- Optimizing production workflows
- Conducting product transfers
- Approving and ensuring compliance with SOPs
Sep 2007 - Dec 2008
1 year 4 monthsGermany
R&D Engineer
Losan Pharma GmbH
- Development of stick pack formulations
- Evaluation and co-development of a testing device to check the tightness of primary packaging/stick packs in collaboration with Nolek SE
- Conducting, analyzing and documenting experiments to develop innovative solid dosage forms
- Performing scale-up trials
- Carrying out equipment qualifications
- Administrative tasks
Languages
German
NativeEnglish
AdvancedSpanish
ElementaryEducation
Oct 2003 - Aug 2007
Fachhochschule Albstadt-Sigmaringen
Diploma in Engineering · Pharmaceutical Engineering · Germany
Sep 2000 - Jul 2003
Pfizer GmbH Arzneimittelwerk Gödecke
Pharmaceutical Technician · Freiburg im Breisgau, Germany
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