Curriculum Vitae

Frank Generotzky

Vorstandsmitglied & Chief Operating Officer

Wedel, Deutschland

Professional Summary

Accomplished pharmaceutical executive with over 25 years of progressive international experience in global operations management, strategic leadership, and regulatory compliance. Currently serving as Board Member (Vorstandsmitglied) and Chief Operating Officer at medac GmbH, while simultaneously holding the position of Senior Director Global Pharmaceutical Operations at Baxter International Inc.

Proven track record in leading complex pharmaceutical operations across multiple continents, with deep expertise in aseptic manufacturing, cytotoxic drug production, and implementing world-class quality systems. Successfully managed investment projects up to €54 million and led teams of up to 63 professionals. Distinguished background in operational excellence, Lean Management, and driving organizational transformation in highly regulated environments.

Professional Experience

Chief Operating Officer (Vorstandsmitglied)
medac GmbH
Wedel, Deutschland
Oktober 2020 - Heute (5+ Jahre)
  • Member of the Executive Board (Vorstandsmitglied) with full operational responsibility
  • Overall responsibility for global pharmaceutical operations and manufacturing
  • Strategic planning and execution of operational excellence initiatives
  • Leadership of production, technology, quality assurance, and supply chain functions
  • Development and implementation of corporate strategy for pharmaceutical operations
Senior Director Global Pharmaceutical Operations
Baxter International Inc.
Unterschleißheim, Deutschland
November 2019 - Heute (6+ Jahre)
  • Directed global pharmaceutical operations across multiple continents
  • Managed complex manufacturing networks and production facilities
  • Led supply chain optimization and operational efficiency projects
  • Ensured regulatory compliance across all global operations
  • Implemented quality systems and GMP standards worldwide
Standortleiter und Cluster Lead EMEA
Baxter Oncology GmbH
Halle, Deutschland
April 2016 - Januar 2020 (3 Jahre 10 Monate)
  • Technical Managing Director for Production, Technology, and Supply Chain
  • Overall responsibility for Technology, Quality, Delivery dates, and Manufacturing costs
  • Led optimization of sterile manufacturing at India plant (since August 2017)
  • Expanded responsibility to 5 additional factories in EMEA cluster (since August 2019)
  • Drove operational excellence across multiple manufacturing sites
Director Technology & Engineering
Baxter Oncology GmbH
Halle, Deutschland
Juni 2007 - März 2016 (8 Jahre 10 Monate)
  • Led Technology and Engineering departments for Halle manufacturing site
  • Managed team of 29 specialists/technicians and 24 engineers
  • Executed investment projects ranging from €100,000 to €54 million
  • Process planning and optimization for aseptic manufacturing operations
  • Facility Management responsibility for entire site
  • Led Environmental Protection, Occupational Safety, Plant Security, and Fire Brigade departments
  • Selected and coordinated external service providers for site operations
Manager Manufacturing Cytotoxics
Baxter Oncology GmbH
Halle, Deutschland
Januar 2001 - Juni 2007 (6 Jahre 6 Monate)
  • Operational management for newly established isolator operation
  • Responsible for aseptic manufacturing of parenteral cytostatic drugs
  • Successfully transitioned 3 production lines from project to routine production
  • Technical and disciplinary leadership of 63-person team
  • Economic planning and production control responsibilities
  • Pioneered Lean Management implementation in aseptic manufacturing area
Projektmanager
ASTA Medica AG
Deutschland
Juli 1999 - Januar 2001 (1 Jahr 7 Monate)
  • Process planning and implementation for aseptic filling in isolator and cleanroom technology
  • Commissioning, qualification and validation of aseptic production equipment
  • Compliance with EU and FDA guidelines for pharmaceutical manufacturing
  • Presented new concepts at industry conferences and to customers and regulatory authorities
Prozessingenieur für Qualifizierung, Revalidierung und Inprozesskontrolle
ASTA Medica
Deutschland
September 1998 - Januar 2000 (1 Jahr 5 Monate)
  • Disciplinary and technical leadership of 20 pharmaceutical technicians
  • Monitoring and quality assurance of cleanroom air quality
  • Standardization of production facility revalidation processes
  • Enforcement and monitoring of customer and regulatory requirements
  • Led department restructuring within pharmaceutical production organization
Prozessingenieur Produktion Parenteralia
ASTA Medica AG
Deutschland
März 1996 - August 1998 (2 Jahre 6 Monate)
  • Process engineering for parenteral drug manufacturing
  • Performance and process optimization through process and risk analyses
  • Project management for new facilities with German and Italian equipment manufacturers
  • Installation, commissioning and qualification of aseptic production facilities
  • Presented facilities and processes to regulatory authorities and customers

Education

Master of Business Administration (MBA)
University of Louisville
USA
Mai 2010 - August 2011
Focus: Global Business
Managerial EconomicsOrganizational BehaviorManagerial AccountingOperations Design AnalysisMarketing and Distribution ManagementLeadership & EthicsGlobal BusinessInnovation & New Product DevelopmentNew Venture and Business Plan Development
Diplom-Ingenieur (FH)
Fachhochschule Lippe und Höxter
Deutschland
August 1992 - März 1996
Focus: Life Science Technologies
Lebensmitteltechnologie

Core Expertise

Operations Management
  • Global Pharmaceutical Operations
  • Manufacturing Excellence
  • Supply Chain Management
  • Production Planning & Optimization
  • Lean Management
  • Operational Strategy Development
  • Facility Management
Leadership & Strategy
  • Executive Board Leadership (Vorstand)
  • Strategic Planning & Execution
  • Change Management
  • Team Leadership
  • Strategy Deployment
  • Organizational Development
  • Project Management
Quality & Compliance
  • GMP Compliance
  • Quality Management Systems
  • Regulatory Affairs
  • Qualification & Validation
  • FDA/EMA Inspections
  • Quality Assurance & Control
Technical Expertise
  • Aseptic Manufacturing
  • Process Engineering
  • Cytotoxic Drug Production
  • Isolator Technology
  • Cleanroom Technology
  • Equipment Qualification & Validation
  • Pharmaceutical Engineering

Languages

Deutsch
Muttersprache
Englisch
Fließend

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