40+ years of Pharma and Biotech Expertise
Deep Experience in Operations, Quality and Finance
International Leadership Acumen
Well-Established Network in the Industry
Dr. Thomas Schwarz, MBA
Managing Partner
Curriculum
Head Customer Liaison & Quality Strategy (Allschwil) – Skan
- Business Development for Aseptic Manufacturing Services
Chief Commercial Officer (Auburn, Basel) – SiO2 Materials Science
- Sales and Marketing of Novel Primary Packaging Components (Vials, Syringes)
- Global Re-Branding
Strategy and Business Excellence (Zürich) – Takeda
- GMS Global Strategy (Biologics, Small Molecules, Plasma)
- Long-term COGS Modelling
TechOps / Tech Dev (Stein, Basel, Vacaville) – Novartis
- Aseptic Manufacturing (Vials, Syringes)
- Microbial Fermentation and Downstream
- Quality Control of APIs
- Supply of Clinical Trials
- Global Biologics Strategy
Biotechnology (Frankfurt) – Sanofi
- Recombinant Insulin Manufacturing
- MES Implementation
- Project Management
Experience and Capabilities
- Large-Scale Fermentation and Purification of Recombinant Proteins
- Aseptic Manufacturing including Combination Products (Vials, PFS)
- MES Implementation
- Leadership of Large Operational Units
- Quality Control / Assurance: >10 FDA Inspections (Front Office)
- E2E Clinical Supply Chain / Late Stage Customization
- Long Term Strategy & Benchmarking (Biologics, Biosimilars)
- Business Case Evaluations (Investments, Outsourcing, BD&L)
- Modelling of Long-Term COGS Development
- Sales and Marketing of Unique Primary Packaging Containers
Helge Leibfritz, BSc, MBA
Managing Partner
Curriculum
Contract Development (Basel, Visp) – ten23 health
- New Manufacturing Facility Design
- Stability / Toxicological Study Supplies
- Primary Packaging Material and Device Testing
External Manufacturing, Tech Transfer, Quality and Tech Dev (Basel) – F. Hoffmann-La Roche
- Device & Packaging Development
- Tech Transfer
- Biologics MSAT Drug Product
- QA Quality Systems & Validation
Parenterals Production (Laupheim) – Rentschler Biotechnologie
- Aseptic Drug Product Contract Manufacturing
Tech Dev, Production, Quality and Finance (Basel, Stein, Mississauga, Liverpool) – Novartis
- QA Compliance and QA Release
- Finance Business Partnering
- Green Field Project – Sterile Production Facility
- QA Sterile Operations
- Aseptic Drug Product Manufacturing
Experience and Capabilities
- Aseptic Drug Product Manufacturing (Vials, Syringes, Cartridges)
- Device Assembly (NSDs, Autoinjectors, On-Body Injectors)
- Manufacturing Science & Technology (Sterile Drug Products)
- Tech Transfer and CMO Management (e.g. DEU, KOR)
- Quality Assurance (Biotech Drug Substance, Sterile Drug Product)
- Supplier / Material Qualification, Auditing and Self-Inspections
- GMP Inspections (BRA, CHE, DEU, JPN, MEX, GBR, USA)
- Facility / Equipment Design, Commissioning and Qualification
- Finance (Planning, Analysis, Reporting, Investment / Divestment)
Operations
We love being on the shop-floor, providing tailored hands-on support to customers for the multifaceted challenges that manufacturing processes in the GMP regulated field do provide.
Strategy
Competitor Analysis
BD&L / Due Diligence
Long-term Capacity Planning
Structure
CDMO Management
MES Implementation
Organizational Development
Process
Technical Development
Technical Transfer
Process Improvements
Quality
Finance
From pharma industry practice, we understand your needs.
From pharma industry practice, we understand your needs.