plus2you GmbH - Berater der Pharmaindustrie

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

Quality and Compliance is at the core of everything we do. We offer comprehensive and in-depth expertise regarding Quality Planning, Assurance, Control and Improvement.

Strategy

Quality Commitment / Policy
Quality Mgmt. Systems
Quality Planning

Structure

Audits / Self Inspections
Quality Inspection Readiness
Remediation Activities

Process

Deviation Management
KPI Definition / Tracking
Supplier Qualification

Finance

With our experience that combines Financial and Business Management Skills with Technical Capabilities, we support our customers’ businesses as needed and in their best own interest.

Strategy

Strategy Development
Business Case Evaluations
Make vs. Buy Analysis

Structure

Performance Management
COGS Analysis / Roadmaps
Credit Appropriation Support

Process

Budgeting
Monthly Reporting
Variance Analysis

From pharma industry practice, we understand your needs.

Feel free to
reach out to us.

plus2you GmbH
Bierastrasse 36
4103 Bottmingen
Switzerland
www.plus2you.ch

Dr. Thomas Schwarz

Helge Leibfritz

contact@plus2you.ch

DATENSCHUTZ | IMPRESSUM