Greater Minneapolis-St. Paul Area
“We cannot direct the wind, but we can adjust the sails.” I help pharma companies and OEMs avoid costly CAPEX failures in aseptic fill-finish ... often before they become visible. 25+ years in pharmaceutical equipment engineering, isolator technology and global project execution. Deep involvement in 25+ large-scale isolator fill-finish lines and 100+ hands-on installations worldwide. Focus areas: Aseptic Manufacturing | Annex 1 | Isolators | CAPEX Risk & Governance | Market Entry Americas. Independent perspective. No OEM bias. Focused on risk, execution and what actually works in reality. Founder & Principal, Pharma-Technology-Consulting, LLC | 2020 – Present Director, Turnkey Projects & New Technologies, Bausch+Ströbel | 2024 – 2026 Senior Consultant / Product Specialist – Aseptic Transfer Systems, Sartorius North America | 2021 – 2024 Product & Process Specialist – Barrier Systems / Isolators, Bosch Packaging Technology & Syntegon | 2017 – 2021 Global Engineering & Standardization Lead, Bosch Packaging Technology (HQ Germany) | 2013 – 2017 Earlier Career (Bosch Packaging Technology), Software Engineering | Validation | Quality | Assembly | 1999 – 2013
Independent CAPEX Risk & Governance Advisor | Aseptic Fill-Finish | Annex 1 | Isolators | Aseptic Manufacturing | Market Entry Americas. I help pharma companies and OEMs avoid costly CAPEX failures in aseptic fill-finish ... often before they become visible. 25+ years of experience across isolators, Annex 1 and global Tier-1 projects. Independent. No OEM bias. Focused on risk, execution and decision-making.
I guide pharmaceutical manufacturers in strategically expanding their operations across North America by aligning advanced aseptic platforms with emerging biotech and cell & gene therapy innovation. Senior Consultant Fill & Finish Projects, GMP Expert, Regulatory Compliance Assurance, Customer Relation, Business Development, Sales Expert, Market Expert for North-/South America, Pharma Manufacturing Process-, Isolator Technology-, Inspection-, Filling Equipment- Expert.
Product Management / Sales / Senior Consultant - for final filling, aseptic transfer systems, PUPSIT, single-use, ready-to-use applications, Barrier Systems, EU GMP Annex 1, Leadership, Strategic Growth, Budget Responsibility,.. for North- and South America (Americas). Publications: - Cutting Edge of Aseptic Transfer Technology - Best possible Annex 1 compliance of single-use for F&F - Benefits of Single-Use Technology - Benefits of single-use technology in final-filling in regards of ATMPs - ADCs & state-of-the-art fill-finish technology - Benefits of single-use for ATMPs in regard to Annex1 - Insights into state-of-the-art isolator technology PDA Letter Publication (Contributions to PDA Workgroup, lead by Richard Denk, SKAN AG): - Points to consider for the commercial manufacturing of ATMPs
- Technical sales specialist, market research and analysis, business development, product promotion, marketing, process development & engineering consulting with focus on fill-finish solutions, isolator and containment technology, aseptic filling machines and processes. Presenter for isolator and containment isolator solutions. Technical discussions and consultancy about aseptic processes, transfer technology and barrier system. Trainings, service and process support. Certified project manager, team coordinator in sales, engineering and service activities. Product management, product improvement and customer satisfaction. Founder of the Syntegon Connect knowledge platform: "Barrier Systems and Processes in Aseptic Environment". Key Accounts: BMS, Merck, Sun Pharma (Pharmalucence), American Regent (PharmaForce, Luitpold), Green Cross, Fresenius Kabi, Lab. Pisa, Eli Lilly, ... Publications: - A history review and guide to barrier systems - Syntegon Pharma Blog - ADCs & state-of-the-art fill-finish technology (for high potent drugs) - ISPE - How will Annex 1 change fill/finish processes? - Pharmaceutical Technology
- Technical sales specialist, market research and analysis, business development, product promotion, marketing, process development & engineering consulting with focus on fill-finish solutions, isolator and containment technology, aseptic filling machines and processes. Presenter for isolator and containment isolator solutions. Technical discussions and consultancy about aseptic processes, transfer technology and barrier system. Trainings, service and process support. Certified project manager, team coordinator in sales, engineering and service activities. Product management, product improvement and customer satisfaction. Founder of the Bosch Packaging Technology connect knowledge platform: "Barrier Systems and Processes in Aseptic Environment" Key Accounts: BMS, Merck, Sun Pharma (Pharmalucence), American Regent (PharmaForce, Luitpold), Green Cross, Fresenius Kabi, Lab. Pisa, Eli Lilly, ... Publications: - The Fine Art Of Transferring Products Into Barrier Systems - Pharmaceutical Processing World - Insights into state-of-the-art sterile fill finish applications for aseptic and highly potent drugs - ISPE - Mini White Paper: Changeover on a Bosch Packaging Isolator Line - Mini White Paper: Qualification and Validation of Isolator Systems - Bosch Wireless Glove Tester: Solutions & Advantages - Bosch Isolators: Continuous Improvement based on long term experience