About me

I am Kai Hasler, owner and operator of Black Field Consulting. I have been a professional serving the pharmaceutical industry for over 20 years, including more than 17 years’ experience working with organizations dedicated to parenteral contract manufacturing. My clients range from virtual companies to global pharmaceutical corporations. My professional experience includes directing aseptic operations for manufacturing high-potency liquids, lyo products, and powders for the global market.

A graduate engineer, technology comes easy to me. I have developed robust processes, created precise assessments and am always on the lookout for process improvements. My education also includes studies in business administration and management.

I bring my experience and proficiency to the following areas:

• Project management: Tech Transfer of sophisticated parenterals, from clinical stages (phases I, II, III) to commercial supply on global markets (EU, US, JP, …) – PMI® (Project Management Institute) compliant
• Requests for proposals (RFP)
• Process definition (including primary packaging materials)
• Proposal generation
• Contracting
• Process transfer
• Filing preparation
• Regulatory inspection/approval

Further experience includes aseptic manufacturing operations, assuming responsibility for quality, overhead and staff while consistently applying LEAN tools throughout the project.

Rounding things off, I have in-depth experience with validation and qualification requirements, successfully erecting an entirely new production site with two aseptic filling lines for lyophilized products.

Of course, I am well-versed in the ins and outs of CMOs and the unique challenges they pose (conflicting goals, diverse company cultures and communication styles, etc.). I’d be happy to guide you through the maze.

Located in Central Germany, I have convenient access to air and land travel, be it continental or global.