Joseph Tunner

I have 30 years of experience working in a GMP environment with pharmaceutical products and diagnostic devices.  My areas of expertise include commercial manufacturing plant design and construction, and the process transfer and manufacturing of both sterile parenteral products (liquids and gels) and non-sterile oral solid dose products.  I am experienced with the use and qualification of the associated equipment and facilities and the design and qualification of support processes such as sterilization and cleaning.  I have both managed a technical staff and worked in a team-based environment for on time on budget completion of process, product, equipment, and facilities related goals.  Have successfully defended areas of responsibility (validations, facilities, engineering, and manufacturing) through regulatory inspections (FDA PAI and FDA/EMA/MHRA commercial).  Lastly, I have managed the maintenance and capital upgrades of a multi-building pharmaceutical and R&D site with an annual operating budget in excess of $10M.

Specialties: Pharmaceutical parenteral and solid drug product development, engineering, facilities, utilities, and manufacturing.

My career has been in the pharmaceutical sector with experience in the development of aseptically prepared Pharmaceutical Injectables, Solid Doses, as well as with Medical Devices.

I am a technical leader who has directed groups of Process Engineers, Facilities Engineers, Manufacturing Engineers, Technical Scientists, Validation Engineers and, most recently, a Facilities / Facilities Engineering Department with 27 positions.  I have successfully completed the design and construction of clean room suites, laboratories, warehouses, and offices, ranging from $6 to $25 million, and have supervised key engineering teams on much larger projects.  This included the design, fabrication, automation, start up and qualification of complex aseptic manufacturing process equipment.

In addition to leading groups, I have the ability to execute substantial projects without a direct reporting structure.  For instance, my largest project, where I designed and built bulk cell culture and sterile fill finish clean room suites, including support laboratories and a separate office build-out, was executed with no staff.  This project showcased my ability to network with all stakeholders at a pharmaceutical company to design and execute a project that met the needs of various departments, including Manufacturing, Facilities, QC, QA, R&D, and Office Management, all while staying within a company designated budget.

Ph.D., Chemical Engineering, Standford University

BS, Chemical Engineering, University of Colorado, Boulder