About James Funk
I run Funk Consulting Group, a consulting practice for 503B outsourcing facilities. I work with founders building a facility from scratch and with existing operators who are expanding or responding to an FDA inspection.
My background is hands-on. I was the founding employee at ProRx, a 503B outsourcing facility, where I helped bring sterile manufacturing online, build out the facility and bring in new clients. I also teach biopharmaceutical manufacturing as a BioTrain Fellow at Purdue, giving lectures and labs for undergraduates, graduate students and industry professionals.
Alongside this work I am finishing a PhD at Purdue in industrial and molecular pharmaceutics, where I study how permeation enhancers interact with peptides to improve oral bioavailability.
The consulting work
I work with companies starting a 503B from scratch and with existing facilities that are expanding or fixing problems found in an inspection. The work usually covers regulatory strategy, product selection, site design and build-out, quality systems, and the SOPs and operator training the facility runs on.
On regulatory and inspection work, I work directly with former FDA investigators, so clients get a view of their facility from the agency's side of the table.
Building a 503B from the ground up
I was the founding employee at ProRx, a 503B outsourcing facility. Joining before anyone else meant working on every part of getting the facility running, not just one function.
- Bringing sterile manufacturing onlineHelped take sterile production from plan to operating facility.
- Facility build-outWorked on building out the site as the company grew.
- Client developmentBrought in new clients for the facility's products.
That experience is the basis for this practice. I have seen firsthand which early decisions make a 503B easier to run, and which ones become expensive later.
Teaching biopharmaceutical manufacturing
I am one of the seven inaugural fellows in Purdue's BioTrain program, part of the Heartland BioWorks Tech Hub, which is building Indiana's biopharmaceutical manufacturing workforce. As a fellow I teach the subject directly.
- Lectures and hands-on labsTeaching biopharmaceutical manufacturing to undergraduates, graduate students and industry professionals.
- Curriculum and mentoringBuilding lesson plans, lab sessions and assessments, and mentoring undergraduates working toward a Pharmaceutical Manufacturing certificate.
BioTrain is a partnership of Purdue University, Heartland BioWorks, BioCrossroads and Ivy Tech Community College. Read Purdue's announcement.
Background
- Founding Employee, ProRx503B outsourcing facility: sterile manufacturing start-up, facility build-out and client development.
- PhD Candidate, Purdue UniversityResearch on how permeation enhancers interact with peptides to improve oral bioavailability.
- BioTrain Fellow, Purdue University and Heartland BioWorksInaugural cohort, teaching biopharmaceutical manufacturing.
Get in touch
If you are starting a 503B or trying to improve one, I'd like to hear about it.