As Product Development (PD) Scientist (collectively between Hikma and Boehringer-Ingelheim Roxane Laboratories), my projects have successfully received FDA tentative or final approval on several new drug product applications (ANDAs) as well as numerous PAS and CBE filings. My formulation experience includes immediate, delayed, and extended release oral tablets and capsules, solutions, and nasal spray and ophthalmic suspensions.Throughout my collective time in PD, I have served as one of my department’s primary contacts for overseeing process equipment capital projects, operating as project manager for most equipment projects valued at less than $200K. Additionally, I act as my department’s interface for other aspects of equipment lifecycle such as validation/qualification, change management, decommissioning, periodic reviews, and asset transfer. Working with equipment vendors, the quality organization, and validation, project, process, and automation engineers has kept me grounded in current regulatory expectations and engineering principles. (continued to Scientist IV, Product Development at Boehringer-Ingelheim)

Note: The sale of Boehringer-Ingelheim Roxane Laboratories to Hikma Pharmaceuticals was complete in March 2016.(continued from Scientist IV, Product Development at Hikma Pharmaceuticals) The best part of PD has been the close connection to all parts of the business. It's been rewarding to drive new drug product projects to completion with team members from across the organization. Use of my Project Management Certification has been especially useful in managing these projects. My ability to learn diverse technologies is among my greatest strengths. I have developed products using wet and dry granulation, tablet compression, encapsulation, film coating, bead milling, Wurster drug layering, extended release bead coating, mini-tablet enteric coating, hot-melt extrusion, and aseptic processing.Condensing an almost infinite number of possible formulation/process combinations down to one which is manufacturable, stable, non-infringing, and bio-equivalent is both challenging and rewarding. I find using QbD principles of risk assessment and DOE especially useful. I love to experience the iterative nature of development play out as I respond to both expected and unexpected in vitro and in vivo results.I like the hands-on aspect of development and for that reason I manufacture and package almost all my development formulations and all small scale GMP clinical supply batches for my products. I also perform most physical evaluations as well.

In Production Technology, my attention was focused on new/existing process validation, product lifecycle support, tech transfer, process engineering, and equipment validation. The bulk of my time was spent providing technical solutions to challenges and opportunities in the aseptic Blow-Fill-Seal filling area including CIP and SIP process development and validation, In-Batch recipe programming, media fill validation, class 100 area and class 10,000 clean room design, sterile gowning, directional airflow verification, and identification and correction of filling process and purified water system microbiological contamination issues. It was exciting to work on large capital projects such as the complete liquid manufacturing process center re-design which took place while in PT. There I worked on a team to establish user and functional requirements (URS & FS) followed by execution of OQ and PQ elements once built. I also played a crucial role in CIP process optimization for this project which was quite rewarding.

I joined Boehringer-Ingelheim Roxane Laboratories in December 1998 as part of the Technical Services organization and remained in that position for approximately 2 years. I was able to learn nuances of pharmaceutical oral dosage form unit operations and formulations, industry regulations, and quality systems. Cleaning Validation (CV), Annual Product Reviews (APR), deviation investigations, change management, new/existing process validation and tech transfer, CIP process support and development, and equipment validation were among my responsibilities.

After three years in the centralized Process Engineer role, I accepted a position as Plant Process Engineer at the Zeeland, MI facility where I was responsible for lifecycle support and tech transfer. The timing of my new assignment corresponded with the start-up of a new $140 million powder process facility. Much of my initial attention was spent solving plant start-up hiccups jointly with operators, equipment vendors, and project and automation engineers in liquid processing and homogenization, evaporation, drying, and powder blending areas. It was gratifying to eventually see the processes work efficiently as originally intended.Other focus areas were to improve process yields, increase plant capacity, and continue to provide upstream and downstream bio-process technical support.

As engineer in the corporate centralized Process Engineering group, I worked very closely with R&D, manufacturing, and quality groups in the technical transfer and general lifecycle support of new and reformulated infant formula products to both internal process centers as well as contact manufacturing organizations (CMOs). I served as the primary contact for the hypoallergenic product lines, including support of both the upstream bioreaction and downstream purification processes. Working with R&D and medical researchers to scale-up and commercialize new formulations and processing methodologies was a great experience. It was an honor for me to represent Process Engineering on the first Process Analytical Technology (PAT) team in which we experimented with and later implemented Near Infrared (NIR) in-line with real time feedback to ensure product quality.