Robert currently serves as the acting VP of Quality at ECI Pharma, a non-sterile, solid oral dosage manufacturing site in Ft. Lauderdale, FL. He also holds the same capacity with BioRamo LLC, the sister facility where liquids and creams are produced. The quality group is responsible for monitoring & assuring product quality of the solid oral (tablets and capsules) and liquid dosage products manufactured at the two sites. The quality group oversees the production and operational processes to ensure that all activities adhere to internal and regulatory guidelines.   From January 2017 to August 2020 Robert served as the V.P. of Compliance at ECI Pharma and BioRamo LLC.  Robert shares responsibilities with the Director of Quality for supervising (7) quality associates and served as team lead in work groups responsible for designing, constructing and qualifying a dedicated hormone manufacturing suite. In addition, Robert was actively involved in the installation and qualification of a new fluid bed dryer and automated tablet coating machine as well as a new packaging line equipped with serialization and aggregation.  

While working at FDA Robert conducted many solid oral dosage inspections both domestically and abroad. In addition, Robert worked with another Mid-Atlantic Regional Drug Specialist and prepared a handbook entitled; “Solid Oral Dosage Manufacturing Issues and Concerns” for new investigators that was presented to the attendees at one of FDA’s Regional Drug Schools where Robert also served as an instructor. Course material included: pharmaceutical manufacturing terminologies, design and content of a BPR (batch production record), maintenance and control of tablet tooling, in-process testing requirements, blend uniformity issues, design of process validation protocols and QC laboratory inspection procedures. 

When Robert was a Supervisory Drug Investigator, he used the curriculum from the FDA National Basic Drug School to create and conduct a one-week district drug school training program for several newly hired drug investigators.  Robert worked with a local drug manufacturer that agreed to conduct plant tours, in addition to presenting a formal cGMP (current good manufacturing practices) training session as part of the new hire training.  

For several months, Robert served as the team lead on a comprehensive solid oral dosage inspection that identified cGMP issues along with data integrity issues that subsequently resulted in the firm entering a consent decree, voluntarily discontinuing all manufacturing, initiating recalls of many affected products, and withdrawing several ANDAs. Robert then served as one of the compliance officers responsible for reviewing the manufacture’s AIP (application integrity plan).  After several revisions and site audits, the company received CDER approval of the AIP. 

In 2006, while working as a consultant, Robert spent the entire year at a large sustained-release dosage manufacturer in south Florida where his duties included coaching deviation writers in conducting more thorough investigations. Robert provided training to improve root cause analysis and instituting effective CAPAs to help prevent the reoccurrence of deviations. Robert also performed on-floor manufacturing QA oversight and worked with another consultant in drafting process validation (PV) protocols for several products. 

Other consulting responsibilities included: assisting a solid oral dosage manufacturer develop an effective remediation plan for previously cited FD-483 deficiencies, then accompanying firm management to a CDER meeting where his remediation plans were accepted by the Agency. The improvements and GMP corrections reported to CDER were subsequently verified during a follow-up regulatory inspection where only minor FD-483 items were found and resulted in a satisfactory inspection.

Robert remains current with FDA & DEA regulatory requirements, SUPAC guidelines and available industry guidance documents for solid oral dosage manufacturing activities.