Nicholas Diorio

Manage Pre-Approval program for field evaluations of NDAs, ANDAs, NADAs, and ANADAs ensuring FDA compliance.

• Conducted complex inspections of domestic and foreign drug manufacturers, including sterile and OTC products.
• Conducted thorough investigations to gather evidence and facts for cases.
• Collaborated with law enforcement to support criminal investigations and case resolutions.
• Analyzed data and documents for inconsistencies and potential leads in cases.
• Prepared detailed reports summarizing findings for legal review and prosecution.
• Maintained accurate records of all investigative activities and findings securely.
• Trained junior investigators on best practices in conducting investigations thoroughly.
• Collaborated with local law enforcement agencies on criminal investigations.
• Developed case plans and conducted comprehensive investigation tactics to obtain necessary evidence.
• Trained and mentored field investigators and worked with team lead to identify skills, problem areas, and opportunities for staff development and improvement.
• Presented case summaries at team meetings for review purposes.

• Lead role that reported to the Laboratory Quality Control Manager.
• Responsibilities included the supervision and training of 10 Chemists and 3 Laboratory Technicians who were responsible for the testing and release of bulk raw materials and components used in manufacturing finished sterile drug products.
• Created workload schedules, implemented employee training programs, responsible for writing employee reviews, helped troubleshoot technical problems related to product release, communicated with upper management in all areas of raw material issues, involved in reviewing and approving alternate raw material and component vendors.
• Worked with FDA officials and overseas regulatory agencies who conducted facility inspections.
• Provided written responses to FDA 483s and other regulatory agency deficiencies related to my department of responsibility.
• Performed many other duties as described below:
• Gained substantial experience working within all aspects of a Quality Control Unit in an FDA regulated CGMP sterile injectable pharmaceutical manufacturing environment.
• Accomplishments and duties included conducting investigations and testing of our imported Heparin API raw material.
• Also conducted one on-site audit of our Heparin Supplier in China.
• This was in an effort to help alleviate the heparin drug shortage after the OSCS was found in a competing supplier of heparin drug products.
• Developed, implemented and validated new testing procedures that confirmed and differentiated between pure heparin and look alike contaminants.
• Developed, wrote and implemented analytical protocol studies and conducted further advanced testing that would introduce new methods of detecting contamination in heparin raw material.
• Active in the team of scientists that ensured all new test methods were employed on the heparin raw material upon receipt in the U.S. and also at the Active Pharmaceutical Ingredient (API) manufacturer/supplier.
• Primary contact for many of our overseas API suppliers.
• I worked with the overseas vendors to troubleshoot incoming API's that were found to be OOS.
• Many of the vendors were manufacturers from China.
• The API's included heparin, doxorubicin and cisplatin.
• Developed a strong working knowledge of the United States Pharmacopeia (USP) and have been proactive in communicating with USP personnel to interpret and clarify specific chapters and many test monographs.
• My work with the USP contributed to changes in USP monographs such as the Protamine Sulfate, USP assay.
• Other Duties:
• Performed routine chemical testing as per SOP’s and other test method compendium such as the United States Pharmacopeia and European Pharmacopoeia.
• Managed Testing procedures performed involve extensive wet chemistry methods and chromatographic analysis using HPLC, GC as well as other lab instrumentation (UV-VIS, FTIR, etc.) as required.
• Demonstrated considerable knowledge of analytical methods and a strong instrumentation background by effectively executing and implementing test method changes at all APP facilities as well as contract laboratories and API suppliers.
• Helped to ensure timely completion and resolution of OOS, OOT and IIR investigations, by using TrackWise Laboratory Investigations (TWLI) software.
• Written several training modules used within APP for demonstrating proper training documentation of new and experienced employees.
• Helped to ensure training documentation is up to date and that only trained analysts perform official testing.
• Provided ongoing training to other lab personnel at various position levels.
• This included new employee training and experienced lab personnel on CGMPs, Safety, new instrumentation, new procedures, hazardous material handling, MSDS, etc.
• Consistently updated and improved various company SOP’s using Documentum software.
• Supervised a selected group of analysts including new analysts in training.
• Performed a backup role to take over supervision of lab areas when supervisor was on vacation or absent.
• Involved in technical transfer of several new pharmaceutical drug products from pilot plant to full scale production.
• This experience included participating in Process Validation of the new drug products.

• Performed analytical test method development, and technical services, for a large portfolio of aseptically filled, and lyophilized ANDA sterile injectable drug products.
• Troubleshot and revised test methods as needed.
• In addition to performing this work on generic drug products, I also played a key role in the product development of the NDA product, ABRAXANE (paclitaxel protein-bound particles for injectable suspension, albumin-bound).
• Communicated plant issues and tasks with project teams with respect to scaling up processes, new equipment and procedures, equipment and process validation, manufacturing of development, stability, and product validation batches.
• Helped to coordinate the preparation of the manufacturing site for the manufacture of new products.
• Communicated as necessary with the various plant departments, other support departments, project team members, and own department.
• Helped to prepare master batch records and protocols for the manufacture of development, stability, and validation batches.
• Assisted in translating development findings into the manufacturing processes.
• Identified and helped to implement practices and procedures designed to provide robust manufacturing processes.
• Provided information and documentation needed for regulatory submissions or responses as required.
• Conducted scale-up evaluation and support, as needed when manufacturing or analytical testing discovered technical deficiency issues.
• Provided technical assessment of changes in manufacturing through appropriate review of documentation and testing results.
• Assisted in developing and executing necessary investigative studies and validation protocols as required.
• Conducted reviews as required, of various technology transfer documentation with regulatory and other appropriate groups.
• Assisted with project requirements with outside customers and vendors as directed by firm management.
• Developed knowledge and experience of clean room and aseptic filling operations.
• Was involved in a major investigation in tracing the source of contamination found in the formulation and aseptic fill operations.
• Served as the Waters EMPOWER database administrator for the analytical testing laboratory.