Experience

Trinzo

• Ireland
• Business Consulting and Services
• 1 - 100 Employee

• Senior Project Manager

  • Mar 2020 - Present



JPL Pharm-Med Consulting LLC

• Ridgewood, NJ

• Owner (Consultant)

  • Mar 2018 - Present

  • Provide scientific and technical advice and assistance to businesses primarily focused on pharmaceutical products or medical devices. • Maintain expertise in formulation, product and device development, process development, technology transfer, and quality systems and compliance. • Provide various levels of consulting in Product Development of pharmaceutical products in various stages of development from pre-clinical to NDA/ANDA filings. • Emphasis on the management of full-scope development programs that require thorough understanding of the regulatory requirements, FDA’s current expectations and management of programs at multiple CMOs. • Focus on formulation development, and process scale-up and manufacturing of oral thin films, transdermal drug delivery systems, topical patches, and parenteral dosage forms.



Trinzo

• Ireland
• Business Consulting and Services
• 1 - 100 Employee

• Senior Project Manager (Consultant)

  • Mar 2019 - Jan 2020

  • EU MDR project for global medical device company to update existing processes to include new regulations. • Guide teams through the planning process and assist in the creation of program documentation including: development of Project Charters, Work Breakdown Structures, Project Plans, and Periodic Reports. • EU MDR project for global medical device company to update existing processes to include new regulations. • Guide teams through the planning process and assist in the creation of program documentation including: development of Project Charters, Work Breakdown Structures, Project Plans, and Periodic Reports.



Par Pharmaceutical

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Director, Transdermal Operations

  • Jan 2015 - Feb 2018

  • Oversee complete production process for transdermal and thin-film pharmaceutical products produced in Par’s Stratford CT facility from dispensing raw materials to packaged finished goods. • Maintain the master production schedule to effectively manage manpower, materials, and production capacity based on demand. • Assess equipment and labor capacity to achieve anticipated production requirements. • Guide the design and scale-up of processes, control systems, and equipment from the laboratory through pilot plant and manufacturing at commercial scale. • Oversee implementation and execution of all process validation programs. • Interact with FDA and other regulatory bodies as necessary to explain and defend Par practices for process development and validation. • Responsible for the daily safety and training compliance for site production, technical operations, and engineering departments. • Ensure compliance with OSHA regulatory requirements including: environmental, safety, health, industrial hygiene, and related areas. • Instrumental in the update of site processes and procedures to conform to ISO 13485:2016 and 9001:2015 standards.



Innoteq Inc.

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Dircetor of Operations / Technical Director

  • Nov 2008 - Jan 2015

  • Lead pharmaceutical product development, technology transfer, and product manufacture according to FDA guidelines, GMP and ISO 13485:2003/9001:2008 requirements for clinical trials of IND, and NDA or ANDA.• Provide oversight and direction for individuals and teams responsible for creating and executing formulation development, early process development/scale-up/transfer, supporting GMP supply plans, and developing/documenting the knowledge base needed for regulatory filings.• Provide Project Management for new product development, process development, and technology transfer of pharmaceuticals, medical devices, and dietary supplements.• Identify personnel needs, training, and develop subordinates in product development, plant operations, facility maintenance, process, and equipment validations.• Provide input to the development of program strategy, budgets, timelines, and formulation development plans to ensure that technical and business requirements are managed and met.

• Technical Director / Quality Director

  • Nov 2008 - Apr 2012

  • Lead Product Development, Analytical Development, Technology Transfer, and Quality groups for Contract Manufacturing Organization according to FDA guidelines, GMP, and Global Standards for products including: Pharmaceuticals, Medical Devices, Dietary Supplements, and Cosmetics.• Oversee Creation and Implementation of Pharmaceutical cGMP Quality systems to ensure all products manufactured at the site are produced, tested, and released in compliance with SOPs, cGMPs, and FDA regulations. • Ensure systems, resources, reviewed actions, and made decisions to attain sustainable compliance.• Serve as primary contact for all site audits conducted by regulatory agencies and customer.



Lohmann Therapy Systems

• West Caldwell, NJ

• Formulation Scientist

  • Aug 2005 - Oct 2008

  • Support formulation manager with product developmental work including: writing protocols, executing studies and writing reports. • Worked with Manufacturing, Technology Transfer, and Quality Control groups in the scale-up process of products to production. • Perform analysis on experimental samples using the Haake Rheowin 600 viscometer, Netzch DSC 204, and the Netzch DMA 242. • Trained new Formulation personnel on laboratory techniques. • Encompass technical responsibilities associated with the Specialty Laminate and Medical Tape coating including new product design, raw material changes, quality testing, and documentation.



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Research Associate

  • Sep 2003 - Aug 2005

  • Support senior scientist in formulations development with product development work including: writing protocols, executing studies, and writing reports. • Hands-on experience with equipment for developing parenteral products including: liquid filling machines, autoclave ovens, depyrogenation ovens, vial washers and laminar flow hoods, and for analyzing samples such as Liquid Particle Counters, pH meters, DO meters, densiometers, and osmometers. • Maintained controlled documents, training folders, and laboratory data for R&D operations at site (analytical, chemical development, formulations, reference standards and stability). • Conduct internal site audits and participate in support of pre-approval inspections by the FDA.



Complete Analysis Laboratories, Inc.

• Parsippany, NJ

• Analytical Chemist

  • Jul 2002 - Sep 2003

  • Complete routine analysis in an FDA registered laboratory according to GLP and cGMP utilizing in-house developed methods, compendial methods (USP/NF, EP, and JP), and Global Standard ASTM. • Perform routine analysis on environmental samples including: BOD, TDS, TOC. • Analyze raw materials and finished products including: Assay, Degradant analysis, Impurity analysis using HPLC, GC and FTIR. • Complete routine analysis in an FDA registered laboratory according to GLP and cGMP utilizing in-house developed methods, compendial methods (USP/NF, EP, and JP), and Global Standard ASTM. • Perform routine analysis on environmental samples including: BOD, TDS, TOC. • Analyze raw materials and finished products including: Assay, Degradant analysis, Impurity analysis using HPLC, GC and FTIR.