Al Mancini Email & Phone Number

Cranbury, New Jersey, United States

Author of peer-reviewed papers and technical articles pertaining to both the pharmaceutical industry and pharmacy including process and formulation development, manufacturing operations, troubleshooting, technology transfer, packaging, pharmacy operations and medication safety.

Burlington, Massachusetts, United States

- Author and peer-reviewer of articles pertaining to validation and compliance in pharmaceutical formulation, process, analytical and package development including scale-up, manufacturing, quality control/assurance, regulatory and clinical aspects for both the "Journal of GXP Compliance", and the "Journal of Validation Technology".- Member Pharmacy Compounding Committee- Serving as a technical resource for the IVT editorial staff of both journals.

Chicago, Il

- Leading recitation discussions with approximately 300 first and second year pharmacy students on multiple compounding topics including critical thinking skills, calculations, incompatibilities, problem solving and associated discussions both on sterile and non-sterile preparations.- Designing and implementing new advanced sterile and non-sterile prescriptions for student preparations.- Presenting lectures to about 150 second year pharmacy students on medication safety.- Serving as core team member on the cross-functional multidisciplinary research and development of topical dosage form for the treatment of diabetic wounds, funded with a $2.2 million NIH grant.- Successfully prepared and submitted the pre-IND document on diabetic wound care which was well received by the FDA. - Providing direction to pharmacy students in their class elective research support activities.

Chicago, Illinois

- Teaching/counseling about 300 students on various pharmaceutical skills and compounding techniques for standard and advanced preparations including oral liquids, capsules, suspensions, emulsions, creams, lotions, ointments, suppositories, hard and soft troches, veterinary dosage forms and sterile preparations for first and second year pharmacy students.- Designed the formulas and processes for new dosage forms in the research of diabetic wound care.- Performing the formulation and process development of new sterile and non-sterile preparations for the students.- Provided pharmaceutical consultative support in demonstrating the equivalency between gelatin and vegetable grade hard gelatin capsules.- Member of project team in successful design and start-up of a new $2 million start of the art laboratory containing clean rooms and non-sterile compounding areas for the Pharmaceutics program.- Managed the laboratory operations including safety, inventories, repairs, maintenance, cleaning and hazardous waste removal.

Chicago, Illinois

- Served as teaching assistant for the compounding of formulations and advanced formulations by P1 and P2 pharmacy students.- Performed the formulation and process development of 14 new and updated compounded prescriptions for student preparation.- Managed laboratory operations to assure a professional and efficient learning environment by maintaining supplies, proper housekeeping, facility maintenance, and compliance with safety and environmental requirements.- Prepared and conducting presentations to P1 and P2 pharmacy students on selective applied current topics and issues, such as medication safety.- Participatedin the design of a new 44 student capacity formulation/compounding laboratory on a intra and inter cross-functional basis. - Consulted with faculty, staff and graduate students in the formulation and process development of dosage forms for new potential investigational drugs for research projects.

Mount Prospect, Illinois

- Performed technology transfers of oral solid and sterile dosage forms on a global intra- and inter-company basis, comprising a total of > 90 products, involving 7 countries, 10 donating and 9 receiving sites.- Performed technical support to intra- and inter-company manufacturing sites, functions and contractors for oral solid and sterile dosage forms entailing product development, troubleshooting, formula and process optimizations, validations, and internal business process designs/harmonizations on a global basis.Directed group of 9 professionals in the cross-functional development of 63 new products, 16 technology transfers of commercial products, marketed product support for 27 products, 8 ANDA submissions and 4 US product launches in 2013.- Performed technology transfers of oral solid and injectable dosage forms on a global intra- and inter-company basis, comprising > 90 products, involving 7 countries, 10 donating and 9 receiving sites.- Served as the liaison with R&D as the corporate technical operations representative for > 75 new products.

Mount Prospect, Illinois

- Served as the global technical project team member for the provision of marketed product support and to assure launch of new solid and sterile products utlizing the principles of right the first time and statistical concepts.- Served as a core team member for the successful and seamless integration of the techncial services business processes in the Pfizer and Pharmacia merger. Provided for the seamless technology transfer of legacy product knowledge bases without incurred backorder situations. Achieved the company business goals on a seamless and on time basis in a post-merger environment.- Performed troubleshooting support for a syringe and vial steroidal product line.- Supported the technology transfer of 8 different product line transfers between contractors within India, and 1 product line to Puerto Rico.

Mount Prospect, Illinois

- Directed the reformulation and process development, scale-up, technology transfer, validation, production support and project management of branded and multi-sourced, sterile and oral solid pharmaceutical dosage forms for global manufacturing sites.- Served as the technical team member for the process optimization of an ophthalmic blow/fill/seal dosage form, resulting in significantly increased product yields with resultant cost savings averaging >$10 million/year.- Directed the design, validation and packaging of the diluent ampoules for parecoxib injection for more than 80 markets in 4 international manufacturing and packaging sites.- Investigated and implemented corrective actions for the stability and package interaction problems of a protein nasal spray product without incurring stock outages.- Directed the technical support for the successful transfer of 8 tablet product lines to a contract manufacturing site.

Mount Prospect, Illinois

- Directed and managed the marketed product support, line extension development and technology transfer of various dosage forms on a global basis.- Successfully troubleshot the dissolution of an oral contraceptive product under significant contractual delivery constraints without incurring supply disruptions and resultant business penalties.- Underwent two successful FDA preapproval audit inspections of the pilot plant with perfect inspection results.

Mount Prospect, Illinois

- Served as the project technical leader of a 4 person cross-functional core team for the global implementation of project strategies for a complete female healthcare product line entailing relaunches of 35 tablet products from 6 external sites to 4 global company manufacturing sites involving the US and more than 70 international markets and 170 regulatory registration, without incurring any business interruptions and avoidance of a $1 million site closure penalty.- Served as the technical operations member on a 10 person core team for Business Development for the due diligences of several successful asset divestitures and acquisitions totaling over $525 million.- Member of a 3 person core team for the successful product development of Flagyl MR tablets.

Mount Prospect, Illinois

- Planned and managed the formulation, process development and validation of tablet, capsule, oral liquid and injectable dosage forms for IND, NDA and also ANDA products. Performed technology transfers to both internal and external manufacturing sites.- Performed the formulation, primary package, process development, scale-up and technology transfer of lomefloxacin mesylate in ampoules, and premixed ready to use IV piggyback bottles and bags.- Troubleshot the light stability and metal interactions of lomefloxacin mesylate.- Served as a core team member for the business process integration of the technical support operations in the proposed merger between Monsanto and Wyeth Pharmaceuticals.

Mount Prospect, Illinois

- Managed, supervised and performed the product development, realized the approvals and launches of branded product line extensions, new products and multi-sourced products for the company and two global joint venture partners.- Developed eliprodil injection and 2 ANDA tablet products and 1 ANDA capsule dosage form product with successful first to launches for all 3 multi-sourced products.

Mount Prospect, Illinois

- Manufactured specialized blinded oral solid dosage forms for Phase 3 and IV investigational drug trials.- Packaged, labeled, inventoried and distributed the investigational drug supplies for numerous clinical studies against aggressive timelines.

Skokie, Illinois

- Troubleshot separate particulate matter problems with Norpace IV ampoules and Flagyl IV RTU bottles.- Troubleshot discoloration problems with Aminophyllin ampoules.- Served as a preceptor of pharmacy students via the National Pharmacy Council.

Skokie, Illinois

- Designed and developed Flagyl IV RTU - the first premixed ready to use IV piggyback dosage form in the US in glass IV bottles and PVC bags.- Performed process optimization on the lyophilization procedure for Flagyl IV vials resulting in a cycle reduction time from 3 days down to 1 day.- Designed the manufacturing process and lypholization cycle for the injectable enzyme hyaluranidase.- Served as a preceptor of a pharmacy student via the National Pharmacy Council.

Mount Prospect, Illinois

- Designed the IV admixture reconstitution and adminstration procedures for Flagyl IV to successfully reduced the incidence of infusion phlebitis.- Troubleshot an incompatibility between Flagyl IV and its rubber closure.- Successfully resolved Drammamine soft tablets problem in Production.- Served as a preceptor of a pharmacy student via the National Pharmacy Council.

Skokie, Illinois

- Validated the manufacturing processes for radio-labeled 19-iodocholesterol injection, its cosolvent ampoule and the corresponding disposable diluent syringe system.- Performed formulation, process, primary package development, scale-up, technology transfer and validation of new sterile dosage forms for both human and veterinary healthcare.- Prepared investigational drug supplies for Phase 1 through 3 clinical studies.- Provided marketed product technical support for sterile and oral solid dosage forms on an intra- and inter-company sites on a global basis.

Bachelor Of Science, Pharmacy

Activities and Societies: Student American Pharmacists Association (SAPhA) Student Council Vice-PresidentMinor in Industrial Pharmacy

Pre-Pharmacy Program