Mark Moreno
Principal Consultant, CAI
Mr. Moreno has over 34 years of Pharmaceutical Manufacturing experience in aseptic processing, technical service and drug product development; most of which was at Eli Lilly and Company. He developed several drug product dosage forms including oral solutions, Blow-Fill-Seal sterile inhalations and parenteral liquid and freeze-dried presentations: Responsible for devising and performing lab studies to determine the formulation and process leading to clinical supply and final commercialization phases, and supporting process/product boundary parameters. 10 years as a technical service representative for parenterals (small and large molecule dosage forms) with considerable engagement with operations, quality and engineering for continuous improvement and CAPA remediation.
Mark is experienced in technical transfer exercises including scale-up activity, master batch record, validation and control
strategy design and reports. During his career as a pharmaceutical scientist, he gained considerable knowledge with the
formulation of freeze-dried formulations and freeze drying cycle development, including freeze drying microscopy. Experienced in manual visual inspection equipment, inspector qualification and methods for current regulatory expectations.
