Nick Cardoso Email & Phone Number

Boston, MA, US

Boston, Massachusetts, United States

Cambridge, Massachusetts, United States

• Managed all drug product development and clinical/commercial manufacturing at CMOs for all the products, including pediatrics and line extension
• Wrote/Reviewed Technical Reports, Batch Records, SOPs, Deviations, Change Controls, Design of Experiments, Formulation Protocols and INDs
• Designed and executed experimental programs to develop phase I, II, and III clinical and commercial formulations
• Authored the drug development and manufacturing sections of an IND for a new entity with a successful FDA approval
• Authored and updated all drug product sections for all regulatory filings across all projects
• Lead a CMC working teams for commercial and developmental products

Cambridge, Massachusetts, United States

Burlington, Massachusetts

• Lead the scale-up and technology transfer of a specialized manufacturing process for a parenteral formulation (a combination product containing a powder, diluent and medical device) to contract manufacturing sites
• Managed the clinical manufacturing at CMOs and all the associated analysis including cleaning
• Assisted in a successful MHRA and FDA audit of commercial manufacturing sites
• Managed the expansion of a commercial site (doubling capabilities) which includes cleaning validation, equipment purchasing, qualification and validation
• Wrote/Reviewed Technical Reports, Batch Records, SOPs, Deviations, Change Controls, Design of Experiments, and Formulation Protocols
• Designed and executed experimental programs to develop phase I, II, and III clinical and commercial formulations

• Lead the design and assisted in the coordination of building a clinical manufacturing annex; with capabilities of Phase I through commercial in a newly acquired location.
• Assisted in the installation, qualification and registration of a fully continuous manufacturing line which consists of blending, wet granulation/dry granulation, compression, and coating line.
• Lead external and internal audits of the clinical manufacturing annex
• Formulated and developed novel oral solid dosage forms including tablets, capsules, suspensions, and parenteral formulations.
• Managed the internal clinical/commercial manufacturing of multiple projects simultaneously
• Oversaw the scale-up and technology transfer to contract manufacturing and clinical sites

Cambridge Mass