• 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

• 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 • Assisted with the submission of an SNDA with successful approval

• 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• Managed the internal clinical/commercial manufacturing of multiple projects simultaneously• Qualified and validated, for clinical/commercial use, equipment and processes • Assisted in developing in-house clinical manufacturing capabilities.• Managed all in-house solid oral dosage clinical manufacturing including; batch record generation, inventory and equipment control, and project planning• Wrote/Reviewed Technical Reports, Batch Records, SOP's, Qualification reports/protocols, Validation reports/protocols, Design of Experiments, and Formulation Protocols.• Assist with the submission of multiple IND’s and 3 NDAs.• Designed and executed experimental programs to develop phase I, II, and III clinical and commercial formulations • Present periodic internal seminars on in-hand projects and technical topics.• Trained new employees on formulation processes/equipment and laboratory protocols.