Timothy Fitzpatrick Email & Phone Number

Bothell, Washington, United States

Kirkland, WA

I am currently consulting for the pharmaceutical industry in the CMC space focusing on small molecule API development and manufacturing (internal or through CMOs) as well as technology transfer, process optimization, scale-up, due diligence, sourcing, quality systems and all aspects relating to the CMC pipeline. I have previous expertise managing CMO and.

Seattle, WA

Community member of the UW's Institutional Review Board. Review human subject clinical trials application that take place at the University or under their purview.

Seattle, WA

Directed all aspects of CMC to support all phases of clinical trials, including API manufacturing and Drug Product manufacturing, clinical supply, collaborations with partners, regulatory CMC filings, stability programs, etc.

Redmond, WA

Led establishment and all operations for 20 person CMO facility focused on preclinical and early clinical API development, including GMP manufacturing to phase 2. Led all business at site, including business development, project evaluation, proposal writing, contract negotiations, and pricing. Represented site at conferences and customer visits..

Led ICOS’s Building 8 facility and the Small Molecule Manufacturing group, which was responsible for all internal and external small molecule API manufacturing and CMC project management.

Worked with numerous CMO and emerging pharmas to place GMP projects and raw materials.

Responsible for the Process Development, Research Laboratories and Pilot Plant Facilities (17 personnel and ~4000 gallons of reactor space). Represented the company at scientific conferences and lead the customer contact on technology exchange and scientific discussions. Management responsibilities include all operational costing and scheduling, training.

Carried out synthesis and investigation into SAR of Bradykinin antagonists. Responsible for SPPS (solid phase peptide synthesis) facility and equipment sourcing and testing.

Associate Responsible for the SPPS facility and initiation and development of a series of probes utilizing synthetic hemoglobin (RhB1.1) as a delivery device.

Synthesized over 330 analogs of LHRH 10 residues (full length) to 3 residues for the purpose of drug discovery and development (mg to multi-gram scale). Synthesized novel amino acids and peptide mimics for peptide incorporation. Initiated probes into SAR and the resulting biological effects. Assisted in IND technical and experimental sections, patent, and.

Ms, Organic Chemistry

Bachelor'S Degree, Chemistry