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 internal manufacturing resources as well as chemical development activities at various companies. I have an excellent knowledge of the chemical industry and have been on many different sides of the industry, including small and large pharmas, CMO's, and fine chemicals.

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. Responsible for all activities to meet worldwide compliance goals of Lanxess Corp.

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, project management, directing research and development, and implementing new technology. ). Directed chemical operations for the entire facility (pilot plant plus four 2000-gallon reactors in manufacturing). Headed pilot plant and laboratory expansion and redesign.

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 publication preparation and submission.

Ms, Organic Chemistry

Bachelor'S Degree, Chemistry