Donovan Farris Email & Phone Number

Watertown, Massachusetts, Us

Seattle, Washington, Us

I manage operations, regulatory compliance and quality control for a gene and cell therapy laboratory that supports allogeneic and autologous cell therapy manufacturing under cGMP guidelines for clinical trials. The facility has four separate ISO-7 suites and is located on the Clinical Research Center unit within the University of Washington Medical Center (UWMC). I direct and oversee the production of modified cellular products for patients participating in clinical protocols at UWMC, Fred Hutchinson Cancer Research Center (FHCRC) and other partners.The Gene and Cell Therapy Lab provides the infrastructure, training and technical expertise necessary to develop and manufacture autologous and allogeneic gene-modified cells, vector production and ex-vivo manipulation of cells for novel gene and cell therapy products. Ensuring adherence to stringent FDA, IRB and institutional regulations.

Seal Beach , Ca, Us

- Technical Manufacturing Expert- Part of a cross functional team that identified, audited, and selected a CMO for the purpose of manufacturing immunotherapies within Europe for clinical and commerical patients- Managed Technical Transfer team to a contract manufacturing facility in the European Union (Netherlands), which successfully transferred the process for clinical and commercial launches. Tech transfer included tasks such as installing/validating equipment, generating/reviewing protocols, generating/implementing training plans, ensuring the facility met all EMA guidelines for sterile manufacturing, and process validation.- Reviewed and input on EMA filings for clinical and commercial production- Managed change controls to ensure EU manufacturing practices stayed compliant with company wide changes- Front line support for manufacturing issues during clinical and commercial production- Worked with cross functional team to develop an automated process to replace the manual production, reducing COGs and headcount needed- Trained initial GMP manufacturing associated on the automated process, in preparation for process validation and launch of the new process

Seal Beach , Ca, Us

- Managed a team of up to 10 manufacturing associates and supervisors working evening/night shifts- Managed all clinical production activities that lead to the completion of phase 3 clinical trials. Data used from these trials lead to the approval of the first FDA approved immunotherapy product.- Assisted in facility plans and layout for the first commercial production facility (IMF) in New Jersey- Assisted in hiring and training the initial production staff for the New Jersey IMF- Served as subject matter expert for 2010 FDA pre-licensing inspection for the production facility in New Jersey- Assisted in initiating new Phase I/II clinical trials for breast and bladder cancers

Seal Beach , Ca, Us

- Managed a team of up to 8 manufacturing associates working evening/night shifts- Produced clinical immunotheropy products to support phase 3 data for filing for eventual drug approval in 2010- Managed change controls, CAPAs, and non-conformaces for all clinical production processes- Authored, revised and reviewed GMP production documents, such as SOPs, protocols, batch records and forms- Production expert in cross-functional team that developed, validated and implemented an electronic ERP system used to track materials, patient chain-of-identity, and process information

Seal Beach , Ca, Us

- Technical Expert- Wrote and designed manufacturing SOP's and Batch Records- Worked in cross functional teams to establish manufacturing practices that would be used in the commercial manufacturing of the product- Work in cross functional teams to build a proto-type cleanroom used in the commercial model- Optimized manufacturing processes to reduce time and materials while increasing compliance

Seal Beach , Ca, Us

- Produced clinical immunotherapeutics for Phase 3 trials used for the approval of the first prostate cancer immunotherapy.- Produced treatments using aseptic techniques in a ISO 5 and ISO 7 cleanroom environment

- Produced sterile solutions, buffers and medical devices in a ISO 5/ ISO 7 cleanroom.- Wrote and developed manufacturing SOP's and Batch Records

Redmond, Washington, Us

-Worked in call center for troubleshooting and technical support- Worked in QA ensuring third party products met Nintendo quality standards