Senior Manager, Commercial Quality Control Drug Product Testing
Intarcia Therapeutics, Inc., incorporated in June 1995, is a biopharmaceutical company with an approach to acquire, develop and commercialize therapeutic products for the treatment of cancer and infectious diseases. The Company is developing atamestane, its aromatase inhibitor, in combination with toremifene, an approved estrogen receptor blocker, for the treatment of hormone-dependent breast cancer in postmenopausal women. During the year ended December 31, 2004, Intarcia Therapeutics, Inc. was in Phase III clinical development with this combination for the initial or first line treatment of hormone-dependent advanced (metastatic or locally advanced) breast cancer in postmenopausal women. It is developing omega DUROS, a subcutaneous implant designed to deliver its omega interferon, for the treatment of hepatitis C. The Company has completed a Phase II clinical trial of omega interferon.
Quality professional with 10 years of experience in the medical device and pharmaceutical industries. Johnson & Johnson certified Process Excellence Green Belt. Strong statistical, scientific, and Quality background. Passionate about the impact, need, and benefits of the Quality field. Possess a variety of laboratory skills and instrumentation knowledge, such as FT-IR, GC, HPLC, and dissolution/elution apparatus. Compliant in cGMP, FDA/CDER, ICH, and ISO requirements. Described as a detailed and multitask-oriented, dependable, hard-working, self-motivated, fast-learning, and team player that has excellent oral and written communication skills. Specialties: Analytical Chemistry, Quality Assurance, Statistical Analysis, Method Transfer/Validation/Verification