Vacancy has expired
Show me jobs like this one| Job Ref: | 39PM |
| Job Type: | Full Time |
| State: | California (CA) |
| City: | San Diego |
| Post Code: | Jan 25, 2012 |
| Job Description: |
Fate Therapeutics is an innovative biotechnology company developing novel stem cell modulators (SCMs), biologic or small molecule compounds that guide cell fate, to treat patients with very few therapeutic options. Fate Therapeutics lead clinical candidate, ProHema, consists of pharmacologically-enhanced hematopoietic stem cells (HSCs) designed to improve HSC support during the normal course of a stem cell transplant for the treatment of patients with hematologic malignancies. The Company is also advancing a robust pipeline of human recombinant proteins, each with novel mechanisms of action, for skeletal muscle, beta-islet cell, and post-ischemic tissue regeneration. Fate Therapeutics also applies its award-winning, proprietary, induced pluripotent stem cell (iPSC) technology to offer a highly efficient platform to recapitulate human physiology for commercial scale drug discovery and therapeutic use. Fate Therapeutics is headquartered in San Diego, CA, with a subsidiary in Ottawa, Canada. Fate Therapeutics development group is seeking a motivated and talented individual to serve as a Technical Specialist for Fates clinical stage ex vivo cell therapy program. The successful candidate will demonstrate technical expertise in development and manufacturing of cell therapy products, producing tangible and timely results as products progress from early development towards registration and subsequent commercialization. The ideal candidate will have expertise in development and clinical manufacturing of cell therapy products in a GTP/GMP environment. Candidates must thrive in a fast-paced team environment. Excellent communication, organizational abilities, and problem-solving skills are a must. Responsibilities The ideal candidate will be responsible for a range of activities focused on establishing, managing, and conducting studies in a pre-GMP lab for development and qualification of manufacturing processes, materials, devices, and assays. Activities will include: Develop and optimize manufacturing processes Develop and optimize assays for product characterization, in process testing, and release testing, such as cell counting and flow cytometry Manage receipt, storage, and tracking of product samples and cryopreserved cell products. Develop and optimize novel functional assays, in collaboration with research team Design, conduct, and interpret studies to qualify new materials, devices, methods, assays, and processes used in cGMP manufacturing Facilitate the transfer of manufacturing and assays to clinical sites Write, review, and approve SOPs, technical reports, validation reports, and regulatory documents Establish and maintain productive working relationships with internal organizations such as Research, Quality, and Regulatory Conduct internal activities such as seminars and presentations, budgeting, and project planning Establish and maintain productive relationships with external organizations such as academic institutions, contract developers and manufacturers, regulatory authorities, and professional organizations Ensure that industry standards and best practices are effectively applied Participate in and lead technical meetings for sharing and applying scientific knowledge Manage in-house lab quality program Requirements B.S. or advanced degree in biology or medical technology |
| Post Date: | 01/26/2012 |
