ChromaVision Medical Systems, Inc., located in San Juan Capistrano, CA, is a provider of cellular imaging diagnostics and manufacturer of the Automated Cellular Imaging System (ACIS(tm)). We are currently seeking experienced professionals for the following positions: Research Associate, Assay Development We are currently seeking a qualified professional for the position of Research Associate, Assay Development. The successful candidate will perform experiments to develop cell-based assays in conjunction with the ACIS application(s) development. This position requires a BS/MS in a biological science with at least 2 years' of clinical or industry experience in assay development or a medical technology degree. Technical expertise with immunohistochemistry, histopathology, assay development, and cell or tissue analysis techniques is required. Prior cell based diagnostic experience in a commercial, clinical, or reference laboratory setting is desired. Experience with in-situ hybridization a plus. Must have good computer and documentation skills and have the ability to work independently within a team environment. Field Applications Specialist We are currently seeking three qualified individuals for the position(s) of Field Applications Specialist. The three regions available are the Northeastern, Southwestern, and Southeastern regions of the US. The successful candidate(s) will train customers on ACIS and applications, provide sales support, and manage Beta sites. Requires an undergraduate degree in Biology or Medical Technology, plus a minimum 5 years' technical experience with laboratory diagnostic products. Ability to develop technical or product training courses is essential. IHC, (F)ISH, and cytochemistry methods and sample preparation a plus. Background in diagnostic assays related to cancer or infectious disease and working knowledge of imaging technology or flow cytometry preferred. Must possess excellent presentation/communication skills, as well as proficiency in Windows 95/98/NT, Word, Excel, PowerPoint, Access, or similar database. Up to 75% travel required. Sr. Software Analyst This highly visible position will be the lead of a newly formed group that is responsible for maintenance and enhancement of the current release of the ACIS software. The successful candidate must have a BS/MS in computer science or other engineering discipline and at least 10 years' programming experience. A combination of experience and education may be considered. Experience with MS Visual C++ development environment and Windows NT a plus. Must be knowledgeable in current industry trends and developments. The Sr. Software Analyst will respond to deficiency reports from customer service, sales, and marketing. This requires analysis of the problem, determining the root cause, gauging the extent and impact of the change, and executing it. Manager of Clinical Trials This very high-profile individual will manage and oversee all phases of clinical trials for new products. This will include evaluating product safety and efficacy; ensuring accuracy and quality of clinical data for market approval applications; developing/ ensuring compliance with clinical protocols and processes; and, providing input to engineers in the device development process. The incumbent will also write Clinical Study Reports in support of 510(k) and PMA applications to the FDA, as well as supervise lab technicians and clinical research staff in-house and at contract research organizations. The position requires a minimum of a BS degree in Life Sciences, or related field, and 4+ years' experience monitoring clinical trials for medical devices. Also essential, 7+ years' medical device industry experience, proven training experience, and familiarity with GCP and GLP. CRA certification preferred. Candidate must be a goal-oriented self-starter who is capable of highly accurate work within a demanding, deadline-driven environment. Good analytical and problem-solving skills are a must, as well as excellent math skills and a solid working understanding of standard statistical methods/procedures. The ability to work effectively in a matrix/team setting is critical. Must be fluent in English and possess excellent written/verbal communications, good interpersonal skills, and the ability to oversee several critical projects simultaneously while meeting deadlines and budgets. Must be willing to travel 30%-50%. Manager of Reagent Development This key position is responsible for the transfer of assays from R&D to full commercial production. This includes working with internal staff and outside vendors to define product specifications, conduct validation studies, analyze data, and write technical reports. Requires excellent understanding of how to take small R&D assays and scale them up for large production runs. The incumbent must be skilled in developing commercial IVD kits, as well as managing the procurement and selection of all packaging materials. Will also manage technical support for kits and reagents. Position requires a Ph.D., or MS degree, or equivalent experience in immuno-histochemistry, plus 10+ years' industry experience. Must have direct experience with commercializing new lines of reagents and associated kits. Proven troubleshooting and analytical skills, along with the ability to work well in a matrix team environment required. Candidate must also be fluent in English and possess excellent written and oral communication skills with good attention to detail. Solid working knowledge of GMP/GLP requirements and a basic understanding of statistics are essential. Must have the ability to analyze data and prepare technical reports, as well as manage multiple tasks and meet aggressive deadlines. Strong project management, problem solving skills, and a proven ability to influence others important. Must possess excellent math skills and a good working understanding of statistics. ChromaVision offers a highly competitive compensation and benefits package including 401(k) and incentive stock options. We enjoy a team-based approach to success in a business-casual work environment. For consideration, send resume indicating position of interest and salary requirements to: ChromaVision Medical Systems, Inc., 33171 Paseo Cerveza, San Juan Capistrano, CA 92675; Fax: (949) 443-3372; E-mail: EmpApp@chromavision.com EOE © 1998 ChromaVision. Questions or comments: info@chromavision.com <mailto:info@chromavision.com>
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