Associate Director, Process Development

Company OverviewImClone Systems is dedicated to developing and commercializing novel therapeutic products in the field of oncology. Our efforts have resulted in a broad spectrum of innovative product candidates with potential application in multiple tumor types. As a member of the oncology community, we are committed to providing treatments to meet the unmet needs of cancer patients. To fulfill this commitment, ImClone Systems fosters integration of the principles of teamwork and scientific integrity into all facets of the Company's activities. We believe that these values will benefit patients, physicians, and our employees while creating value for our shareholders. HistoryThe Company was founded in 1984 and in 1986, opened its laboratories at 180 Varick Street in New York City. In its early years, the Company focused on immunology-based diagnostics and infectious disease vaccines. This focus resulted in two FDA approved diagnostics and several vaccine research programs, all of which have been licensed to pharmaceutical companies. During the early nineties, the Company's focus shifted from diagnostics and infectious disease to the development of a pipeline of innovative, biologic compounds in the area of oncology. From this pipeline, three investigational monoclonal antibodies are being evaluated in various stages of clinical development. OperationsImClone Systems operates in two locations - its corporate and scientific headquarters at 180 Varick Street in New York City, which houses the Company's research and executive offices, and its campus in Branchburg, New Jersey. The Branchburg facility is home to the manufacturing, product development, finance, clinical, regulatory and quality assurance and commercial operations departments. This position will manage a small group of individuals responsible for the systematic design, execution, analysis and reporting of small-scale process validation studies to support cell culture process development and manufacturing operations. This includes determination of critical operating parameters and process range evaluations using erlenmeyer flasks and bench scale bioreactors as well as various raw material expiration studies applicable to production of commercial or clinical stage biological products. The position will require good communication and problem solving skills in order to effectively work with colleagues from multifunctional areas in a team-oriented environment. 1. Effectively manage all group activities and develop scientific staff to build a reliable and responsive team- oriented group2. Set group objectives, observe and evaluate performance of employees3. Monitor workload and re-prioritize as necessary to maintain project timelines4. Participate in the budgeting process, monitor and control spending to budget5. Design strategic studies to identify and determine interaction of critical operating parameters6. Manage or conduct process range evaluation studies using erlenmeyer flasks and bench scale bioreactors to support cell culture process validation7. Analyze data, interpret results and draw conclusions from experiments and studies.8. Manage completion or independently write necessary documentation including SOP's, protocols, reports and regulatory submissions9. Collaborate and communicate with other departments to ensure appropriate transfer of information to enable efficient and regulatory compliant manufacturing processes 1. B.S./M.S. degree with a minimum of 8-10 years relevant experience is required2. Prior supervisory experience is required3. In depth knowledge and prior experience with aseptic cell culture techniques, small-scale cell culture process development and hands-on bioreactor operations including scale-down model systems is required4. Prior experience with process validation, range evaluation studies is necessary5. A good working knowledge or prior use of statistical design of experiments (DOE) is desired6. Knowledge of cGMP's and regulatory requirements for biologics is also desired RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2239282&boardid=749