Vice President, Biologics Manufacturing

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 is responsible for directing the manufacturing of company products from clinical through commercial manufacturing in compliance with cGMP. This position will interact regularly with other senior managers of Process Development, Engineering, Logistics and Quality. The position is responsible for achieving company objectives through several middle managers who manage the product inventory, logistics, cost of goods, technology transfer, plant design and start-up, and manufacturing schedule. This position will make final decisions on operational issues for the various organizations that are managed. Decisions affect the success of the company and erroneous decisions will result in failure to achieve critical objectives.1. Develop hiring plans to staff critical areas in manufacturing and to establish the infrastructure in alignment with corporate objectives.2. Start-up and operate manufacturing plants, ensure operations are under cGMP, and balance production capacity, product mix and staff assignments to meet both short term and long term demand requirements.3. Work closely with engineering and outside firms to design and build manufacturing infrastructure to meet future demand projections.4. Develop SOPs and policies to operate the manufacturing plants.5. Serve as principal spokesperson for the manufacturing group.6. Make recommendations to other Senior Managers regarding corporate objectives and policies.7. Work closely with other organizations to ensure quality products are manufactured.8. Interact with Senior Management of strategic alliance partners to ensure goals of all organizations are met.9. Introduce process innovations to increase manufacturing efficiencies, maintain product quality, and improve COGS of company products. 10. Develop a responsible budget that is in alignment with corporate objectives. 1. BS degree minimum with 15+ years experience. Advanced degree in Biochemical Engineering or related discipline preferred.2. Thorough knowledge of cGMP compliance requirements related to the manufacture, testing and release of products for clinical and commercial supply to the US and international markets. Must have regulatory knowledge and direct experience dealing with regulatory agencies3. Experience operating a plant making a biotechnology product required. Experience in large-scale cell culture and protein purification required.4. Practices sound engineering principles.5. Experience in design, equipment selection and start-up of manufacturing plants.6. Effective planner to maximize production capacity and utilization of assets.7. Maintain knowledge of current and latest developments in manufacturing of biologics and other areas related to the product and the pipeline; ability to implement process improvement programs such as QBD, Six Sigma, etc.8. Proven history of forming effective working partnerships with colleagues, subordinates, external counterparts, direct and dotted-line reports.9. Excellent interpersonal and technical communication skills with the ability to interact with all levels of the organization.10. Exhibit strong leadership qualities. Demonstrated effective skills in team building, credibility and conflict resolution. Able to interact with all levels of the organization and give dynamic and compelling presentations.11. Excellent organizational skills, the ability to work on concurrent projects of varying complexity and utilize sound project management skills including setting goals and milestones and managing activities across functional groups to meet aggressive targets. 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=2195323&boardid=749