Project Manager Jobs

Job Title: Quality Control Project Manager Company: Tolerx, Inc. Location: Cambridge, MA Description: Quality Control Project Manager We are seeking a talented, highly motivated Quality Control professional to coordinate assay development, qualification, and validation, as well as to execute drug development plans/teams. The person in this position will also assist with development, qualification, and validation of bioanalytical assays for release of bulk and final product (therapeutic antibodies) for use in pre-clinical studies and clinical trials. Responsibilities for this position include: In conjunction with multi-functional internal and external Team Leader(s) will be responsible for planning and executing QC strategy for all phases of drug development. Interact extensively with R & D, CMC, and Regulatory departments as well as external partners and contract testing laboratories. Responsible for QC project performance, risk assessment/management, and issue resolution of cross functional teams. Manage projects independently with little supervision to create and drive timelines to keep projects on schedule. Manage contract labs to ensure scheduled testing is completed according to timelines. Management and risk evaluation of scientific and/or manufacturing activities for internal clinical development projects, contract manufacturing, and contract laboratories at various stages of clinical development. Present project status to upper management. Manage competing timelines and prioritize tasks in coordination with corporate objectives. Effectively facilitate the resolution of complex scientific, technical, analytical, and business issues with external clients/partners Qualifications of the ideal candidate: Minimum 5 years of relevant work experience in project management within the Biotechnology field. 7-10 years of experience in a GMP Quality Control laboratory. B.S. or M.S. in life sciences or other biologics-related discipline required. Skilled in use of and reporting from project management systems like MS Project. Thorough understanding of drug development process from a Quality Control perspective with pre-clinical and clinical trial execution experience. Extensive familiarity with current regulations (FDA, EU, ICH, etc.). Strong and effective organizational, communication, presentation, and writing skills. Strong interpersonal skills; must be capable of effectively establishing professional rapport with internal personnel, various levels of management, and external partners. Strong influencing skills, ability to get tasks done without having formal authority. Project Management Certification highly desirable. Job Code: QCPM 6/2008