職位描述
職位描述：
Job Responsibilities：
? Supervise the JHL Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).
? Provide support within the Quality Control department for the testing and evaluation of environmental monitoring, product, in-process, and raw material samples.
? Lead, coach and develop the Quality Control Laboratory team, review colleagues’ performance, set and communicate objectives, priorities, metrics, development plans and conduct performance assessments.
? Lead and manage the laboratory testing for Analytical Chemistry, Biochemistry, Viral & Safety, Technical Services, and Senior Technical staff.
? Align with corporate Quality processes and IT systems such as product testing, CAPA, lab investigations, stability testing, LIMS, lab equipment calibration providing support to QC Systems.
? Take a lead role in providing guidance and support on failure investigations and resolution of OOS investigations ensuring staff development in this area.
? Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness
? Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews
? Manage performance and development of direct reports providing regularly scheduled feedback throughout the year to ensure achievement of organizational and department goals and a productive environment.
? Proactively use scientific literature and guidelines to solve problems.
? Ensure test methods are qualified/validated to support production of products for clinical or commercial use.
? Identify and interact with outside manufacturers and contract test labs.
? Provide complete data analysis and be able to drive projects to completion using data generated in the design of new experiments and/or critical assessment.
? May contribute to sections of regulatory submissions (primarily IND, BLA etc.).
? Ability to recognize, trouble-shoot, and resolve problems with equipment or individual assays.
Job Requirements:
? Bachelor’s degree with 9+ years’ experience in Biotechnology industry in which 6+ years in quality managerial position, Master’s degree with 6+ years’ experience. Or PhD with 4+ years’ experience in biotechnology induction in which 4+ years’ in quality managerial position.
? Thorough knowledge of GMP regulations and documentation.
? Ability to train others in the application of GMP. Ability to manage multi-disciplinary teams.
? Ability to make contributions across departments, and to effectively interact across departments in pursuit of company goals.
? Excellent verbal and written communication skills; able to communicate in English
? Working knowledge of GMP as it relates to Biologics.
? Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval
