Job Description
This is an 11-month contract. This role is based fully onsite Purpose Responsible for the effectiveness of the Cell Culture laboratory focused on carrying out cell culture techniques, culture handling-maintenance and culturing of cell lines and carrying out cell-based bioassays. Act as a cell culture SME and supporting troubleshooting activities. This is a day role, Mon-Friday based on site. Responsibilities Work as directed by the Quality Control Manager / Associate Director, according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Perform routine cell culture maintenance Responsible for planning and overseeing cell culture activities Develop, implement and maintain procedures that comply with appropriate regulatory requirements. Ensure that all Quality Systems within the department are adhered to on a daily basis. Operate as part of the QC team performing the allocated testing and laboratory based duties. Participate in laboratory management (equipment, stocks, cleaning) Ensure timely completion of all assigned data processing and reviewing. Ensure timely completion of Laboratory Investigation Reports and deviations through site procedure Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc. Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved. Where applicable, review, approve and trend test results. Participate in the laboratory aspects of OOS investigations Ability to lead/mentor team of lab analysts Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc, Provide support with audit/inspection requirements to ensure department compliance/readiness Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned Requirements Minimum Education: Bachelors Degree or higher preferred; ideally in a science related discipline. Typical Minimum Experience: 2 years prior related work in handling cell culture and cell culture methodologies preferably in a GMP Setting Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices. Knowledge of cGMP Cell culture techniques, media preparation, cell thaw and cell based bioassays microscopy Laboratory Quality Systems Proficiency in Microsoft Office and job-related computer applications required Report, standards, policy writing skills required Understanding of Lean Six Sigma Methodology preferred. 4.2 Business: Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Planning and scheduling skills Flexible approach Proven organizational skills Effective time management and multi-tasking skills Excellent attention to detail Trouble shooting skills Experience in handling adherent and suspension cell lines Skills: Cell Culture GMP Cell Culture Bioassays Quality Systems