Technical Manager

CPL

Shannon

Technical Manager. To build and lead a team of tech transfer and process specialists supporting our clients own Plasmid and Viral Vector manufacturing capability in Shannon - Ireland. To provide technical on-site support and lead setup, scale-up and implementation of Plasmids and Viral Vector manufacturing processes at the Shannon manufacturing facilities. To support the organisation and processes in product lifecycle management activities including validation of manufacturing processes and methods in line with ICHQ8-10 guidelines. Major Activities. Primary Liaison between Manufacturing Operation and Process Development functions to ensure smooth, accurate and timely transfer of knowledge in line with clinical/commercial supply requirements. Project Leadership/Management, scheduling and formal reporting of tech transfer and validation for each new product to establish manufacturing readiness for PPQ, Launch and subsequent lifecycle management. Responsible for Product Lifecycle Management activities including Process Validation of processes in line with ICHQ8-10. Lead and/or provide technical support using established problem solving techniques for investigations into Quality Events. Provide technical recommendations, co-ordinate and execute CAPAs. Management of Change Controls; Providing impact assessments as a Technical Functional, coordinating input and support from development if required. Lead / Support and/or coordinate the action plans. Responsible for development, review, approval of production operation documentation (i.e. master Batch Manufacturing Records, Standard Operating Procedures, Qualification protocols. Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures. Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken. Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state. Main Team Activities. Provision of technical expertise for Plasmid and AAV manufacture. Co-ordinate and participate in cross functional teams to complete root cause analysis using established problem-solving techniques. Reporting and presenting findings, outcomes and recommendations. Manage and/or support any transfers from development, CMOs and partners into and between the manufacturing facilities. Leading the continuous improvement of technical manufacturing techniques for life cycle management in accordance with GxP, regulatory requirements and company policies and procedures. Author/Review/Execution Process Validation and Performance Qualification protocols for manufacturing processes. Author/Review of relevant CMC sections of regulatory dossiers and support regulatory compliance initiatives including gap analysis, responding to RFIs, regulatory incidents and post approval commitments. Contribute to the Technical strategy for the product portfolio. Manage and control costs in relation to Technical resources and projects. Relationships. Report directly to the Head of Tech Transfer. Manage a team of tech transfer and process specialists. Work cross functionally as a strong leader and establish effective partnerships with functional leads in MSAT/Development, Quality, Engineering, Manufacturing and Supply Chain. Act as a point of contact for the Technical information in manufacturing with clear understanding of the strengths of the developing SME network and how to access and use it. To work closely with the selected suppliers of raw materials and equipment during the development, tech transfer and implementation of new products, continuing through the lifecycle management of existing products. Management and coordination of expert external resources. Key Job Competencies. Leadership - exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others. Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions and works well in group problem solving situations. Commercial acumen gets involved in strategic decision-making within the business as an influencer. Able to understand company finances, resourcing and the ultimate aims of the business. Change Management - Develops workable implementation plans; communicates changes effectively; builds commitment and overcomes resistance; prepares and supports those affected by change; monitors transition and evaluates results. Cost Consciousness - works within approved budget; develops and implements cost saving measures; contributes to profits and revenue; conserves organizational resources. Motivation - sets and achieves challenging goals; demonstrates persistence and overcomes obstacles; measures self against standard of excellence; Planning/Organizing - prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans. Professionalism - approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments. Quality Management - looks for ways to improve and promote quality; demonstrates accuracy and thoroughness. Innovation - displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas. Oral Communication - speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates good presentation skills; participates effectively in meetings. Written Communication - writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information. Job Background. Scientific Degree or equivalent, preferably with a higher qualification in bio-pharmaceutical sciences. Substantial experience with Biologics process development, MSAT or Manufacturing. Knowledge of cell biology, fermentation, scale-up and bioreactor operation, chromatography operation, Tangential Flow Filtration (TFF), and aseptic filling. Excellent technical, diagnostic, and troubleshooting skills. Strong leadership and organizational abilities, including project management and risk management. Proficiency in managing, multiple, cross functional projects to deliver against key project milestones and deadlines. Experience of transferring pharmaceutical products from external organisations or process development into a GMP manufacturing environment. Knowledge of general regulatory compliance requirements and relevant ICH guidelines. Excellent communication, motivational, and interpersonal skills. Ability to work in a fast-paced environment essential. Experience in supporting EHS programs. NEBOSH qualification or equivalent would be advantageous. How to Apply: If youre interested in applying or want to know more about this job 1st, contact Darren Brown in CPL Limerick in complete confidence on 087 405 3774 or email your CV to darren.brown@cpl.ie.

406 days ago