Senior Bioprocessing Scientist

CPL

Shannon

Senior Bioprocessing Scientist  The main purpose of the Senior Bioprocessing Scientist is to drive day-to-day manufacturing processing and support Good Manufacturing Practice (GMP}-compliant activities for the production of sterile gene therapy Products. Candidates must hold a valid work permit/visa or EU citizenship to be considered. Job Responsibilities:  Plan work to achieve the most efficient use of personnel and resources. Support the development of manufacturing processing. Contribute to the training and development of others. Promote appropriate, effective communication within the manufacturing team. Assure the data integrity of all activities performed. Ensure area compliance with Quality, Safety and Environmental systems and procedures. Bioprocessing. Perform production processes, following SOPs and GMP practices to manufacture required products. Proficient in the use of aseptic manufacturing techniques to assure the manufacture of intermediate sterile products. Operate to appropriate GMP practices within clean room environment to ensure continued compliance within those areas. Carrying out the day-to-day monitoring of the GMP facility to ensure that the facility operates in a compliant and safe manner to allow the production of gene therapy products at the required standards. Perform routine cleaning of the manufacturing facility. Perform the environmental monitoring of the manufacturing facility. Ensure that the manufacturing facility and storage areas are maintained in a fit-for-purpose state. Conduct regular stock checks and assist in the maintenance of the stock inventory. Assist in stock control including ordering against defined specifications and receipt of materials, appropriate storage of starting biological products, (Quality Control QC) approval and release of materials for use. To ensure all equipment used is calibrated/maintained and in line with SOP's. Recognize and report procedural problems and deviations. Participate in the planning of duties to ensure customers receive products on time and in full. Key Performance Indicators. Aseptic technique qualification. GMP compliance. Contamination-free GMP Batch manufacture. Data integrity. Key Job Competencies. Aseptic processing -Operates appropriate manufacturing practices to avoid cross-contamination and sterile processing. Problem Solving -Identifies and resolves problems in a timely manner; able to gather and analyze information; develops alternative solutions; works well in group problem solving situations. Leadership -exhibits confidence in self and others. 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. 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 -meets challenges with resourcefulness; generates suggestions for improving work; develops innovative approaches and ideas. Job Background. Either BTEC HNC/HND or degree in a relevant scientific discipline with practical laboratory elements (or equivalent) or relevant previous experience. Experience in pharmaceutical product manufacture (preference for biologics and aseptic manufacture).  Leadership experience including planning, problem solving, training and personal development. Practical experience in sample preparation and analysis. Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred. Candidates must hold a valid work permit/visa or EU citizenship to be considered. To Apply: If this job sounds ideal to you & you want to enquire in complete confidence or make an application, contact Darren Brown in Cpl Limerick on 087 405 3774 or email your details to darren.brown@cpl.ie.

393 days ago