Senior Manufacturing Biotech Associate

<p>Job Description</p><p></p><p>An opportunity has arisen for the position of <b>Senior Manufacturing Biotech Associate</b> at our single-use Dunboyne facility.</p><p>As <b>Senior Biotech Associate</b> you will be part of a self-directed work team in Downstream Operations, responsible for all procedures and processes associated with the manufacture of Drug Substance. The<b> Senior Manufacturing Biotech Associate</b> leads by example by always upholding the highest standards of Safety, Quality, GMP, Right First Time  and Compliance.</p><p>Key responsibilities include the execution of an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a single use technology-based facility.</p><p>The Senior Biotech Associate will also be involved in optimising and improving processing activities through use of standard work and lean processing techniques, while consistently delivering on specific KPI’s. This role is focused on delivery to the patient through living the Dunboyne culture, including a commitment to safety, right first time in everything we do, and a focus on the engagement and development of self and peers. </p><p><b><span>What you will do:</span></b></p><p><b><span>Bring your energy, knowledge, and innovation to:</span></b></p><ul><li>As a senior team member, be strong technically, with an excellent grasp of processes and procedures. Already an SME on many processes, be strongly motivated to acquire knowledge and understand all Downstream processes to a micro level</li><li>Proactively train, coach and mentor less experienced team members, by being approachable, supportive, inclusive and generous with knowledge, while striving to work in a cohesive and proactive team, with a ‘never let a teammate fail’ mindset</li><li>Display flexibility, adaptability, innovation, with a reflexive ability to think on your feet, also possess a strong skill set for logical root cause analysis, and problem solving</li><li>Be an excellent communicator, and true team player with concern for others. Be able to deliver business unit goals through strong and cohesive collaboration with other departments, within a matrix reporting environment</li><li>Display high initiative and be ready to take responsibility; thinks ahead, seeks the production schedule daily, and lays plans to achieve or exceed it</li><li>Takes part in shift handovers and Tier meetings, raising concerns or issues promptly and providing options for resolutions.</li><li>Be actively involved by participating in inspections, GEMBA’s and Go-See’s, OPPS, improvement projects and other MPS initiatives</li><li>Perform EBR and documentation reviews, QN investigation and closure, and any other documentation or administrative tasks as directed by your manager</li><li>Utilise Lean Six Sigma Tools to support the initiative of continuous improvement (CI)</li><li>Be proficient to SME level with production systems such as MES, DeltaV, SAP, GLIMS, PROCAL and others</li><li>Deputises when required, to represent the department at meetings and discussions, and performs any other duties as appropriate when assigned by the Manager</li></ul><p><b>What skills you will need:</b></p><p>To excel in this role, you will more than likely have:</p><ul><li>A Level 7, or higher, qualification in a science or engineering discipline, with a minimum of 3 years’ experience in a GMP regulated Manufacturing environment.</li><li>Strong experience in a highly regulated pharmaceutical manufacturing environment</li><li>Excellent communication skills and the ability to work in a cross functional collaborative team</li><li>Willingness and ability to work 24/7 shift operations, which include days, nights and weekend work in rotation</li><li>Possess a detailed overview of the overall Upstream and Downstream processes, with expertise and working knowledge of the manufacturing process</li><li>Maintain a high level of expertise and working knowledge of the process equipment.</li><li>A proven ability to work with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V etc.</li><li>Strong knowledge and understanding of manufacturing GMP and quality systems</li><li>Demonstrate troubleshooting and problem-solving competency</li><li>Desire to learn and develop.  Ability to interact with multiple stakeholders across numerous departments</li><li>Knowledge and experience of Kanban, JIT, 5S and Lean Manufacturing methodologies</li><li>Ability to manage multiple priorities and know when to escalate issues for resolution.</li><li>Excellent trouble shooting skills as well as an ability to coach and mentor self-directed teams through complex problem solving. High degree of problem-solving ability and adherence to scheduled timelines.</li><li>A proven ability to deliver on tight timelines</li></ul><p></p><p>This position will support the manufa