Ad Downstream Manufacturing

Fastnet The Talent Group

Dublin North, Dublin

An excellent opportunity has arisen for an Associate Director, Drug Substance Operations, Downstream, to play a pivotal role in the development of a new world-class biotechnology facility in North Dublin. This is a unique opportunity for the right person to shape, create, build and grow the downstream manufacturing operations with this leading innovative organisation. This person will provide operational expertise for all downstream manufacturing operations and coach project sub-teams to deliver all project activities and meet the required project schedule, playing a pivotal role in the manufacture of biologics-based medicines. As part of the senior leadership team in the Drug Substances Operations, the successful candidate will drive the design construction, validation, and start-up of its downstream manufacturing operations. This role requires a seasoned, action-oriented leader with proven capabilities in site manufacturing and technical operations roles, leadership, experience of Six Sigma and Lean methodologies, and a proven track-record in capital project management. A self-starter, the successful candidate will be technically strong and comfortable with the organisations collaborative leadership style and cross-functional team structures and will act with candour and courage to deliver a plant for the future, on time, and will have a strong willingness to design their own future within the organisation. Key Responsibilities: Responsible for the successful implementation of downstream operations and adherence to schedule milestones throughout the project duration. Create and execute a clear direction of project deliverables to the site and cross-functional sub-teams to bolster each team's understanding of their contribution in successfully delivering the project on time. Driving operational and technical excellence to deliver all components of a stable process for PPQ, facility start-up and commercial supply, supported by a flexible, collaborative, multi-skilled teamwork environment. Shape and instigate a strategy for start-up and overall downstream operations roll-out that successfully delivers right-first-time manufacturing of biologics for customers, including patients. Facilitate sound financial stewardship, effective site budget control, and resolve resource constraints when required. Solve problems and escalate risks in a timely fashion to the relevant on-site and above site stakeholders. Use lean principles across all technical aspects of the process, by deploying Merck Six Sigma tools and automation principles, to deliver a cost-efficient operating model for commercial production. Requirements. Third-level Degree (preferably Science, Engineering, and/or Technical. Minimum 8 years' experience in a people leadership role within Drug Substance. Experience with facility commissioning and startup. Demonstrating energy and enthusiasm, the Associate Director, Drug Substance Operations, Downstream, will be a role model for operational excellence, and will contribute to the organisation's overall capability to thrive and grow. Knowledge of and experience in applying Six Sigma and Lean methodologies. Ability to build and fostering relationships with project stakeholder groups including engineering, technical operations, quality and others. Technically-savvy leader with a deep understanding of Capital project management and execution and strong experience in biologics manufacturing. A strong understanding of project implementation strategy, including experience on regulatory, validation and process technology transfer will be key. Proven track record of leading site manufacturing and technical operations roles. He/She will champion trustworthy and ethical behaviours and build the operation's capabilities with the diverse talent needed to succeed in commercial manufacturing by inspiring and developing individuals to reach their potential. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2195 days ago