Assoc. Director - Biologics Downstream Operations

Co. Meath
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A fantastic and hugely exciting opportunity has arisen for a Biologics Downstream Operations Associate Director. Reporting to the Downstream Operations Lead, this position will drive operational excellence by leading/participating in cross functional teams to deliver all components of a stable manufacturing team and process for Biologics clinical and commercial manufacturing at our new single-use commercialization facility. This position will provide leadership and operations support on Biologics drug substance (DS) manufacturing in addition to technical transfer, PPQ and approval of new products in the future. As part of the team, drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.

Bring energy, knowledge, innovation to carry out the following:

  • Manage, coach, and mentor the Downstream Operations team.  Build diverse talent with the capabilities necessary to succeed in commercial manufacture.  Inspire, reward and develop individuals, helping them to reach their potential. Resolve resource constraints and support resource needs and changes
  • Ensure right-first-time and stable start-up, including through technology transfer leadership, execution of clinical, PPQ and commercial batches, change management and implementation of process improvements
  • Drive a strong compliance mindset within the organisation, including proactive safety and quality culture, and adherence to all regulatory expectations
  • Ownership for ensuring permanent inspection readiness is in place
  • Ensure production and project milestones are achieved through planning and execution of integrated overall program schedule
  • Establish and deliver on KPI’s in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure
  • Lead and/or support various site functional and cross functional tier structures
  • Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and cost-efficient operating model. Be an advocate of continuous improvement in yield, cycle time, error reduction etc.
  • Drive a strong technical and digital mindset within the department, staying up to date with emerging technologies that will benefit the organization and manufacturing processes
  • Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site stakeholders
  • Responsible for prioritisation of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process
  • Provide clear direction and definition of any new project scope, goals and deliverables, to the site and cross-functional sub-teams on an on-going basis
  • Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders
  • Manage financial forecasts and workload to achieve departmental headcount and cost improvements.

General competencies:

  • Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high performance organizational culture that accommodates rapid growth & highly dynamic operating execution
  • The desire to continuously learn, improve and grow, and cultivate continued development within the team
  • Innovative thinker, with excellent decision-making and problem-solving skills
  • Ability to participate in and lead highly effective cross functional teams, build diverse talent, with a passion to build the future of the site
  • Ability to influence across organizational layers, as well as outside the site and externally with partners
  •  Ability to rapidly understand complex business & technical issues including multi-option scenarios to mitigate risk and ensure continuity of supply as well as strategic initiatives
  • A great communicator, decisive decision maker with a proven ability to deliver excellence

Technical competencies:

  • Proven capabilities in site manufacturing and technical operations, experience of Operational Excellence, Six Sigma and Lean Methodologies and a proven track-record in project management
  • Proven capabilities and knowledge of Biologics Drug Substance manufacturing, particularly in downstream processes
  • Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results
  • Knowledge of global and company health authority regulations and applicable systems & GMP requirements.  Experience engaging with regulatory agencies including in on-site inspections
  • Sound judgment and comfortable operating in a challenging, fast-paced and sometimes ambiguous environment.

Minimum Education/Experience:

  • Degree qualification or equivalent (Science, Engineering, Technical or other relevant studies)
  • Demonstrated leadership with at least 5 years leading in a cross-functional environment, including indirect or direct people management experience
  • Demonstrated biotech/vaccines/pharma manufacturing site, project or other relevant experience.

Important Dates
Posted on
10 May, 2024
Application deadline
24 May, 2024

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